Aenova at BioFIT 2025 in Strasbourg

Treffen Sie Aenova auf dem führenden Partering Event für Innovationen im Bereich early-stage Business.
Unter der Leitung seines...

07/12/2025 - Meet Aenova at the leading partnering event for innovation in early-stage business. - Aenova Group

02/12/2025 - Meet Aenova at BioFIT 2025 in Strasbourg

Strasbourg, 02/12/2025

Meet Aenova at the leading partnering event for innovation in early-stage business.
Steered by its prestigious committee, the BioFIT conference programme is shaped to correspond to the interests of every player in the sector and to meet the expectations of its stakeholders, whose sharp minds operate in the fast-paced Life Sciences sector. The 2025 programme is rooted in four custom-made tracks, addressing the right funding sources for early-stage innovation, best practices in academia-industry R&D collaborations, winning ways to nurture early-stage assets and animal health highlights.
Aenova will be a sponsor at BioFIT 2025.
With its new Aenovation™ program, Aenova is the ideal partner for complex molecules, bioavailability enhancement, preformulation, fast-track development, prototyping, the right formulation route, and scaling and market launch. Schedule a <a href="mailto:contact-sales@aenova-group.com">meeting</a> today. Meet Aenova at booth F19!

Aenova at Bio Convention 2025 in Boston

16-19/06/2025 - Aenova at Bio Convention 2025 in Boston

Boston, 16-19/06/2025

Join Aenova at the BIO International Convention in Boston, June 16-19, 2025. The largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with 20,000 industry leaders from across the globe.
You´ll find Aenova at booth #487.
In a time of remarkable discovery and progress, the biotechnology industry stands at the forefront of a revolution changing how we live, heal, and care. Aenova as a leading CDMO provides its customers a one-stop-shop experience, from pre-formulation and clinical trial material for FIH until a broad offering with its development services and scaling up to commercial supply.
Aenova offers services covering the entire value chain from development to commercialization for all common product groups and dosage forms (solid, semisolid, sterile, and nonsterile liquid). Aenova supplies drugs up to OEB 5 and food supplements and is also able to handle differentiated technologies such as HPAPI containment, low-dose, modified release formulations, organic granulation, particulate systems, lipid-based formulas, HME or spray drying for poorly soluble compounds.
Schedule a <a href="mailto:contact-sales@aenova-group.com">meeting with our sales team</a> now.

"Hot Melt Extrusion: Accelerating Drug Development for Poorly Soluble APIs"

17/09/2025 - Live Webinar "Hot Melt Extrusion: Accelerating Drug Development for Poorly Soluble APIs"

Live Webinar 17/09/2025. 9am EDT (NA) / 2pm BST (UK) / 3pm CEST (EU-Central)

In today’s pharmaceutical landscape, over 80% of R&D candidates in the global pipeline suffer from poor solubility, creating a significant challenge for effective drug delivery. To ensure that innovative medicines reach patients worldwide, advanced formulation and process technologies are necessary to overcome bioavailability issues, such as lipid-based systems and amorphous solid dispersions. This joint webinar by CDMO Aenova and extrusion technology provider Leistritz offers a special focus on hot melt extrusion (HME), providing a comprehensive guide to formulation and process development, equipment design and scale-up. Attendees will benefit from insights into how to make informed decisions when analyzing and choosing technology options for their processes. The session provides practical instruction on setting up HME processes. Based on a case study, this webinar will also provide evidence regarding strategies that can significantly accelerate formulation and overall product development.
Register for this webinar to benefit from the combined perspectives from market leaders in the CDMO area and extrusion technologies, offering a holistic view on HME implementation from formulation to equipment design.
The webinar will be held on the renowned webinar platform Xtalks. <a href="https://xtalks.com/webinars/hot-melt-extrusion-accelerating-drug-development-for-poorly-soluble-apis/?utm_source=EmailBanner&utm_medium=Leistritz&utm_campaign=25q224">Register here.</a>

Aenova at CPHI Europe

28-30/10/2025 - Meet Aenova at CPHI Europe

Frankfurt, 28/10/2025

Meet Aenova at CPHI Europe in Frankfurt, Germany.
This year's motto is "A global community advancing human health".
You will find Aenova at booth #5.0B58.
Discuss your projects with our experts and our sales team – whether it is
<ul><li> sterile fill & finish capacities,</li><li>high-volume state-of-the-art solids production,</li><li>innovative technologies for improving bioavailability (e.g. hot melt extrusion, spray drying, lipid-based systems), or </li><li>customized early-stage development: the Aenovation™ suite of services is specifically designed to deliver customized fast-track (pre-)formulation, maximizing your API's potential for patients</li></ul>
As a leading CDMO, Aenova can support you in all phases of your product.
Arrange a <a href="mailto:contact-sales@aenova-group.com">meeting with our team</a> today.

Starnberg

Aenova appoints Alexandre Pasini as Chief Operating Officer

25/11/2025 - Aenova appoints Alexandre Pasini as Chief Operating Officer

Starnberg, 25/11/2025

Aenova today announced the appointment of Alexandre Pasini as Chief Operating Officer (COO), effective November 1, 2025. Alex Pasini brings more than 25 years of leadership experience in the life sciences sector. Most recently, he led the Drug Product EU & APAC business unit at Thermo Fisher Scientific Inc. Prior to that, he held senior roles at Lonza Group Ltd., including Site Director and Head of Global Bioscience Operations, as well as global positions in supply chain and project management. He holds a postgraduate degree in econometrics and mathematical economics from the University of Geneva (CH), speaks four languages, and is certified as a Black Belt in Operational Excellence. “With Alex on board, we are reinforcing our commitment to operational excellence and efficiency across the entire value chain,” said Jan Kengelbach, CEO of Aenova Group. “This is a key step in strengthening Aenova’s position as a global CDMO partner, delivering best-in-class solutions from early development through commercial manufacturing.” “I’m excited to join Aenova and contribute to creating real value for our customers,” said Alex Pasini. “My focus will be on driving continuous improvement in production and supply chain to ensure reliable patient access worldwide.” The Aenova Group is one of the world’s leading CDMOs for the pharmaceutical and healthcare industries. As a one-stop shop, Aenova develops, manufactures, and packages all common dosage forms and product groups, from pharmaceuticals to dietary supplements for human and animal health. Around 4,000 employees at 14 production sites worldwide contribute to the company’s success.

Latina

Aenova expands sterile fill & finish manufacturing capacity at its Latina site

23/10/2025 - Aenova expands sterile fill & finish manufacturing capacity at its Latina site

Latina, 23/10/2025

Aenova announces a major investment in its sterile manufacturing capabilities with the installation of another fill & finish (F&F) line at its Latina site. This expansion marks a significant step in meeting the growing global demand for biologics manufacturing, particularly in late clinical and commercial phases. The Latina site is the Aenova Group's central sterile site, with many years of experience in sterile processing. The new fill & finish line will support a broad range of container formats, including vials ranging from 2R to 50R, pre-filled syringes (PFS) from 0.5mL to 50mL, and pre-filled cartridges (PFC) from 1mL to 20mL. This flexibility enables the site to accommodate a wide variety of product types and batch sizes. The new line will operate under isolator technology to ensure the highest standards of sterility and containment. It will be capable of processing a wide range of biologics, including monoclonal antibodies (mAbs), peptides, and vaccines. The fill & finish line will add an annual capacity of 30 to 40 million units. In total, the Latina site will be capable of producing over 100 million units per year, significantly enhancing its role as a strategic partner for biotech companies worldwide. The initiative responds to a clear market need: biotech and virtual companies are seeking reliable, flexible partners to support their products from clinical development through to commercial manufacturing. The construction is currently underway, with the installation of the equipment planned for 2026, and the qualification and start of GMP manufacturing scheduled in Q3 2027. Patients, partners, and clients will benefit from the site’s ability to handle highly sensitive and niche products, supported by a dedicated team of experts in tech transfer and scale-up who will ensure robust process implementation, regulatory compliance, and first-time-right approvals. This expansion is part of a broader investment strategy, with approximately € 100 million allocated over the next three years to enhance capacity and capabilities at the Latina site. In addition to the new line, this investment includes a cold chain warehouse and a comprehensively expanded QC laboratory. The Latina site is on a strong growth trajectory, and the expansion will also bring a strong focus on workforce development. During the project, nearly 100 new positions will be established, including positions in engineering, project management, equipment qualification, quality assurance and client services. The site will continue to strengthen its technical expertise in biologics fill & finish, placing a strong emphasis on client management and regulatory excellence. These assets make the site a unique resource for delivering life-saving medicines on time and in full compliance. "Our investment in the Latina site reflects our unwavering commitment to expanding our technology offering in sterile fill and finish capacity and capabilities," said Jan Kengelbach, CEO of the Aenova Group. "By combining cutting-edge technology with our extensive expertise, we are developing a facility that is ready for the future and will meet the evolving needs of the biologics market."<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_new-ff-line_nest-positioning_picture-IMA_1.jpg" data-image="575550" alt="Latina New Fill&Finish Line Detail"><figcaption>New fill & finish line at Aenova Latina site, nest positioning and RTU pickup (Photo: IMA Group)</figcaption></figure><figure><img src="https://www.aenova-group.com/content/_medium/Aenova_new-ff-line_Stoppering-detail_picture-IMA_1.jpg" data-image="575551" alt="Latina New F&F Line Detail"><figcaption>New fill & finish line at Aenova Latina site, stoppering detail (Photo: IMA Group)</figcaption></figure>

Aenova recognized as winner of the 2025 CDMO Leadership Awards Europe

22/10/2025 - Aenova recognized as winner of the 2025 CDMO Leadership Awards Europe

Starnberg, 22/10/2025

Aenova has been named a winner in the Small Molecule Dosage Form category at the 2025 CDMO Leadership Awards Europe. This honor highlights Aenova’s strong industry position and leadership in finished dosage form development and manufacturing across Europe and worldwide. Following its recognition at the Global CDMO Leadership Awards in March 2025, Aenova has once again earned distinction, this time at the European level. The award reflects the company’s ongoing commitment to quality, scientific excellence, and customer-focused service. More than 200 CDMOs were evaluated by pharmaceutical and biotech companies based on their recent outsourced projects within the last 18 months. Winners were selected solely on direct customer feedback, with data filtered to highlight organizations headquartered in Europe. CDMOs play a critical role in advancing pharmaceutical innovation by providing end-to-end services from development through commercial manufacturing. Aenova offers comprehensive capabilities for bringing small molecule drugs from concept to market, including solid, semi-solid, sterile, and non-sterile liquid dosage forms for global supply. The 2025 CDMO Leadership Awards Europe are organized by Outsourced Pharma and Life Science Connect, in partnership with Orientation Marketing as the research partner.

