News & Events

Find out about the latest news from the Aenova Group and stay up-to-date on press releases and opportunities to meet our experts.

News & Events - Aenova Group

News - Aenova Group

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Kirchberg

Open House at Aenova Kirchberg site

19/09/2023 - Open House at Aenova Kirchberg site

Kirchberg, 19/09/2023

Aenova Kirchberg site produces highly potent drug products for the international pharmaceutical market. As one of the major employers in the region, the Aenova site opened its doors to the public on Saturday, September 16, 2023. There were guided tours of the laboratories and production; a festive restaurant with entertainment and a children's fun event rounded off the program of events. Around 1,000 interested guests visited the open day. The Aenova site in Kirchberg (SG), Switzerland, SWISS CAPS AG, develops and produces softgelatine capsules for the pharmaceutical industry, helping patients around the world to lead healthier lives. More than two billion capsules leave the factory every year and are distributed in over 100 countries worldwide, including Europe, the USA and China. In Kirchberg, softgel capsules are also filled with highly potent active ingredients in the lowest possible dosage, where the proverbial Swiss precision is required. Currently, a high-tech tropical blister line is being commissioned for such a new product to protect the drug even in extreme climatic conditions. Aenova is also investing heavily in sustainability in Kirchberg; with solar modules on flat roofs and carports, the site aims to generate more than 400,000 kWh of solar power annually itself in the future. Around 170 employees contribute to the success of the site. At the open day on September 16, 2023, interested parties from all over the region were able to take a look at the exciting world of pharmaceutical production. Around 1,000 visitors took the opportunity to look behind the scenes of the development and production of medicines "Made in Switzerland". During various plant tours, SWISS CAPS AG employees provided information on all questions. Visitors were also treated not only to food and drink stands, but also to entertainment provided by the Altoberndorf music band and the Gähwil male voice choir. For the children, fun was organized with the Jungwacht and Blauring Kirchberg, and there was a raffle with attractive prizes. "As one of the largest employers in the region, it was a great pleasure for us to give visitors a glimpse into the highly regulated world of pharmaceutical manufacturing. It's not something that happens every day. I would like to thank all those involved and, of course, all the interested guests," explains Dr. Christian Luftensteiner, Managing Director of Aenova's Kirchberg site.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_TOFT_Kirchberg_Labor.jpg" data-image="559361" alt="Im Labor Kirchberg beim Tag der Offenen Tür"><figcaption>In the laboratory: Experts explain the activities in the laboratory to members of the Kirchberg municipal council (Photo: Aenova)</figcaption></figure>

Innovation is key. How CDMOs Can Contribute to Pharma Supply even Better

15/09/2023 - Innovation is key. How CDMOs Can Contribute to Pharma Supply even Better

Starnberg, 15/09/2023

In this special article, Aenova shows how important it is to keep your finger on the pulse with innovations. This enables CDMOs to partner with their customers from development through to commercial production and also provide early-stage support for innovative medicines. Aenova expert Dr. Klaus Pollinger, Head of Manufacturing Science & Technology at Aenova, will use various examples to show how CDMOs can help their customers with the rapidly increasing demand for novel drugs and full R&D pipelines. Read more in the special article in the current issue of <a href="https://www.chemanager-online.com/en/news/how-cdmos-can-contribute-pharma-supply-even-better" target="_blank">CHEManager International 3/2023</a>.<figure><img src="https://www.aenova-group.com/content/_medium/Article_Chem_092023.jpg" data-image="559330" alt="CDMO Aenova CHEManager 2023"><figcaption>From development to commercial supply. Full services with CDMO Aenova (Photos: Aenova)</figcaption></figure>

24 trainees start the new training year at the Aenova Group

08/09/2023 - 24 trainees start the new training year at the Aenova Group

Starnberg, 08/09/2023

The new training year is starting!
We welcome our 24 new trainees at the Aenova locations and wish them a good start into a varied and interesting training at Aenova!
Whether as
<ul><li>pharmacist or chemical laboratory assistant,</li><li>machine and plant operator,</li><li>industrial mechanic or warehouse logistics specialist,</li><li>industrial clerk or mechatronics technician ( all f/m/d):</li></ul>
our sites have received several awards as outstanding training companies, often with the best apprentices at the end of the year. Good luck to you all!
 
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Trainees_2023.jpg" data-image="559197" alt="Aenova Trainees 2023"><figcaption>Some of the new trainees at Aenova Group</figcaption></figure>

New Aenova white paper in cooperation with c&en on "Development of highly potent medicines”

10/08/2023 - New Aenova white paper in cooperation with c&en on "Development of highly potent medicines”