Aenova named industry-leading "Innovative Product Provider 2025" in the pharmaceutical sector

17/10/2025 - Aenova named industry-leading "Innovative Product Provider 2025" in the pharmaceutical sector

Starnberg, 17.10.2025

In the “Innovative Product Provider 2025” study, Aenova ranks first in the pharmaceutical industry. Conducted by the SZ Institute of the Süddeutsche Zeitung in collaboration with the Cologne-based analysis institute ServiceValue, the study evaluated company data through social media monitoring. The topics explored included innovation, product novelty, technology, and quality.
Mentions of 9,250 companies and brands from over 100 million freely accessible items of content on German-language domains were recorded, evaluated, and analyzed in a second step with regard to topic and tone. Aenova took first place with a perfect score of 100, setting the benchmark against which other renowned market competitors were evaluated. Due to its consistent focus on innovation in its corporate strategy, Aenova is frequently mentioned in online channels and is increasingly recognized as an innovative company.
 “This award recognizes the Aenova Group's innovative strength, from its modern formulation and development services and special technologies to its investments in sterile fill-and-finish and exceptional manufacturing capacities. It also acknowledges the company's dedication to sustainability, social responsibility, and training skilled employees,” explains Dr Susanne Knabe, Head of Corporate Communications & PR at Aenova.
<a href="https://servicevalue.de/rankings/pharmaunternehmen-59/">Link to the overall results of the ranking (in German language)</a>

Aenova unveils ambitious sustainability strategy for a more responsible future

09/10/2025 - Aenova unveils ambitious sustainability strategy for a more responsible future

Starnberg, 07/10/2025

The Aenova Group has announced its new, comprehensive sustainability strategy. The initiative focuses on environmental stewardship, social responsibility, and good governance, underscoring Aenova’s commitment to building a healthier future for the planet, its people, and society. Protecting the Planet: Aenova’s Environmental Commitments Aenova has set bold environmental targets to combat climate change and drive resource efficiency. By 2030, the company aims to reduce Scope 1 and 2 carbon emissions by 80% compared to its 2024 baseline. For Scope 3 emissions, Aenova has set the goal of achieving net zero by 2045, with a total reduction of 90%. Aenova is also transitioning to 100% renewable electricity across all its sites. In 2024 alone, the company tripled its solar panel capacity, reinforcing its commitment to clean energy at its 14 global manufacturing locations. All German sites have already earned ISO 50001 certification for energy management, highlighting Aenova’s progress in efficiency and sustainability. Beyond energy, Aenova is pursuing further initiatives to reduce water use and waste, integrate more sustainable raw materials, and introduce eco-friendly packaging solutions – all designed to safeguard natural resources for generations to come. Empowering People and Communities Aenova’s social strategy is centered on creating long-term value for employees, communities, and patients. The company is dedicated to fostering a safe, inclusive, and fulfilling workplace, with employee wellbeing and safety performance consistently outperforming industry benchmarks. Each Aenova site is committed to supporting at least one local community initiative, with plans to expand these efforts in the years ahead. Inclusive employment programs, partnerships with local charities, and the integration of people with disabilities are already embedded across the company. Aenova also partners with patient organizations relevant to its therapeutic focus, such as leukemia typing initiatives, ensuring patient needs remain at the heart of its mission. Strong Governance: The Foundation of Responsible Growth Integrity is central to Aenova’s approach to accountability, trust, and long-term impact. Strong governance ensures that values and responsibility guide every decision and action. By 2027, Aenova will implement a comprehensive legal register to ensure regulatory compliance across all operations and will evaluate the sustainability practices of all high-risk suppliers. Additionally, Aenova will establish a dedicated sustainability governance structure and pursue certifications including ISO 14001, 27001, 45001, and 50001 by 2028. A Future Built on Responsibility With this ambitious sustainability roadmap, Aenova is not only reinforcing its competitive edge but also redefining responsible leadership within the pharmaceutical industry. By linking business success with environmental and social progress, the company is paving the way for a more sustainable and compassionate future. “At Aenova, we believe that true innovation must go hand in hand with responsibility,” said Jan Kengelbach, CEO of Aenova. “This sustainability strategy is more than a plan – it’s a promise to future generations. We lead with purpose, act with integrity, and move forward with care.”

New 800 sqm microbiology quality laboratory at Aenova Latina site bolsters sterile capabilities

10/09/2025 - New 800 sqm microbiology quality laboratory at Aenova Latina site bolsters sterile capabilities

Latina, 10/09/2025

Aenova is significantly expanding its microbiology quality control (QC) laboratory at its Latina site. The project adds approximately 500 square meters of new laboratory space, bringing the total to around 800 square meters, and marks a major milestone in the site’s development. With the implementation of a significantly expanded new QC laboratory, Aenova will gain new and advanced laboratory capabilities. These include sterility testing for biologics using isolator technology, collection and trending of environmental monitoring data, bacterial ID technologies, and advanced techniques for monitoring viable particles, bioburden, and endotoxins. Operational workflows will be optimized through automation, which will enhance data reliability, ensure compliance with data integrity principles, and reduce cycle times. The expansion ensures full alignment with international regulatory standards and adheres to the highest quality standards, including those of the EMEA and FDA. Furthermore, the project creates positions for over 20 specialized analysts and technicians, allowing the laboratory to test more than 1,000 batches per year. Customers benefit from enhanced regulatory compliance and faster process times This expansion underscores Aenova’s commitment to innovation, reliability, and quality by design. Customers will benefit from faster and more reliable microbiological testing, improved turnaround times, and enhanced regulatory compliance, further positioning Aenova as a trusted and forward-thinking CDMO partner. Advanced and expanded sterile manufacturing capabilities at Latina site
The new QC laboratory is part of the broader “Expansion Latina” project, which also includes the implementation of a cold chain warehouse (full operational readiness expected by the first quarter of 2026) and a second fill & finish line for sterile injectable / biologics products. These initiatives aim to increase production capacity, ensure robust infrastructure, and attract new customers through state-of-the-art equipment and operational competence in sterile manufacturing. Construction of the new QC lab is expected to be completed in the third quarter of 2025. Regulatory approval by local authorities is anticipated in the fourth quarter of 2025, after which the laboratory will become fully operational. “With the new microbiology laboratory, Aenova Latina consolidates its role as a strategic partner for pharmaceutical companies, ensuring faster and more effective microbiological testing. This investment allows us to further raise quality standards and reduce time to market for our customers,” says Vittorio Tonus, Head of Quality Operations at Aenova´s Latina site.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_New-QC-Lab-Latina-site_1.jpg" data-image="574340" alt="QC Lab Latina Detail"><figcaption>Rendering (detail) of the expanded QC laboratory at Aenova in Latina (Source: Aenova)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_New-QC-Lab-Latina-site_2.jpg" data-image="574341" alt="QC Lab Latina"><figcaption>Rendering of the expanded QC laboratory at Aenova in Latina (Source: Aenova)</figcaption></figure>

Aenova ranks among the top German mid-sized companies in the pharmaceutical sector

21/08/2025 - Aenova ranks among the top German mid-sized companies in the pharmaceutical sector

Starnberg, 21/08/2025

Aenova has been ranked second best medium-sized pharmaceutical company in the prestigious evaluation by “Markt und Mittelstand” and “Die deutsche Wirtschaft.” The study evaluated 10,000 German companies from 15 industries. The "Mittelstand 10,000" index evaluates the top medium-sized companies in Germany. It is based on 39 criteria, including quantitative data such as turnover and number of employees, as well as qualitative factors such as innovation, sustainability, and social commitment. A scientific advisory board reviews the weighting of these criteria. The ranking is neutral and transparent and is based on a wide range of verified information. For Aenova, the award is the result of its strategic approach to providing advanced development services and innovative specialty technologies, combined with outstanding manufacturing capabilities. The company focuses on expanding innovative platforms for improving the bioavailability of active ingredients, such as hot melt extrusion and spray drying. It also works on micro-dosed capsules, fill and finish for sterile injectable drugs, and highly effective drugs, particularly in oncology. At the same time, Aenova stands out due to its high-volume manufacturing and packaging capacity. Aenova offers its customers added value through end-to-end services, from development to commercial manufacturing for all common dosage forms, thereby playing a key role in the global supply of medicines with its wide range of services. Link to the evaluation's overall results (in German language) <a href="https://www.marktundmittelstand.de/ratgeber/die-top-50-pharmaunternehmen-2025">Die TOP 50 Pharmaunternehmen 2025</a><a href="https://www.marktundmittelstand.de/ratgeber/die-top-50-pharmaunternehmen-2025"></a>

“Saving lives together.” Group-wide registration campaign at Aenova

01/08/2025 - “Saving lives together.” Group-wide registration campaign at Aenova

Starnberg, 01/08/2025

Under the mottos “Saving lives together. Helping leukemia patients,” Aenova launched a broad-based, group-wide registration campaign in early summer 2025 to help leukemia patients. Around 500,000 new cases of leukemia are diagnosed worldwide every year. In such a registration campaign, healthy employees can be typed and registered in a database so that they can potentially be available as stem cell donors for leukemia patients if a match is found. By registering, anyone can help save lives. The campaign was very well received and was supplemented by a patient talk at the Regensburg site, which specializes in the manufacture of cancer drugs and immunosuppressants. How does a registration campaign work?
<ul><li> It begins with expert information and education on the topic of registration and stem cell donation.</li><li>This is followed by the collection of the donor's data.</li><li>Finally, a simple cheek swab is taken. The cells collected are used to determine tissue characteristics and are entered into a global stem cell database.</li></ul>
 The registration campaigns are carried out at Aenova's five locations in Bavaria in collaboration with the experienced teams of the non-profit organization “Stiftung Aktion Knochenmarkspende Bayern e.V.” (Bavarian Bone Marrow Donation Foundation). Regional organizations are also involved as partners at the other Aenova Group locations. The group-wide registration campaign is another building block in Aenova's corporate social responsibility program. "As a CDMO, the Aenova Group is an important player in global pharmaceutical supply. Our customers – and therefore patients worldwide – are our top priority. With our registration campaign “Saving lives together. Helping leukemia patients,” we can provide additional help, because every registration counts,“ explains Dr. Susanne Knabe, Head of Corporate Communication. ”This is a great joint success. Thank you to all employees who have already registered and who are participating in the campaign!"
<figure><img src="https://www.aenova-group.com/content/_medium/Typisierungsaktion-RGB.jpg" data-image="573122" alt="Registration campaign and patient presentation"><figcaption>Registration campaign and patient presentation (photos: Aenova)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/_medium/AKB-RGB-Prozess-Typisierung.jpg" data-image="573123"><figcaption>Detailed information about the campaign before the cheek swab is taken (photos: Aenova)</figcaption></figure>

Killorglin

Aenova launches new state-of-the-art spray drying platform at Killorglin site

21/07/2025 - Aenova launches new state-of-the-art spray drying platform at Killorglin site

Killorglin, 21/07/2025

Aenova is expanding its site in Killorglin with a spray drying platform for amorphous solid dispersions (ASD) and inhalation powders. The brand-new laboratory- and pilot-scale equipment is aimed at developing formulations for innovative drug candidates to overcome bioavailability hurdles, which are one of the greatest challenges in modern drug development. Spray drying as a core technology for improving bioavailability With approximately 80% of preclinical drug candidates facing bioavailability limitations due to poor solubility and permeability, Aenova is committed to unlocking the full therapeutic potential of these compounds. Aenova’s science-driven formulation strategies, including spray drying and hot melt extrusion for amorphous solid dispersions (ASDs), are designed to efficiently and effectively overcome such barriers. This accelerates the path from development to the market, ensuring that patients have faster access to innovative treatments. State-of-the-art spray drying capabilities With the new equipment at its Killorglin site, Aenova offers both laboratory-scale and pilot-scale spray drying capabilities, supplied by Büchi and GEA, enabling flexible development from early-stage research through to clinical supply. The project is supported by the Irish Government through IDA Ireland, and the expansion will also lead to the creation of new positions in the areas of R&D, pharmaceutical technology and analytics. The Aenova Killorglin site can handle active pharmaceutical ingredients (APIs) up to OEB 4, as well as organic solvents. “With nearly 50 years of experience in granulation, modified-release coating, encapsulation, extraction, and spray drying, the site provides customers with long-standing expertise and in-depth knowledge. Close collaboration with scientific researchers at the universities of Cork and Limerick promotes innovative, research-oriented approaches”, says Aidan Spillane, managing director at Aenova’s Killorglin site. “As an end-to-end CDMO, Aenova supports its customers throughout the entire drug product lifecycle, from pre-formulation and development to commercial manufacturing. Bioavailability plays a pivotal role in the success of new pharmaceutical compounds. With our new spray drying platform in Killorglin, we significantly expand our range of solutions to help customers overcome bioavailability hurdles and accelerate time-to-market,” says Florent Bordet, Chief Scientific Officer at Aenova. The opening ceremony took place on Friday, July 18, 2025.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Opening-Ceremony_Spray-drying.jpg" data-image="572938" alt="Opening Ceremony Killorglin"><figcaption>Florent Bordet, Chief Scientific Officer at Aenova, Michael Lohan, CEO of IDA Ireland, Norma Foley, Minister for Children, Disability and Equality and Aidan Spillane, Managing Director at the Aenova Killorglin site at the opening ceremony (Photo: IDA Ireland)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Lab-scale-spray-drying_Killorglin.jpg" data-image="572939" alt="Spray Drying Killorglin lab-scale"><figcaption>Lab-scale spray drying development at Aenova Killorglin (Photo: Aenova)</figcaption></figure>

Regensburg

Aenova expands its advanced technology portfolio with cutting-edge hot melt extrusion platform

09/07/2025 - Aenova expands its advanced technology portfolio with cutting-edge hot melt extrusion platform

Regensburg, 09/07/2025

Aenova relies on various innovative technologies to improve the oral bioavailability of poorly soluble pharmaceutical active ingredients. These include a new hot melt extrusion platform, which Aenova has now introduced at its Regensburg site. This twin-screw extrusion platform is ready to be used in producing amorphous solid dispersions (ASD) for APIs up to OEB 5. Unlocking the Full Potential of Drug Candidates Approximately 80% of preclinical drug candidates face bioavailability limitations due to poor aqueous solubility and slow absorption in the gastrointestinal tract. These issues can delay clinical development and hinder the delivery of life-changing therapies to patients. Aenova’s science-driven formulation strategies, including hot melt extrusion and spray drying for amorphous solid dispersions (ASDs), are designed to overcome these barriers efficiently and effectively. Hot melt extrusion: a key technology for bioavailability enhancement Hot melt extrusion (HME) is one of the most effective and versatile technologies for improving the bioavailability of poorly soluble compounds. The process transforms the crystalline structure of the API into an amorphous solid dispersion, significantly enhancing its solubility and dissolution rate.
 At Aenova’s Regensburg site, the new HME platform equipped with cutting-edge technology from manufacturer Leistritz enables seamless scale-up from lab-scale development to full GMP production. This ensures speed, consistency, and cost-efficiency across the product lifecycle. A center of excellence for high-potency formulations The Regensburg site is fully equipped to handle highly potent compounds up to OEB 5 (OEL &lt; 1 µg/m³) and features comprehensive in-house API characterization and analytical capabilities. With decades of experience in formulation science, polymer selection, process optimization, and Quality-by-Design product development, Aenova delivers customized, first-time-right solutions that unlock the full therapeutic potential of complex drug candidates. “With our new hot melt extrusion technology, Aenova is expanding its range of innovative platforms to provide modern, end-to-end solutions for our customers' poorly soluble molecules, from pre-formulation and development to commercial manufacturing,” says Florent Bordet, Chief Scientific Officer at Aenova.<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Hot-Melt-Extrusion-Technology_Regensburg-sq.jpg" data-image="572664" alt="HME in Regensburg"><figcaption>Hot melt extrusion technology at the Aenova site in Regensburg (Photo: Aenova)</figcaption></figure>

Aenova publishes Annual Report 2024

30/06/2025 - Aenova publishes Annual Report 2024

Starnberg, 30/06/2025

In the Annual Report, Aenova once again reflects on an extremely successful fiscal year with a very strong performance. For the second consecutive year, the company has achieved its most successful results to date. This outcome clearly demonstrates the sustainable impact of the company's strategic direction. The Annual Report provides insights into the financial development of 2024 and highlights milestones from the past fiscal year.
 These include:<ul><li>EBITDA has shown significant growth, with an 18% increase.</li><li>Net sales have reached a new high of EUR 868 million.</li><li>The total amount of investments stands at EUR 86 million.</li><li>The Employee Net Promoter Score has increased by 10%.</li><li>Kuehne Holding AG becomes majority shareholder of Aenova.</li></ul>
The Aenova Annual Report 2024 is available for download <a href="https://www.aenova-group.com/content/Aenova_Annual-Report_2024.pdf">here</a>.

Aenova expands cold chain capabilities with new state-of-the-art warehouse at its sterile site in Latina

27/06/2025 - Aenova expands cold chain capabilities with new state-of-the-art warehouse at its sterile site in Latina

Latina, 27/06/2025

Aenova is investing in a new cold chain warehouse at its sterile site in Latina, Italy. The cutting-edge facility marks a significant milestone in Aenova’s commitment to providing end-to-end integrated supply chain solutions for biologics and other temperature-sensitive pharmaceutical products. The new warehouse, adjacent and fully connected to the existing facility, represents a strategic expansion of Aenova’s cold chain infrastructure. Construction began earlier this year, with full operational readiness and regulatory acceptance expected by the first quarter of 2026. Spanning approximately 6,500 cubic meters, the warehouse offers a total capacity of 1,300 pallet spaces, with an additional area accommodating around 100 pallet spaces dedicated to packing, shipping, and final product preparation. The facility is designed to maintain a controlled temperature range of 2–8°C, which is continuously monitored and recorded via a SCADA system (Supervisory Control and Data Acquisition), ensuring full compliance with current Good Manufacturing Practices (cGMP). The warehouse is fully automated, with an integrated digital system for precise location tracking and pallet movement. Goods are transferred between production and storage areas using an Automated Guided Vehicle (AGV) system, and all time-of-refrigerator (TOR) data is digitally recorded. To ensure uninterrupted operations, the facility is equipped with two independent refrigeration systems that back each other up, providing robust business continuity. Additionally, the warehouse incorporates state-of-the-art technologies that enhance energy efficiency and support Aenova’s sustainability goals. A dedicated freezer area is also included for the storage of drug substances, further expanding the site’s capabilities. “This expansion significantly enhances our biologics and sterile drug product offering,” says Paolo Abbate, Managing Director at the Aenova site in Latina. “By integrating cold chain storage directly into our manufacturing site, we can now offer our customers secure and streamlined logistics; this is a real competitive advantage in terms of speed, reliability, and compliance.” The new facility is designed to support a wide range of cold chain products without requiring special adaptations for specific APIs or countries, making it a versatile solution for global pharmaceutical partners. This development further strengthens Aenova Latina’s position as a premier CDMO partner in sterile manufacturing, offering a comprehensive suite of services from drug substance to finished product all in one place. This is already paving the way for the expansion of the site with an additional fill & finish line for biologics planned for the upcoming years.<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_New-Cold-Chain-Warehouse_cl.jpg" data-image="572472" alt="Latina new cold-chain warehouse"><figcaption>The new cold chain warehouse at Aenova's Latina site will go into operation in the first quarter of 2026.</figcaption></figure>

Exclusive interview with Aenova CEO Jan Kengelbach: Building Europe’s Top-Tier CDMO

23/05/2025 - Exclusive interview with Aenova CEO Jan Kengelbach: Building Europe’s Top-Tier CDMO

Starnberg, 23/05/2025

Aenova CEO Jan Kengelbach recently granted an exclusive interview to the renowned business magazine Executive Forecast.
Jan Kengelbach provides insights into the strategy that will lead the company into a new era of growth. He also discusses new technologies and programs at Aenova, all of which aim to provide the most reliable supply of medications to customers and ultimately patients worldwide. The following topics were also addressed: 
<ul><li>Aenova Group's key priorities</li><li>Aenova's transition from venture capital to private ownership</li><li>Industry trends</li><li>Aenova´s long-term investments</li><li>Sustainability strategy</li><li>Company culture</li></ul>
Find out more in the full interview <a href="https://www.executiveforecast.com/conversation/building-europes-top-tier-cdmo-jan-kengelbach-chief-executive-officer-aenova-group" target="_blank">here</a>.
<figure><img src="https://www.aenova-group.com/content/_medium/Thumbnail-JK_ExecF_vf-1.jpg" data-image="572076"></figure>

Aenova launches Aenovation™ program to accelerate pharmaceutical development

07/05/2025 - Aenova launches Aenovation™ program to accelerate pharmaceutical development

Starnberg, 07/05/2025

Aenova announces the launch of its innovative Aenovation™ program. This new initiative is designed to fast-track early development of pharmaceutical formulations, specifically addressing the critical challenges of bioavailability and time-to-market for poorly soluble drug candidates. More than 80% of drug candidates fall into either the Biopharmaceutics Classification System (BCS) Class II (poor solubility, high permeability) or Class IV (poor solubility, low permeability). Many of these poorly soluble compounds address areas of high unmet medical need, requiring an accelerated development to bring these critical therapies to patients more quickly. Consequently, time-to-market and resource-efficiency are key competitive advantages. Aenova's CDMO strategy to meet these market demands ranges from strengthening its development services in general by implementing innovative technologies and platforms to improve bioavailability to the new Aenovation™ program to accelerate early-stage development, as the formulation process is a critical part of any drug development pipeline. Key features of the Aenovation™ program The Aenovation™ program is designed to streamline pharmaceutical development deploying a science-based rationale selection of formulation and technology. The program approaches pre-formulation and formulation development in three steps: First, API profiling and developability classification involves a thorough assessment and testing of the API to understand its solubility, permeability, solid-state properties, and powder physical characterization. This step ensures a well-founded developability classification, which guides the formulation strategy. Second, the formulation and prototype selection phase include a fast and API-sparing screening program that utilizes solubility enhancement technologies. This phase encompasses process simulation, analytical characterization, accelerated stability assessment programs, and the supply of prototypes for pre-clinical studies. Finally, the early clinical phase material manufacturing includes seamless transfer to GMP lab- and pilot-scale environments. This phase involves validating analytical methods and supplying materials for first-in-human clinical trials in record time. The Aenovation™ program is science-based and provides a proven way to rapidly advance innovative substances into early clinical phases (first-in-human). It is designed around comprehensive, proven protocols that cover all relevant formulation options and technologies. This structured approach enables pharma innovators including biotech start-ups to achieve significant benefits: rapid development, right-first-time results and efficient processes. Thus, the Aenovation™ program is a kick-start for preclinical and early clinical phases, but also a catalyst for accelerating biotech innovation. Comprehensive development services and innovative technologies for enhanced bioavailability Aenova’s services span the entire value chain from development to commercialization, covering all common product groups and dosage forms, including solid, semisolid, sterile, and non-sterile liquid forms. The company’s extensive technology offering includes spray drying, hot-melt extrusion, lipid-based systems, capsule micro-dosing, and designed release formulations. More than 170 scientists and analysts in seven specialized development centers support early drug development for the customers and ultimately patients worldwide. In addition, Aenova is continuously expanding its range of services by investing in new technologies and capacities. With this broad range of services, many options are available for improving the bioavailability of new and difficult-to-handle APIs or new chemical entities (NCEs) from preclinical development to the commercial production. With all steps from a single source, Aenova offers its customers seamless processes from the beginning to the end of the drug product life cycle. “Aenova’s extended range of development services allows us to support pharmaceutical and biotech companies in accelerating their programs and optimizing their resources,” said Florent Bordet, Chief Scientific Officer at Aenova. “Our Aenovation™ program is a reflection of our commitment to innovation and excellence in pharmaceutical development.” By streamlining the development process, Aenova helps deliver critical therapies to patients faster and more reliably.<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Aenovation_Labor.jpg" data-image="571546" alt="Aenovation"><figcaption>The new Aenovation™ program is designed to accelerate the development of pharmaceutical formulations at an early stage. (Photo: Aenova)</figcaption></figure>

New Whitepaper "Bioavailability Enhancement Strategies for Poorly Soluble Drugs"

22/04/2025 - New Whitepaper "Bioavailability Enhancement Strategies for Poorly Soluble Drugs"

Starnberg, 22/04/2025

Aenova has published a new whitepaper addressing one of the pharmaceutical industry's most pressing R&D challenges: improving the bioavailability of poorly soluble drug candidates. Titled “Acceleration development of poorly soluble drug candidates through quality-by-design,” the new whitepaper explores innovative approaches to enhance the solubility and bioavailability of difficult-to-formulate APIs. With over 80% of new drug compounds falling into Biopharmaceutics Classification System (BCS) Class II and IV - categories characterized by poor aqueous solubility - there is a growing urgency to adopt advanced formulation strategies that can bring these therapies to market faster, especially in areas of high unmet medical need. Drug developers must therefore have a wide range of techniques to address solubility challenges presented by new generations of drug candidates. Aenova presents a science-based, data-driven approach to formulation and recommends comprehensive pre-formulation programs that use active pharmaceutical ingredients (APIs) sparingly for technology screening to overcome the challenges of bringing new, poorly soluble drug candidates to clinic. Quality-by-Design (QbD) is a structured pharmaceutical development approach that ensures quality is built into the product from the beginning by thoroughly understanding product properties and process controls. QbD is particularly valuable in the formulation development of poorly soluble drugs, helping developers identify key parameters influencing solubility and bioavailability. By incorporating a data-driven QbD approach, developers can mitigate the cost and time implications of late-stage setbacks. The new whitepaper from Aenova describes several approaches, including how technologies such as hot melt extrusion and spray drying can be used to create amorphous solid dispersions with great success. “These technologies are not only scientifically advanced but also scalable and economically viable, allowing for streamlined development even under accelerated timelines,” said Dr Klaus Pollinger, Group Director Global Product Development at Aenova. “Our latest whitepaper offers valuable insights for pharmaceutical developers seeking to overcome solubility barriers and deliver more effective therapies to patients.”
The whitepaper is available for <a href="https://www.aenova-group.com/content/Aenova_Whitepaper_Bioavailability-Enhancement_Quality_by_Design.pdf">download now</a>.

Cornu

Aenova Gummy Symposium for the opening of the new gummy line

04/04/2025 - Aenova Gummy Symposium for the opening of the new gummy line

Cornu, 04/04/2025

At the end of March, a major customer event took place at the Aenova site in Cornu to showcase the new Aenova gummy platform, the Aenova Gummy Symposium.
 We were pleased to welcome around 40 customer representatives to this event. The program included key lectures on the new dosage form, interesting expert presentations on Aenova's offerings, the plant, taste masking and regulatory issues for pharmaceutical gummies. A factory tour and a folklore evening rounded out the program, which also provided a good opportunity for discussion and networking. Our gummy event was a huge success! A big thank you to all our valued customers and partners for your participation and the great feedback on this event! Gummies are a very helpful form of administration, especially for children, but also for adults and anyone who has difficulty swallowing or digesting medication. With the new gummy offering, Aenova provides its customers with a completely new platform that serves an attractive market and where Aenova has a competitive advantage in terms of experience, flexibility and market presence.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova-Gummy-Event-1.jpg" data-image="570317"></figure>
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova-Gummy-Event-2.jpg" data-image="570318"></figure>

Münster

Aenova supports St. Mauritz child and youth welfare service with a donation of 2,500.00 euros

01/04/2025 - Aenova supports St. Mauritz child and youth welfare service with a donation of 2,500.00 euros

Münster, 01/04/2025

Last week, Aenova presented St. Mauritz child and youth welfare service in Münster with a symbolic donation cheque for 2,500.00 euros. The fundraising campaign was initiated at the annual Aenova Sales Conference, which took place at the end of January at the Aenova site in Münster. Kinder- und Jugendhilfe St. Mauritz in Münster is one of the leading child and youth welfare facilities in Westphalia, Germany. It specializes in trauma education and currently offers around 200 places for girls and boys of all ages, supplemented by curative day groups. Special features include a class for diagnostic support and the opportunity to offer children and young people a “time out” in an adventure-based holiday camp. With its special trauma education concept and a wide range of other therapeutic and diagnostic services, the child and youth welfare service provides support in every life situation with a fast and flexible help system Aenova is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industry. Tablets and capsules with low-dose, high-potency active ingredients are developed, produced and packaged at the Münster site, which employs around 250 people. The site's long tradition in the field of contraceptives and narcotics is now complemented by modern production technologies, for example for low-dose capsules with dry powder for inhalation. "We want to support the important work of the St. Mauritz Child and Youth Welfare Service and use the Aenova donation to contribute to a better life for young people in need," explains Dr. Emil Wolf, Managing Director at the Aenova site in Münster "We are very pleased about the donation from Aenova. We will use the donation for equipment and safety material in the area of adventure and garden education, e.g. for carabiners, ropes and helmets," explains Michael Kaiser, Managing Director and Home Manager of St. Mauritz Kinder- und Jugendhilfe.
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Spenden-Scheck_St-Mauritz-Muenster_qu.jpg" data-image="570219" alt="Übergabe Spendenscheck Münster"><figcaption>Handover of the Aenova donation check to St. Mauritz Kinder- und Jugendhilfe in Münster. From left: Dr. Emil Wolf, Managing Director of Haupt Pharma Münster GmbH, Member of the Aenova Group, Michael Kaiser, Managing Director and Home Manager of St. Mauritz Kinder- und Jugendhilfe, Markus Rampe, Head of Business Operations, Aenova Münster.</figcaption></figure>

New Managing Director at Aenova's Regensburg site

21/03/2025 - New Managing Director at Aenova's Regensburg site

Regensburg, 21 March 2025

Dr Nancy Thiels has been appointed Managing Director of Haupt Pharma Amareg GmbH, the Regensburg site of Aenova, effective February 4, 2025. The experienced Managing Director will lead the site with more than 350 employees and focus on the development and production of highly effective solid oral dosage forms. The Regensburg site is a competence center for the development, production and packaging of highly effective pharmaceutical products within the Aenova network, in particular anticancer and immunosuppressive drugs in solid oral dosage forms (tablets and capsules). Significant capacity expansions are planned at the Regensburg site over the next few years in close cooperation with customers. Dr Nancy Thiels has been responsible for business development at Aenova's Regensburg site since February 4, 2025. She replaces the long-time Managing Director Oliver Schmied, who is taking on new challenges. Dr Nancy Thiels studied mechanical engineering at the Technical University of Kaiserslautern, Germany, where she also obtained her PhD. She has extensive experience in pharmaceutical production and process optimization in leading global companies, where she held various management positions for many years. "I am looking forward to my new role and the dedicated team in Regensburg. Every day, we develop and manufacture life-saving medicines for our customers, making an important contribution to the health of patients worldwide," explains Dr Nancy Thiels, Managing Director of Aenova’s Regensburg site. "At the same time, the focus is on continuous improvement, increasing efficiency and transforming the site as part of the Aenova Group's strategy." "With Dr Nancy Thiels, we have gained an experienced expert who knows the industry inside out. Under her leadership, the Aenova site in Regensburg will continue to pursue its high standards of excellence and innovation," says Jan Kengelbach, CEO of the Aenova Group.
<figure><img src="https://www.aenova-group.com/content/navigation/_portrait/569820/Aenova_MD-Regensburg_Nancy-Thiels.jpg" data-image="569820" alt="Neue Geschäftsführerin am Aenova-Standort Regensburg"><figcaption>Dr Nancy Thiels, is the new Managing Director at the Aenova site in Regensburg (Photo: private)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/company/sites/_medium/20240409_Aenova_Regensburg15378-1.jpg" data-image="567607" alt="Regensburg Produktion Blisterlinie"><figcaption>At Aenova's Regensburg site, anti-cancer drugs are developed, produced and packaged (Photo: Aenova)</figcaption></figure>

Aenova recognized as a winner of CDMO Leadership Awards 2025

06/03/2025 - Aenova recognized as a winner of CDMO Leadership Awards 2025

Starnberg, 06/03/2025

Aenova, one of the world's leading contract development and manufacturing organizations, has been selected as a winner in the "Small Molecule Dosage Form - Global" category of the prestigious CDMO Leadership Awards 2025. This underlines the company's global role and recognition in the field of Finished Dosage Forms. The CDMO Leadership Awards recognize the best contract development and manufacturing organizations (CDMOs) across global and regional categories. Aenova was selected as a participant in the CDMO Leadership Awards 2025, which identifies the best in the industry. More than 210 CDMOs were assessed by global pharmaceutical and biotech customers, based on their work with the providers, on an outsourced project within the past 24 months. Clients submit their ratings of CDMOs based on their recent projects, and the feedback is reviewed to identify the leading CDMOs in each category. Aenova has now been recognized as a winner of the 2025 CDMO Leadership Awards in the Small Molecule Dosage Form - Global category. The company is also a finalist for a Champion Award in the same category. Contract Development and Manufacturing Organizations (CDMOs) are critical partners to the pharmaceutical industry, providing end-to-end services from development to commercialization. Aenova offers the expertise and infrastructure required to bring small molecule drugs from concept to market. This includes the manufacture of all common types of solids, semi-solids, sterile and non-sterile liquids for the global supply of pharmaceutical products to customers and ultimately patients. Approximately 4,000 employees at 14 production sites contribute to the success of the company. This is reflected in Aenova winning the prestigious 14th annual Outsourced Pharma CDMO Leadership Awards. "We are very proud to be recognized as a leader in the CDMO industry with this award. It is of particular relevance as it is voted for by our customers, whom we realize have a choice of who they outsource to and vote for. We now look forward to the announcement of the champion among the winners at the awards ceremony in New York on March 19, 2025," said Neil Jones, Chief Commercial Officer of Aenova. “We are thrilled to introduce our 2025 CDMO Leadership Awards finalists to the Outsourcing community, and honored to offer such an important tool for drug sponsors in selecting their best-fit partner to help bring life-saving therapies to market,” says Outsourced Pharma Chief Editor Louis Garguilo. “The new categories and enhanced scoring methodology that went into this year’s appraisal bring an improved experience for drug sponsors using the resource as well as an ever-so-coveted distinction for the CDMOs. The unveiling of the award champions during our celebration in March will be an exciting new addition to the festivities.”<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Winner-CDMO-Leadership-Awards.png" data-image="569291" alt="Aenova CDMO Leadership Awards 2025"><figcaption>CDMO Aenova is recognized as a winner of the CDMO Leadership Awards 2025 in the category “Small Molecule Dosage Form – Global”.</figcaption></figure>

Bad Aibling

Aenova invests in packaging and production at its Bad Aibling site

04/03/2025 - Aenova invests in packaging and production at its Bad Aibling site

Bad Aibling, 04/03/2025

Aenova is expanding its Bad Aibling site. With a total investment of around 20 million euros in new production and packaging lines, the site offers a modern, high-volume infrastructure for the production of effervescent products and blister packaging. Aenova is a leading global contract development and manufacturing organisation for the pharmaceutical and healthcare industries with approximately 4,000 employees and 14 production sites. At the Bad Aibling site, the competence center for blister packaging / third party packaging and for high volumes of effervescent products within the Aenova network, a total of around 20 million euros is now being invested in modernizing the machinery. Another new blister line was just put into operation in February 2025. With ultra-modern, fast blister lines and a capacity of around 220 million blisters per year, customers in the blister and third-party packaging sector can now be served even better. In the area of effervescent products, another new strip packaging line was successfully commissioned at the beginning of the year. This means that two strip lines and one tube line are now available for effervescent products. More than 420 million effervescent tablets per year can now be produced and packaged in Bad Aibling. Further investments will follow, including a new explosion-proof fluid bed granulator for organic granulation. As a result, the site has a modern infrastructure that enables shorter delivery times and can grow with the customer. "With these major investments, we can offer significantly increased production capacity on state-of-the-art, high-speed equipment and position ourselves as a preferred and strategic partner for our customers," explains Thomas Lemke, Managing Director of the Aenova site in Bad Aibling.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Effervescent_Stripline_Bad-Aibling-1.JPG" data-image="569229" alt="Aenova Bad Aibling neue Stripline"><figcaption>Aenova is expanding at its Bad Aibling site with another new strip line for effervescent tablets (photo: Aenova)</figcaption></figure>

Lean management initiatives at Aenova: interdisciplinary exchange of experiences with experts

16/01/2025 - Lean management initiatives at Aenova: interdisciplinary exchange of experiences with experts

Bad Aibling, 16/01/2025

At the end of last year, Aenova's Bad Aibling site hosted the 20th meeting of the Lean Six Sigma experience exchange of the Kufstein University of Applied Sciences. Around 25 visitors from ten different companies in a wide range of industries accepted the invitation.The aim of the Lean Six Sigma experience exchange group is to strengthen lean management and Six Sigma in regional companies in Tyrol and southern Bavaria. The network currently includes 30 companies. At the invitation of Aenova, the Lean Management experience group from the Kufstein Tirol University of Applied Sciences met at the Aenova plant in Bad Aibling to discuss potential for continuous improvement during a tour of the production facility, a so-called Gemba-Walk. The motto of the day at Aenova was “OEE Improvement and Aenova Manufacturing System (AMS) as a shop floor management tool”. The Aenova Manufacturing System was introduced in 2020 as a shop floor management and reporting tool at all Aenova production sites. OEE measures overall equipment effectiveness. Feedback and suggestions for improvement from visitors in all areas were expressly encouraged in order to optimize the company's own processes based on the feedback. Visitors from outside the industry were particularly able to identify areas for improvement and exploit optimization potential. This exchange of experiences was once again a real success story of a regional cooperation idea..
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova-Bad-Aibling-Lean-Six-Sigma-Treffen.jpg" data-image="568103" alt="Lean Six Sigma Erfahrungsaustausch"><figcaption>Participants in the exchange of experiences at Aenova in Bad Aibling.</figcaption></figure>

10,000 euros for the Bavarian Bone Marrow Donation foundation: Aenova presents donation check

04/12/2024 - 10,000 euros for the Bavarian Bone Marrow Donation foundation: Aenova presents donation check

Starnberg, 04/12/2024

Aenova recently held a fundraising event for the Bavarian Bone Marrow Donation foundation (AKB - Stiftung Aktion Knochenmarkspende Bayern). Aenova employees donated to the AKB's stem cell donor registry, which finds suitable donors for leukemia patients worldwide and the company topped up the amount to 10,000 euro. The check was presented yesterday at the AKB in Gauting. Aenova is a leading contract developer and manufacturer for the pharmaceutical industry based in Starnberg/Percha, Germany. With around 4,000 employees and 15 sites worldwide, the company contributes to the global supply of medicines. The medicines manufactured by Aenova also include drugs for the treatment of cancer, such as leukemia, and immunosuppressants. The non-profit foundation Stiftung Aktion Knochenmarkspende Bayern (AKB) in Gauting operates the third largest stem cell donor registry in Germany. Every day, the AKB personally looks after around three to five donors who give their healthy stem cells to a leukemia patient for a stem cell transplant.
Leukemia patients need anticancer drugs to fight the disease and, afterstem cell transplantation, immunosuppressants to suppress the immune system's defensive reactions. Looking for support in the fight against leukemia, Aenova and the AKB came into contact. Coincidentally, the founder and CEO of AKB, Dr. Hans Knabe, and the Head of Corporate Communication and project manager at Aenova, Dr. Susanne Knabe, share the same lastname. As part of a first collaboration, patient representatives from AKB introduced themselves to Aenova employees at an internal event. The lively presentation by the two former cancer patients emphasized the importance of a reliable supply of medication. The subsequent appeal for donations raised a large sum, which the company generously rounded up. The donation check for 10,000 Euro was symbolically handed over at AKB in Gauting on December 4, 2024.
"We would like to thank Aenova and its employees for their generous donation. In addition to typing, financial donations are one of the most important pillars of our work for leukemia patients," explains Dr. Hans Knabe, founder and chairman of the Bavarian Bone Marrow Donation Campaign Foundation. “Any healthy person can also help and register as a stem cell donor; the typing is very easy.”"For us at Aenova, customers and therefore patients come first. We are delighted to be able to support the AKB together," adds Dr. Susanne Knabe, Head of Corporate Communication at Aenova.
<figure><img src="https://www.aenova-group.com/content/_medium/AKB-Scheckübergabe-4-1_EN.jpeg" data-image="567694" alt="Donation check AKB"><figcaption>Handover of the donation check from Aenova to the Bavarian Bone Marrow Donation foundation. From left: Dr. Susanne Knabe, Head of Corporate Communication at Aenova, Verena Spitzer, former patient and employee of AKB, Dr. Hans Knabe, founder and CEO of AKB. (Photo: Aenova)</figcaption></figure>

Sustainability award for exhibition stand of Aenova

21/11/2024 - Sustainability award for exhibition stand of Aenova

Starnberg, 21/11/2024

Aenova has been recognized for the sustainability of its stand at the international pharmaceutical trade fair CPHI in Milan 2024. Aenova achieved Gold status, the highest category. The main criteria of the rating are the reusability or recyclability of the exhibition stand elements, such as the flooring, lighting and furniture. Sustainability standards can also be achieved in the short-lived exhibition construction business. The use of reusable modules and systems, special LED lighting and other measures help to avoid disposable solutions, save electricity and keep transport volumes to a minimum. Aenova, one of the leading international pharmaceutical contract developers and manufacturers, has been awarded the highest "Gold" category of the "Better Stands" program for its exhibition stand at the leading trade fair for the pharmaceutical industry, CPHI 2024 in Milan. Aenova's stand featured reusable aluminum base structures, LED lighting systems and durable, reusable upholstery in the custom meeting zones. The reusable vinyl flooring panels were manufactured to fit almost exactly, reducing waste during installation. The panels were also packaged to conserve resources during packaging and shipping. "Better Stands" is a program that aims to reduce one-way exhibition stands at trade fairs in favor of reusable structures. "Our stand at this year's CPHI in Milan was very well received by visitors as an inviting and open stand with a bright and appealing design and a strong brand layout. Sustainability was very important to us in terms of structure and furnishings," explains Marie-Christin Nadzeika, the marketing expert responsible for trade fair design at Aenova.<figure><img src="https://www.aenova-group.com/content/_medium/Messestand_2024-Scribble-groß1.jpg" data-image="567580" alt="CPHI 2024 trade fair booth Aenova"><figcaption>Aenova trade fair stand at CPHI 2024 in Milan (stand layout: DEPLA Messebau)</figcaption></figure>

Aenova Statement on the Evolution of the CDMO Industry

07/11/2024 - Aenova Statement on the Evolution of the CDMO Industry

Starnberg, 07.11.2024

The current issue of the renowed magazine CHEManager International features a very interesting series of interviews on the topic "The Evolution of the CDMO Industry". More than 25 executives and industry experts give their views on how their companies are addressing the current challenges. In it, Aenova Chief Commercial Officer <a class="ql-mention" href="https://www.linkedin.com/company/5266319/admin/page-posts/published/#" data-entity-urn="urn:li:fsd_profile:ACoAAAG_gWoBRcoDhDhar2sOn6mjKuh2eiZSsdc" data-guid="2" data-object-urn="urn:li:member:29327722" data-original-text="Neil Jones" spellcheck="false" data-test-ql-mention="true" style="box-sizing: inherit; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); font-size: var(--artdeco-reset-base-font-size-hundred-percent); vertical-align: var(--artdeco-reset-base-vertical-align-baseline); background-image: ; background-position-x: ; background-position-y: ; background-size: ; background-repeat: ; background-attachment: ; background-origin: ; background-clip: ; background-color: var(--artdeco-reset-link-background-color-transparent); text-decoration: var(--artdeco-reset-link-text-decoration-none); font-weight: 600; border: var(--artdeco-reset-link-border-zero); color: var(--color-text); font-family: var(--artdeco-reset-typography-font-family-sans); touch-action: manipulation;">Neil Jones</a> shares his view on the CDMO market and highlights three key aspects of an excellent partnership between customer and CDMO partner. Aenova Chief Commercial Officer Neil Jones is among them and shares his view on the CDMO market and highlights three key aspects of an excellent partnership between customer and CDMO partner. Read <a href="https://www.chemanager-online.com/en/news/expert-statement-neil-jones-aenova">more</a>.
The evolution of the CDMO sector is propelled by rising manufacturing standards, the advent of groundbreaking therapies, and a shift towards personalized medicine.
Contract development and manufacturing organizations (CDMOs) have been on the rise in the last decade. Historically, CDMOs operated on a business model which predominantly focused on serving as external service providers for manufacturing pharmaceuticals. This model included the addition of capacity by the acquisition of manufacturing facilities from (bio)pharma companies or own capital investments. However, CDMOs have increasingly become innovation leaders and cover more areas of the pharma business, not just manufacturing, opening up additional revenue streams.
You can find the entire statement series <a href="https://www.chemanager-online.com/en/news/evolution-cdmo-industry">here</a>.

Aenova CEO Awards for outstanding value orientation

25/10/2024 - Aenova CEO Awards for outstanding value orientation

Starnberg, 25/10/2024

At the Aenova Leadership Summit this week, the CEO Awards were presented for outstanding achievements and successes in line with our five core Aenova values. The awards went to employees and their teams who embody our core values in a special way in their daily work.
Aenova is characterized by a strong corporate culture based on five core values. That is why the Aenova CEO Awards were presented for the first time this year, honouring exemplary behavior by employees and teams along these five values:
#1 Customers and patients first #2 Everyone matters #3 Excellence and reliability #4 Better every day #5 Stronger as a group A heartfelt congratulations to all the winners!
The Aenova Leadership Summit focused on best-practice presentations, departmental workshops, and networking within the Aenova Group. The program was complemented by inspiring talks with and from our customers and patients.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova-CEO-Award_2024.jpg" data-image="567249" alt="CEO Award 2024"><figcaption>The five winners together with Aenova CEO Jan Kengelbach (center)</figcaption></figure>

Aenova strengthens its development services focusing on pre-formulation and bioavailability enhancement

04/10/2024 - Aenova strengthens its development services focusing on pre-formulation and bioavailability enhancement

Starnberg, 04/10/2024

Aenova, one of the world's leading Contract Development and Manufacturing Organizations (CDMO) strengthens its development services, in particular in the areas of formulation and pre-formulation as well as clinical trial services. Thus, Aenova offers its customers an even wider range of end-to-end services in the product life cycle of a drug. The pharmaceutical development market is becoming increasingly complex, with drug discovery and biopharmaceutical companies having a portfolio of molecules that are more difficult than ever to deliver to the human body and to formulate into finished dosage forms. At the same time, with rising R&D costs and increasing pressure to deliver results, pharmaceutical companies must be able to streamline their research processes and optimize their resources. Aenova has responded to these market demands by significantly strengthening its offering in development services in order to support development programs as early as possible, even starting at the pre-clinical phase. As a trusted CDMO, Aenova´s expanded development services provide a science-driven integrated approach from pre-formulation to final formulation at minimum API consumption, as well as analytical method development. A comprehensive technology offering is now available to address the formulation and bioavailability challenges of poorly soluble drugs, including lipid-based formulations, Hot-melt extrusion (HME), spray drying, pelletization with down stream processing in tablets, capsules and low-dosed capsules for all API classes including high-potent APIs. This applies to both NCEs (new chemical entities) and generic reformulations. The range of products and services includes API characterization and formulation services, analytical development, as well as prototyping in fully GMP pilot plants that are integrated in the Aenova manufacturing sites. Aenova has decades of experience in development and offers its customers development services from six Development Centers of Excellence. Highly skilled formulation and analytical scientists bring many years of experience in all phases of the product life cycle. Aenova has also massively invested in the development and fill & finish manufacturing services of injectables in pre-filled syringes and vials. Thus, customers receive all product phases from development to large-scale production from single source and can be supported individually and flexibly according to their needs and regarding various sizes of projects. With this extension of capabilities and a wide range of patient centric dosage forms, Aenova is also targeting new patient populations in need of more patient-friendly medicines, such as children and the elderly. For instance, Aenova has specific platforms for chewable softgels, for the production of nutraceutical or pharmaceutical gummies, for effervescents, and for ODTs (orally disintegrating tablets). These dosage forms are often favored for their ease of administration and can be adapted to consumer health or nutraceutical products but also prescription products. “While CDMOs must continue to support the lifecycle of existing products and technologies, they also need to keep investing in additional capabilities to offer an even broader range of services to help pharmaceutical and biotech companies accelerate their programs and focus their resources where they can add the most value. With its extended range of development services, Aenova is in a position to support its customers in exactly this area”, explains Florent Bordet, Chief Scientific Officer at Aenova.

Aenova scales up high-potent medicines´ development and manufacturing capabilities

16/09/2024 - Aenova scales up high-potent medicines´ development and manufacturing capabilities

Regensburg, 16/09/2024

Aenova, one of the world's leading Contract Development and Manufacturing Organizations (CDMO) expands its offering for the development and manufacturing of high-potent active pharmaceutical ingredients at its Regensburg site. Aenova thus provides its customers with doubled capacities for laboratory and manufacturing and strengthened its development services for innovative APIs including pre-formulation services. Highly effective active pharmaceutical ingredients, e.g. for cancer drugs and immunosuppressants, are increasingly in demand on the global pharmaceutical market. The Aenova site in Regensburg is well prepared for this constantly growing trend. The company has invested a total of around 25 million euros to double its laboratory, development, and production capacities. The new building constructed for this purpose was officially inaugurated just last year. The Aenova site in Regensburg offers a comprehensive range of development and production equipment for production from very small quantities to scale-up for high-volume manufacturing. Up to 200,000 capsules and 500,000 tablets per hour can be produced with maximum efficiency and the highest quality standards using automated IPCs and fully automated visual inspection. Additionally, a dedicated production area for clinical material and niche oncology products allows the supply of smaller batch sizes, which is particularly beneficial for clinical phases. Aenova also offers various packaging solutions, including both bottles and blisters, meeting all global serialization and aggregation requirements. In addition, development services have been expanded, providing a science-driven integrated approach from pre-formulation to final formulation at minimum API consumption, as well as analytical method development. New technologies, such as hot melt extrusion, are used to process poor bioavailability compounds. This applies to both NCEs (new chemical entities) and generic reformulations. Highly skilled formulation and analytical scientists bring many years of experience in all phases of the product life cycle. The Aenova Regensburg site is a Competence Center for the development and production of oral solid dosage forms containing high-potency APIs. The site supplies customers in all the relevant pharmaceutical markets around the world with life-saving products. Customers receive all product phases from development to large-scale production and can be supported individually and flexibly according to their needs. "With our own GMP production and laboratory area, we not only achieve a significant increase in production volumes, but also meet all our customers' requirements for highly potent solids from a single source. This is our unique selling point," comments Oliver Schmied, Managing Director of Aenova's Regensburg site.

<figure><img src="https://www.aenova-group.com/content/_medium/20240409_Aenova_Regensburg16762.jpg" data-image="566796" alt="High containment Regensburg"><figcaption>Flexible high-containment manufacturing solutions for high-potent APIs (Photo: Aenova)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/_medium/20240409_Aenova_Regensburg15873.jpg" data-image="566793" alt="Packaging Line Regensburg"><figcaption>Flexible manufacturing and packaging solutions for high-potent APIs (Photo: Aenova)</figcaption></figure>

Closing completed: Kühne Holding is new majority shareholder of pharma contract manufacturer Aenova

30/08/2024 - Closing completed: Kühne Holding is new majority shareholder of pharma contract manufacturer Aenova

Starnberg, 30/08/2024

After a successful regulatory approvals process, the takeover of the pharma contract development and manufacturing organization Aenova by Kühne Holding AG was closed on August 29, 2024. The previous owner, the private investment company BC Partners, will support Aenova alongside Kühne Holding AG as a minority shareholder.
Aenova is one of the world's leading CDMOs (Contract Development and Manufacturing Organizations) in the pharmaceutical and healthcare industry. Headquartered in Starnberg near Munich and with around 4,000 employees at 14 production sites worldwide, the company is a full-service provider for the development, manufacturing, and packaging of drug products for pharma companies around the globe. At the end of April 2024, it was announced that Kühne Holding AG has entered into a definitive agreement to acquire Aenova from leading international investment firm BC Partners. The regulatory approvals process has been conducted over the past few months. The closing took place on August 29, 2024. "With Kühne Holding AG, we have a strong partner for the further implementation of our strategy to make Aenova the leading CDMO with flexible capacities and innovative specialty platforms. We will continue to strengthen our competitive advantage in the production of conventional dosage forms while expanding in-demand technology platforms and development services to meet the future needs of our customers and thus provide patients worldwide with our services," explains Jan Kengelbach, who has led Aenova as CEO since 2018.

Aenova expands with new gummy line for pharma and food grade

28/08/2024 - Aenova expands with new gummy line for pharma and food grade

Starnberg, 28/08/2024

Aenova, one of the world's leading CDMOs (Contract Development and Manufacturing Organizations) for the pharmaceutical and healthcare industries, is implementing a new gummy line at its site in Cornu, Romania. Gummies are quickly emerging as the dosage form of choice for many food supplements and even pharmaceutical applications. The new gummy line will be launched by the end of 2024 with a capacity of approximately 1 billion gummies per year. The global gummy supplements market has reached a value of over $ 9 billion in 2023 and is expected to grow to $ 18.2 billion by 2033. The surge in demand for gummies (chewable gels) is driven by a number of benefits related to convenience, indulgence, and efficacy. Aenova's new gummy line addresses this market with a complete, state-of-the-art production area for gummies, including bottle packaging, which has been developed with an investment of approximately € 8 million. The manufacturing process is starchless and offers food and pharmaceutical grade (GMP) production for gelatin and pectin formulations with halal, kosher, and vegan options available. Format settings can be tailored to suit a range of sizes and shapes. The new line, with a capacity of approximately one billion gummies per year, is scheduled to go live at the end of 2024. While gummies are helpful for children and anyone who has difficulty swallowing or digesting medications, adults enjoy them as well. Specialized gummy formulas can address specific needs such as immune system support, bone health, digestive issues, pain, sleep, or antioxidants. Gummies release their active ingredients when they are chewed and their flavor can mask unpleasant tastes and odors, providing a much more enjoyable experience than traditional pills. With formulas that are free of artificial colors, flavors or even sugar, they also offer vegan-friendly options that use pectin as a base, giving consumers a health-conscious choice. “Our new gummy area offers our customers a brand-new platform that will facilitate our entry into an attractive market and allow our company to gain a competitive edge in terms of experience, flexibility, and market presence. With over 40 years of experience in gelatin cooking and handling, Aenova offers excellent standards of hygiene, efficiency, and product quality”, comments Michael Ammann, Managing Director Site Cornu / Vice President Operations Softgel Capsules at the Aenova Group.

Aenova expert article on "Optimising the pre-filled syringe filling process"

31/07/2024 - Aenova expert article on "Optimising the pre-filled syringe filling process"

Latina, 31/07/2024

In recent years, the market demand for user-friendly injectable delivery systems has increased. 
The development of Prefilled Syringes (PFS) has piqued substantial interest in the industry, primarily due to its unique advantages. PFS, designed for self-administration, offers rapid injection efficiency and unparalleled dosing accuracy, making it a game changer in the field of injectable delivery systems. Among the currently available fill-and-finish technologies, peristaltic pump dosing and single-use filling assemblies have attracted attention as clean technologies that allow gentle product transfer and minimize shear stress on formulation. For this study, conducted at the Aenova Group’s Latina site in collaboration with the Pharmacy Department of “G. D’Annunzio” University (Chieti-Pescara), a custom-designed, single-use filling assembly made of ePTFE and silicon was utilized. This innovative assembly, chosen to minimize operator handling and connection in an aseptic environment, is high-temperature resistant, can be cleaned in place (CIP) and sterilized in place (SIP) and is resistant to mechanical stress with minimal spallation phenomenon. These features significantly contribute to its practicality and effectiveness in PFS manufacturing. The quality of the filling profile is critical to ensure dosing accuracy. Therefore, the study’s scope was to understand the influence of the filling line parameters and the geometry of the filling assembly on the filling profile and dosing accuracy. A design of experiments approach was applied, and a capability analysis was performed to evaluate statistical process control. An optimal combination of the best possible filling profile and filling speed sustainable for business purposes was identified, providing valuable insight into the challenges of PFS manufacturing. The results obtained by Aenova, set a benchmark for fill-and-finish manufacturing processes. They show that the configuration and type of materials identified can be a viable alternative for the production of biological injectables whose active ingredients are susceptible to gamma radiated materials or exposure to high levels of hydrogen peroxides. This finding ensures filling stability for extended production runs, providing crucial information for the industry. Aenova is a global leading Contract Development and Manufacturing Organization with a Competence Center for sterile technologies at its site in Latina, Italy.
The study on the topic "Optimizing the Prefilled Syringe Filling Process for Biological Molecules Using Innovative Single-Use Technologies: A Design of Experiments Approach" is published in the current issue of the renowned magazine “Pharmaceutical Manufacturing and Packaging Sourcer – Parenteral Technology Supplement 2024”.
With credits to: Pharmaceutical Manufacturing and Packing Sourcer, Parenteral Technology Supplement 2024, pages 37-41. © Samedan Ltd.
<a href="https://www.aenova-group.com/content/Aenova_Fill-and-Finish-study-on-optimized-filling-process_Parenteral-Tech-Supp-2024.pdf">Aenova Fill and Finish study on optimized filling process Parenteral Tech Supp 2024</a> 
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Latina_PFS.jpg" data-image="565951" alt="Aenova Latina PFS"><figcaption>Manufacturing of pre-filled syringes at the Aenova Latina site</figcaption></figure>

Aenova published Annual Report 2023: Best financial year in the company's history

05/07/2024 - Aenova published Annual Report 2023: Best financial year in the company's history

Starnberg, 05/07/2024

Starnberg, 08 July 2024 - The Aenova Group has published its annual report for 2023, which reflects the most successful business year in the history of the Aenova Group. The financial results are very strong, as the key figures for 2023 showcases at a glance:<ul><li>EUR 137 million adj. EBITDA</li><li>EUR 166 million new business wins</li><li>EUR 833 million revenue (pro forma)</li></ul>
For Aenova, the year 2023 was a record year in many respects. Revenue grew by 17% to EUR 833 m and EBITDA surged to a record level of EUR 137 m. New wins rose by 95% to EUR 166 m compared to previous year. Major new wins include originator products and a high-volume GLP-1 receptor agonist, demonstrating Aenova's strategic focus on innovative and high-potential drugs. The strategy of expanding capacities and upgrading the machine park in the established products’ business, while building differentiated technology platforms and commercializing the development projects of first-to-market generics as well as NCEs has outperformed the expectations. The outlook for the current year and the coming years is also extremely promising. With the specific focus on expanding existing technology platforms, plus the launch of new platforms, including organic spray drying, large molecule fill and finish, hot melt extrusion, low-dose capsule filling and the launch of a large-volume OTC and nutraceutical gummy platform, Aenova is positioned very well for further growth in 2024 and beyond. The Aenova Annual Report 2023 is available <a href="https://www.aenova-group.com/content/Aenova_Annual_Report_2023.pdf">here</a>.

Kirchberg

New Aenova White Paper: Softgel Capsules. A solution for poorly soluble and low bioavailability APIs

28/06/2024 - New Aenova White Paper: Softgel Capsules. A solution for poorly soluble and low bioavailability APIs

Starnberg, 28/06/2024

Low aqueous drug solubility in pharmaceutical development is a recurring issue. The softgel capsule offers many possibilities in the development of new drugs, especially when it comes to solubility and bioavailability enhancement. In the current white paper, experts from Aenova explain the challenges of softgel capsules in development and commercial production, particularly considering the complexity of softgel production technology, as well as the suitability of the softgel capsule as an appropriate dosage form for certain areas of application.
Explore the transformative potential of softgel capsule technology with the new Aenova white paper. This white paper delves into the intricacies of developing and producing softgel capsules, highlighting the advantages they provide in drug formulation, including improved stability, patient-friendly administration, and precise dosing. With insights from Aenova’s decades of expertise, learn how an experienced CDMO can be a valuable partner in unlocking alternative forms of drug delivery and driving the success of your pharmaceutical products.
Get in touch with our <a href="mailto:contact-sales@aenova-group.com?subject=New Aenova white paper Softgel Capsules" target="_blank">sales team</a> right away.
Learn more in our <a href="https://www.aenova-group.com/content/Aenova_Whitepaper_Pharmaceutical_Softgel_Capsules.pdf">white paper "Softgel Capsules. A solution for poorly soluble and low bioavailability APIs".</a>

Aenova achieves silver medal in EcoVadis sustainability rating

07/06/2024 - Aenova achieves silver medal in EcoVadis sustainability rating

Starnberg, 07/06/2024

Aenova has once again achieved silver status in the latest EcoVadis sustainability rating. The rating documents the sustainability status of the Aenova Group in the categories "Environment", "Labor and Human Rights", "Ethics" and "Sustainable Procurement". The result places Aenova in the top 15% of companies assessed by EcoVadis. Certified proof of sustainability in the areas of environment, labor, ethics and procurement is becoming increasingly important for companies and their suppliers. Approximately half of the world's leading pharmaceutical companies use the assessment of EcoVadis, one of the largest international providers of sustainability ratings, for this purpose. The Aenova Group also undergoes an annual assessment by EcoVadis. Aenova achieved significantly improved results in the area of ethics compared to the previous year. The introduction of a whistleblower system and an incident response procedure led to an increase in the rating. In the area of procurement, Aenova was able to score significantly by introducing monitoring and reporting on the Supply Chain Due Diligence Act (LkSG) for suppliers. This ensures that suppliers in Aenova's supply chain are LkSG compliant according to the current legal situation. Significant improvements have also been achieved through the implementation of the Aenova Supplier Code of Conduct and the integration of social/environmental clauses in supplier contracts. The responsible use of resources is also recognized, as the production steps in the pharmaceutical industry are energy intensive. Many Aenova sites already have photovoltaic systems to generate their own electricity. Other sites are being equipped with photovoltaic systems on an ongoing basis. The silver medal places Aenova in the top 15 percent of companies rated by EcoVadis. Approximately 130,000 companies worldwide use the EcoVadis sustainability rating. "We are very pleased with the improvement of our results in the latest EcoVadis assessment and see this as an incentive to further optimize our sustainability strategy. For example, several Aenova sites now use only renewable energy", comments Guy Ridsdill, Global Head of HSE at the Aenova Group.

Kühne Holding acquires Pharma Contract Manufacturer Aenova from BC Partners

24/04/2024 - Kühne Holding acquires Pharma Contract Manufacturer Aenova from BC Partners

Starnberg, 24/04/2024

Kühne Holding AG has entered into a definitive agreement to acquire pharma contract development and manufacturing organization Aenova Group from leading international investment firm BC Partners. As part of the transaction, BC Partners’ advised funds will reinvest alongside Kühne Holding AG and continue to support Aenova as a minority shareholder. Financial terms were not disclosed. The Aenova Group is one of the world's leading CDMOs (Contract Development and Manufacturing Organizations) in the pharmaceutical and healthcare industry. Headquartered in Starnberg, near Munich, and with approximately 4,000 employees in 14 manufacturing sites worldwide, the company is a one-stop service provider for the development, manufacturing, and packaging of drug products for pharma companies around the globe. Under the ownership of BC Partners, the Aenova Group has developed into one of the ten largest CDMOs in the world. The company’s growth trajectory has accelerated under the leadership of CEO Jan Kengelbach, who has repositioned the company into differentiated and innovative growth platforms during his six-year tenure at the helm of the Group. In 2023 Aenova has delivered record results with pro-forma revenue of €832m, an increase of 17% on prior year. The Kühne Holding AG, based in Schindellegi (Switzerland), combines Klaus-Michael Kühne’s business interests. With an entrepreneurial focus, it holds a majority stake in Kühne+Nagel International AG and is the largest single shareholder of Hapag-Lloyd AG, Deutsche Lufthansa AG and Brenntag SE. Dominik de Daniel, CEO at Kühne Holding AG, says: "With this investment, we are taking an important strategic step to enlarge our investment portfolio to include healthcare and pharmaceutical assets with a strong financial base and long-term growth prospects. Aenova is on a great performance track, and we are excited to accelerate it even further under our ownership." BC Partners’ Chairman, Raymond Svider, adds: “It has been a pleasure to partner with Jan and the entire Aenova team on this journey. Together, we have positioned the business as a global leader in contract manufacturing and built solid foundations for future growth, with the company now benefiting from strong sales momentum, a record order book, and supportive sector tailwinds. We’re pleased to see such an important German healthcare business continue its growth trajectory under the strategic ownership of Kühne Holding AG. As a firm, we have a long and successful history of partnering with families and founders across Europe, and we look forward to working closely with Kühne Holding AG and Aenova in this next chapter for the business.” Jan Kengelbach, CEO at Aenova, emphasizes: "With the new ownership structure, we will continue to implement our strategy of making Aenova the go-to CDMO with market-leading capabilities and innovative specialty technologies in Europe. With its long-term investment horizon, Kühne Holding AG is a perfect fit for the business to support this strategy. It allows us to continue down the path of operational excellence in the conventional manufacturing business, while building highly sought-after technology platforms and development services to satisfy the customer demand of the future". E3X Partners (“E3X”), in close partnership with Kühne Holding AG, drove the structuring and execution of the proposed acquisition. Martin Mix, Managing Partner at E3X, an investment and advisory firm, comments: “Our partnership with Kühne Holding AG underscores our strategic commitment to bringing together the right long-term partners for driving growth at Aenova.” Jan-Felix Stolz, Managing Partner at E3X, adds: “Aenova has high strategic relevance for a growing European pharma market, and we are enthusiastic about its prospects.” BC Partners and Aenova have been advised by Jefferies, Kirkland & Ellis, L.E.K. and PwC. Kühne Holding AG and E3X Partners have been advised by Allen & Overy and EY. The transaction is subject to customary closing conditions and approvals of the competent merger control authorities.

Anne-Sophie Bonte appointed as new Chief Quality Officer at Aenova

18/04/2024 - Anne-Sophie Bonte appointed as new Chief Quality Officer at Aenova

Starnberg, 18/04/2024

Dr Anne-Sophie Bonte has been appointed as the new Chief Quality Officer (CQO) at contract developer and manufacturer Aenova, with effect from March 01, 2024. She is also a member of the Executive Leadership Team at Aenova. In her role at Aenova, Anne-Sophie Bonte is responsible for the overall leadership, alignment and execution of the quality manufacturing programs, project management and quality processes across Aenova's production sites and corporate. "I am delighted to shape the further development of Aenova and set the strategic direction to enhance quality-manufacturing strategies, and effectively manage the associated activities and resources necessary to support and harmonize the organization’s quality aspects and business needs," comments Anne-Sophie Bonte on her start at CDMO Aenova. Anne-Sophie Bonte has many years of extensive experience in quality management in the pharmaceutical industry and the CDMO environment. She gains experience in several companies like LFB, Roche and Cenexi before moving into high-level management positions at Catalent and Galderma. She holds a PhD in Pharmacy and a Master's degree in Biological and Medical Sciences from the University of Lille as well as an MSc in Pharmaceutical Development and Industrial Production of Health Products from the Industrial Institute of Pharmacy in Bordeaux. "With Anne-Sophie Bonte, we have found an excellent Chief Quality Officer to continuously improve quality processes and thus further expand the Aenova quality structure in accordance with regulations and customer requirements," says Aenova CEO Jan Kengelbach.

Aenova wins 'Highest Innovative Strength' award

05/04/2024 - Aenova wins 'Highest Innovative Strength' award

Starnberg, 05/04/2024

Aenova has achieved the best result in the generics sector in a study on the innovative strength of German companies, making it the number one company in Germany. The study was conducted by the renowned German newspaper Die WELT in cooperation with the Cologne-based analysis institute ServiceValue. In the online survey, more than 200,000 managers were asked about the innovative strength of 2,350 German companies from various sectors. The survey focused on the company- or market-related innovative strength of the strategies and concepts of the companies assessed, as well as the impetus that the respective company gives to the market. Aenova was awarded "Highest Innovative Strength" in the pharmaceuticals/generics sector, taking first place in Germany ahead of large, well-known competitors in the generics market. Aenova's strategy is increasingly focused on innovation, for example in the development of special technologies and development offerings for generics as well as for patent-protected drugs. Even in the generics sector, drugs that are no longer protected by patents can be innovatively developed further, for example to improve patient convenience with a modified dosage form. One example is the reformulation of a tablet into an orodispersible tablet (ODT), which simply dissolves in the mouth - a growth market that is becoming increasingly important in view of the aging population. At the same time, Aenova continues to invest heavily in highly efficient and semi-automated production capacity for high-volume generics in order to reliably meet the demands of the market. However, Aenova is also expanding its range of differentiated technologies beyond the generics portfolio. In the area of special technologies for new drugs, the company is focusing on the expansion of innovative platforms for improving the bioavailability of active ingredients (e.g. hot melt extrusion, spray drying, softgel capsules), micro-dosed capsules, fill & finish of injectable drugs, high potency drugs, particularly in the field of oncology, and blockbuster products. With its broad range of services, Aenova offers its customers the added value of end-to-end services from development to commercial production for all common dosage forms and thus plays a key role in the global supply of medicines. "The award for "Highest Innovative Strength" honors our strategy of sophisticated development services and innovative special technologies combined with outstanding production capacities. Our goal is to provide our customers, and thus patients worldwide, with their medicines reliably and in the highest quality," explains Jan Kengelbach, CEO of Aenova. "This applies to both high-volume generics and originator products, such as diabetes and cancer medicines. Aenova is characterized by a broad, innovative product range that can respond flexibly to increased market demand. Here you can find out more about the overall results of the study and the study design (in German) <a href="https://servicevalue.de/rankings/generika-10/">https://servicevalue.de/rankings/generika-10/</a><a href="https://servicevalue.de/rankings/generika-10/"></a>
<figure><img src="https://www.aenova-group.com/content/Siegel_Innovationskraft_2024_HÖCHSTE_Aenova.jpg" data-image="562002" alt="Siegel Höchste Innovationskraft"><figcaption>Among German pharmaceutical/generics companies, Aenova was recognized as having the highest innovative strength.</figcaption></figure>

Aenova supports Heimstätten Wil foundation with a donation of 2,000.00 euros

04/04/2024 - Aenova supports Heimstätten Wil foundation with a donation of 2,000.00 euros

Kirchberg, 04/04/2024

Aenova presented the Heimstätten Wil Foundation with a cheque for 2,000.00 euros on April 3, 2024. The idea for the donation campaign was born at the Aenova Corporate Sales Meeting, which took place at the Aenova site in Kirchberg (SG), Switzerland, in February. The company already has a long-standing partnership with the Heimstätten Wil foundation. The Heimstätten Wil Foundation offers living and working spaces for around 400 adults with disabilities. The services are geared towards their individual needs and requirements. External jobs are also offered in cooperation with companies in the primary labor market. Around 160 specialists, apprentices and interns work at the foundation. The Aenova site in Kirchberg has been working with the Heimstätten Wil foundation since the pandemic. Back then, the pharmaceutical company commissioned the foundation to assemble Christmas hampers for its employees. Aenova develops, produces and packages soft gelatine capsules in Kirchberg for the pharmaceutical and healthcare industry, helping patients all over the world to lead healthier lives. More than two billion capsules leave the factory every year and are sold in over 100 countries worldwide, including Europe, the USA and China. The site also fills softgel capsules with highly effective active ingredients in extremely low dosages, where the proverbial Swiss precision is required. Around 170 employees contribute to the success of the company in Kirchberg. "I am very pleased with the decision to donate to an organization in our immediate neighbourhood. We would like to make a contribution to the valuable work of the Heimstätten Wil Foundation," explains Dr. Christian Luftensteiner, Managing Director at the Aenova site in Kirchberg. "Thank you to the Aenova Corporate Sales employees for their generous donation! Every bit of support helps us to get closer to our vision of an inclusive society," says Arlette A. Hippmann, Head of Communications, Heimstätten Wil Foundation.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Stiftung-Heimstaetten-Wil-Scheckuebergabe_11.JPG" data-image="561988" alt="Scheckübergabe Wil"><figcaption>Presentation of the Aenova donation check to the Heimstätten Wil Foundation. From left to right: Dr. Christian Luftensteiner, Managing Director of SWISS CAPS AG, Arlette Hippmann, Head of Communications at the Heimstätten Wil Foundation, Thomas Kleeberg, Vice President Business Management, Aenova (Photo: Daniel Müller, employee of the development workshop, Heimstätten Wil Foundation)</figcaption></figure>

OSD outsourcing: challenges and approaches to solutions (article "Contract Pharma")

15/03/2024 - OSD outsourcing: challenges and approaches to solutions ("Contract Pharma" article)

Starnberg, 15/03/2024

The challenges of the current OSD outsourcing market are explained in an excellent editorial overview article in the current issue of the specialist magazine "Contract Pharma".
The article deals not only with contract manufacturing of complex new active pharmaceutical ingredients, but also with aspects of production capacity.
Aenova Chief Commercial Officer Neil Jones and Aenova Chief Scientific Officer Florent Bordet, among others, provide information on current market trends, challenges such as the bioavailability of active ingredients and explain possible solutions. 
Just recently, Aenova reported on major investments for capacity expansions at the high-volume site for conventional solids at the Tittmoning site and emphasized its capabilities in the area of innovative technologies and solutions.
Read more in the current issue of <a href="https://www.contractpharma.com/issues/2024-03-01/view_features/osd-outsourcing-savvy-cmos-hone-skills-as-complex-apis-fuel-demand/?widget=listSection" target="_blank">"Contract Pharma" magazine.</a>
Learn more about the<a href="https://www.aenova-group.com/en/news-events/news/05-12-2023-huge-capacity-increase-at-tittmoning-site"> capacity expansions at the high-volume site for conventional solids </a>at the Tittmoning site and highlighted Aenova's <a href="https://www.aenova-group.com/en/news-events/news/15-09-2023-innovation-is-key-how-cdmos-can-contribute-to-pharma-supply-even-better">capabilities in the area of innovative technologies </a>and solutions.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Tittmoning_Expansion_kl.jpg" data-image="560308" alt="Tittmoning Contract Pharma"><figcaption>State-of-the-art, high-volume solids production at the Aenova site in Tittmoning (Photo: Aenova)</figcaption></figure>

New white paper from Aenova: "Faster time to market for pharmaceuticals using capsule low-dosing technology"

29/02/2024 - New white paper from Aenova: "Faster time to market for pharmaceuticals using capsule low-dosing technology"

Starnberg, 29/02/2024

One of the biggest challenges in pharmaceutical research and development is to complete development projects as quickly as possible. More and more drugs fall into the category of 'unmet medical need' and therefore qualify for accelerated approval. But developers need time to optimise the formulation of the sensitive or highly potent compounds that dominate the current pipeline of drug candidates. Finding the right balance between speed and thoroughness is a challenge. But it can be solved by choosing microdosing technology in capsules. Manufacturers can dose small amounts of pure active pharmaceutical ingredients (APIs) or mixtures directly into hard capsules. Microdosing of less than 5 mg or low doses of 5 mg to 100 mg in hard capsules is a good option that allows manufacturers to get new drugs into research and development or onto the market faster. The direct, precise and reliable filling of low-dose hard capsules can be scaled up in an industrial process. This means that processes developed for initial studies can be used for commercial production, eliminating some study and development work and bringing a drug to market faster. Learn more about low-dose capsule technology in Aenova's white paper "Accelerating drug product launches using low-dose capsule technology" in collaboration with the renowned expert platform c&en of the American Chemical Society (ACS). The Aenova sales team will be happy to advise you if you have any questions. Please contact us <a href="mailto:contact-sales@aenova-group.com?subject=Request regarding low-dosed capsule technology" target="_blank">here</a>.
You can download the white paper directly here: <a href="https://www.aenova-group.com/content/resources/Aenova_cen_Whitepaper_Accelerating-pharmaceuticals-time-to-market-applications-of-capsule-low-dosing-technology.pdf">Aenova c&en Whitepaper Accelerating pharmaceuticals´ time to market: applications of capsule low-dosing technology</a>
<figure><img src="https://www.aenova-group.com/content/_medium/3-Kapseln.jpg" data-image="561549" alt="Low-dosed Hartkapseln"><figcaption>Standard hard-shell capsules can be precisely filled with low- or microdoses of an active pharmaceutical ingredient (Photo: Aenova)</figcaption></figure>

Aenova Christmas campaigns: Employees donate to social organisations

18/01/2024 - Aenova Christmas campaigns: Employees donate to social organisations

Starnberg and Tittmoning, 18/01/2024

Once again this year, Aenova organized an internal fundraiser to benefit socially disadvantaged people. Aenova employees at the Aenova headquarters in Starnberg donated winter clothing and winter shoes to a local social institution in December 2023. Many charitable organizations are reporting a decline in donations. This affects disadvantaged and socially disadvantaged people in particular. This makes it all the more important for a charitable organization to be a reliable donation partner. "It is a central concern of ours to support people in need and the socially disadvantaged. A big thank you to our employees who made this joint campaign possible again this year," explains Dr. Susanne Knabe, Head of Corporate Communication at Aenova. The donations in kind were handed over to the facility on January 16, 2024.
At the 2023 summer party at the Aenova site in Tittmoning, there was a raffle with the aim of donating the proceeds to social causes. Apprentices at the site organized the raffle and a large number of employees took part in buying raffle tickets. In December 2023, the donation was handed over to the association "Mia fia Eich e.V" ("We for you"), which supports various social organizations in the south-east of Bavaria. "We can't make the world a better place, but we can make our environment a better world". Under this motto, the association Mia fia Eich e.V., based in Traunstein, has set itself the goal of making a positive and active contribution to daily coexistence through many small good deeds. The Aenova site in Tittmoning regularly supports the "Mia fia Eich e.V." association. As part of its corporate social responsibility strategy, the Aenova Group with its 15 locations worldwide is primarily involved in the local environment and supports charitable initiatives at the individual production sites and at headquarters.<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Christmas-Charity_2023_double.jpg" data-image="560489" alt="Aenova Charity"><figcaption>left: The treasurer of the association "Mia fia Eich e.V" ("We for you") and the youth trainee representative of Aenova Tittmoning at the donation check handover; right: Tim Bauer, Chief People Officer, and Dr Susanne Knabe, Head of Corporate Communication, before transferring the donations to the recipient organization </figcaption></figure>

Tittmoning

Capacity increases for around 20 million euros: Aenova further expands its high-volume solids site in Tittmoning

05/12/2023 -Capacity increases for around 20 million euros: Aenova further expands its high-volume solids site in Tittmoning

Tittmoning, 04/12/2023

The Aenova Group is one of the world's leading contract manufacturers and development service providers for the pharmaceutical and healthcare industry. Within the Aenova Group, the Tittmoning site is the largest plant for solid oral dosage forms with a capacity of around 10 billion tablets and capsules per year. Due to consistently high demand, Aenova is continuing to invest in this site. In the coming months, four high-speed packaging lines will be installed there at a cost of around EUR 10 million, as well as an additional bulk production line for large-volume preparations with a further investment of EUR 10 million. The market demand for conventional oral solids - tablets, film-coated tablets and hard capsules - is constantly increasing. For this reason, extensive expansion projects have already been realised at the Aenova site in Tittmoning in recent years. A new production building with a total area of 3,100 square meters was put into operation in 2022. The investments made, including new bulk and packaging lines, amounted to a total of around EUR 35 million and aimed to increase capacity by 2 to 3 billion packaged tablets in the final expansion stage. In this context, the new investment projects amounting to around EUR 20 million will increase packaging capacity by around 100 million to a total of 400 million blisters and bulk capacity by almost 1 billion tablets per year. "The additional systems in the bulk production area follow the proven principle of semi-continuous production and the new high-performance packaging lines have fully automated end-of-line packaging. The higher degree of automation not only brings economic benefits, but also supports our product and service quality. At the same time, the investments will create around 50 new, state-of-the-art jobs in the region," explains Dr Helmut Stibich, Managing Director at the Tittmoning site. The first high-speed packaging line will go into operation at the end of 2023, with an almost identical line expected to go into operation in the third quarter of 2024; two further lines will be installed by the first quarter of 2025. A new, fourth production line for large-volume bulk products is to be added by the end of 2024. "With these investments, Aenova is consistently continuing its growth course and consolidating its leading position among the production facilities for conventional solids in Europe at the Tittmoning site. This is an important step towards offering our customers delivery times in line with the market and ensuring patient care," comments Jan Kengelbach, CEO of the Aenova Group.
<figure><img src="https://www.aenova-group.com/content/company/sites/tittmoning/_medium/High_volume_bulk_manufacturing_line_Tittmoning_Aenova.jpg" data-image="559052" alt="Ausbau Tittmoning"><figcaption>Further capacity increases at the Solida site in Tittmoning</figcaption></figure>

Joint Audit Initiative Annual Meeting 2023

24/11/2023 - Joint Audit Initiative Annual Meeting 2023

Starnberg, 24/11/2023

This year, the annual meeting of the JAV (Joint Audit Initiative) was held in Iserlohn, North Rhein-Westphalia, from 24 to 25 October 2023. The "Joint Audit Initiative - JAV" is an organization, with the purpose to provide the partners with audit reports on supplier qualification. A few years ago, some of the leading pharmaceutical companies in Germany made the decision to perform joint supplier audits. Also the Aenova Group is member of the joint initiative. Different companies from pharmaceutical environment, no matter if partners or competitors, big players, or smaller companies, are participating with mutual respect and understanding in a cooperative and expert-wise auditing collaboration. This activity is reducing time, personnel effort, and budget for both: auditors and supplier of materials. All these companies are united through a common GMP practice and development. Each company brings in the auditing process their local auditors which are locally certified under own policies following the same principles of the QMS (Quality Management System). On the top of that, JAV itself underlines a set of rules to be followed internally by its members so the actual implementation of this joint initiative is guided in a centralized way. The JAV Annual General Meeting brings all member companies together once a year to discuss current topics and promote mutual exchange. The Aenova Group was represented by Mirela Pop, Corporate Quality Manager. At Aenova, membership of the Joint Audit Initiative also stands for high quality standards, commitment to customer excellence and outstanding supplier management.A different member company hosts the annual meeting each year. In 2019, the annual meeting took place at the headquarters of the Aenova Group in Starnberg near Munich. Good interactions, successful collaboration and innovative solutions - that is what characterises these meetings, as well as other successful audits.
<figure><img src="https://www.aenova-group.com/content/_medium/JAV-2023.jpg" data-image="560088" alt="JAV 2023"><figcaption>Aenova ambassador Mirela Pop, Corporate Quality Manager, at JAV 2023.</figcaption></figure>

National Future Day in Kirchberg SG

16/11/2023 - National Future Day at Kirchberg SG site

Kirchberg, 16/11/2023

This year's National Future Day took place in Switzerland on November 9. 12 girls and boys left the classroom and immersed themselves in the world of work at our Kirchberg SG site for a day. A change of scene that turned into a big "working day" for our young guests. The schoolchildren were given many insights into a wide variety of professions at our Kirchberg site: in the laboratory, the workshop, production, the high-bay warehouse and the offices. Under expert guidance, they were able to carry out their own color experiments in the laboratory, "cook" gelatine in the large production kitchen and process it with rubber gloves, weld little men and name tags in the workshop and climb onto a large forklift truck in the high-bay warehouse - all this and much more was offered to the children on Future Day. Around 2,500 companies, organizations, vocational schools and universities gave interested schoolchildren an insight into gender-atypical fields of work on Future Day 2023. This allows girls and boys to look at their professional future without rigid gender stereotypes.The Aenova site in Kirchberg is a competence center for the development and production of soft gelatine capsules.
<figure><img src="https://www.aenova-group.com/content/_medium/Nat_Zukunftstag_KIR_2023.jpg" data-image="560048" alt="Nationaler Zukunftstag Kirchberg 2023"><figcaption>Pupils learn about professions regardless of gender on National Future Day</figcaption></figure>

The central role of contract manufacturers in pharmaceutical supply

31/10/2023 - The central role of contract manufacturers in pharmaceutical supply

Starnberg, 31/10/2023

<h5>How CDMOs help ensure the supply of medicines</h5>
Contract manufacturers have a pivotal role in drug supply worldwide, and the trend toward outsourcing continues unabated. Reasons for this include expiring patents on small molecule drugs, the increasing number of small molecules in clinical trials, the rise in chronic and age-related diseases, and the rapidly growing oncology market. At Aenova Group, one of the world's leading CDMOs (Contract Development and Manufacturing Organization) with around 4,000 employees worldwide, there is a significant increase in demand across all dosage forms and therapeutic areas, partly due to post-corona conditions. In this context, it is challenging to install all the necessary capacities, machines and staff, in a timely manner, as equipment manufacturers have long lead times and additional staff often have to be found.
Aenova is driving a growth strategy with massive investments for each site, either to expand existing capacity or to expand the range of innovative technologies. In total, there are 14 new growth platforms at Aenova, eight of which are already commercially active.
<h5>Capacity expansions to meet increased demand</h5>
A few examples illustrate this strategy: the Aenova high-volume site in Tittmoning, Germany, has been expanded to a production capacity of ten billion tablets per year, and four new blister lines with significantly increased capacity will start there by the end of 2025. At the Latina site in Italy, a brand new sterile filling and finishing area (incl. biologics) for prefilled syringes and RTU vials was created. Follow-up investments of around EUR 15 million are currently underway there to increase capacity for prefilled syringes (PFS). In Carugate, Italy, production capacities for the manufacture of semisolids and non-sterile liquids have been expanded with an investment of around EUR 10 million. At the Regensburg site, the new building for the development and production of highly active pharmaceutical ingredients (up to OEB 5) was opened in June 2023, a total investment of around EUR 25 million. Capacities for effervescent products will be almost doubled at the Bad Aibling site by 2025. Aenova is investing significantly in expanding production in the area of all common dosage forms.
<h5>Innovative technologies for novel therapies</h5>
The development of new drugs for a wide range of therapeutic areas is a steadily growing market and is progressing rapidly. Therefore, a smart innovation strategy is essential for contract developers and manufacturers.A CDMO should actively support customers with innovative approaches already during development services. At Aenova, there are currently various initiatives for differentiated technologies, which are primarily aimed at patient-friendly forms of therapy based on complex therapeutic systems and improved bioavailability of active ingredients.
Read more in the current issue of <a href="https://www.chemanager-online.com/produkte/wie-cdmos-zur-sicherung-der-medikamentenversorgung-beitragen" target="_blank">CHEManager 10/2023</a> (in German).

02.12.2025

Aenova at BioFIT 2025 in Strasbourg

Strasbourg, 02/12/2025