Starnberg, 10/08/2023

HPAPIs (highly potent active pharmaceutical ingredients), provide precision treatment for cancer, autoimmune disorders, infectious diseases, and other medical conditions. Their safe handling is a challenge for drug manufacturers, who have to meet equipment, environmental and product quality requirements in the production and development of HPAPIs. HPAPIs represent one of the fastest-growing market segments in the global pharmaceutical industry. Aenova, as one of the world's leading CDMOs (Contract Development and Manufacturing Organization), offers its customers state-of-the-art facilities covering the complete life cycle from development to commercial supply with high flexibility and scalability. In collaboration with the renowned expert portal c&en, journal of the American Chemical Society, Aenova has now created a white paper specifically on the topic of how to challenge the increasing requirements in the production of HPAPIs by partnerships. Title of the whitepaper is "Supporting Development of Highly Potent Medicines with Manufacturing Flexibility”. CDMOs incorporating HPAPIs in their processes must take precautions at every step from development to production. This white paper describes e.g. the sophisticated production facilities, including isolators to contain material, personal protective equipment, and designated rooms with advanced air-handling-systems. The Aenova experts explain processing protocols and containment processes at the Aenova sites and point out how to achieve flexible, agile manufacturing coupled with operator safety and product quality. Aenova offers its customers a full service portfolio for high potent solids technologies (oncology, hormone therapy, immunomodulating therapy) from development to commercial production. 
The white paper "Supporting Development of Highly Potent Medicines with Manufacturing Flexibility” can be downloaded free of charge <a href="https://www.aenova-group.com/content/resources/Aenova_cen_Whitepaper_Development_HiPo_Drug_Products.pdf" target="_blank">under this link</a>.<figure><img src="https://www.aenova-group.com/content/news/_medium/Format_Change_high-potent_tablet-production.jpg" data-image="558670" alt="Format Change high-potent production"><figcaption>Format change, production of high-potent medicines</figcaption></figure>

Starnberg

The Aenova Group publishes Annual Report 2022

01/08/2023 - The Aenova Group publishes Annual Report 2022

Starnberg, 01/08/2023

The Aenova Group publishes its 2022 Annual Report today. The key figures 2022 of Aenova at a glance:
<ul><li>€ 749 million Net Sales 2022</li><li>€ 107 million adjusted EBITDA</li><li>+ 22% Order book</li></ul>
"We continued to expand our capacities to allow for future growth and continue to grow our technology offering to increase our competitiveness in the market," said Jan Kengelbach, CEO of Aenova Group. "We inaugurated a full new aseptic manufacturing facility for high-speed PFS and vial filling including large molecule fill and finish. Our new high-speed, large volume solid plant expansion in Tittmoning went online, and we continued to build our expansions in Kirchberg for softgel capsule packaging. We made good progress in Carugate building a high-speed liquids and semi-solid manufacturing or in Regensburg establishing a future high-potent manufacturing to come online in 2024 and 2025 respectively. This strategy of capacity expansion and capability extension through the introduction of new technologies and superior development service offering continues to serve us very well”, Jan Kengelbach added. Despite an increased revenue by +7.5% from EUR 697 m to EUR 749 m, the EBITDA declined from EUR 107 m to EUR 97 m by 9%. Future perimeter adjusted for the closure of the site in Wolfratshausen, the business grew by 10% from EUR 651 m to EUR 714 m, while EBITDA declined by 2% from EUR 104 m to EUR 102 m. Learn more about Aenova's 2022 achievements and milestones, as well as key events in each business unit.
Read <a href="https://www.aenova-group.com/content/Aenova_Annual_Report_2022.pdf">more</a>.

Latina

Aenova Latina site and Edison Next strengthen partnership by continuing the energy transition

27/07/2023 - Aenova Latina and Edison Next strengthen partnership

Milan / Latina, 27/07/2023

<h5>New photovoltaic plant of more than 1 MW</h5>
Edison Next, an Edison Group company that accompanies customers and territories on their path to decarbonization and energy transition, and Haupt Pharma Latina, member of the Aenova Group, that is among the world leaders in the pharmaceutical field, take another important step along the road to decarbonization of the Borgo San Michele production site in Latina, which, with 600 employees and 40,000 square meters of floor space, is one of the largest in the entire Aenova Group and is located in an area considered the pharmaceutical hub of Lazio. Specifically, Edison Next, under a 15-year contract signed with Aenova, will be responsible for the design, installation, maintenance and operation of a new 1.135 MW solar tracking photovoltaic plant to be installed on the ground within the production perimeter of the Latina site. The plant, which will be commissioned by the end of the year, will be capable of producing more than 2,000 MWh per year. The new photovoltaic plant, built under a PPA (Power Purchase Agreement) formula, will have an area covering about 4,800 square meters and will consist of 10 inverters and more than 1,800 modules, mounted on solar tracking support structures with a north-south orientation. "The construction of this photovoltaic plant represents a further step in the path begun a few years ago together with Aenova with the aim of improving the sustainability and energy autonomy of the Latina site," says Marco Steardo Director of Industry at Edison Next. "Photovoltaics represent a strategic resource for the energy transition of companies. It is a well-established and mature technology that can ensure immediate benefits in terms of, both environmental impact and energy cost reduction. In fact, self-producing renewable energy also means increasing one's independence from the grid by decreasing one's exposure to price volatility." "Environmental sustainability combined with economic levers are the key to our future, as a company, as a relationship with our territory. We have a responsibility to improve year after year and to look to future generations," says Paolo Abbate, managing director of Haupt Pharma Latina, member of the Aenova Group. "The partnership with Edison Next is a virtuous example of how common goals can make Europe and our customers create synergies and bring competitiveness. It is a positive model to be replicated on many other challenges of innovation and technological improvement." The share of self-consumption of renewable electricity produced by the photovoltaic system built by Edison Next will be about 80%. The remaining portion that is not self-consumed will be fed into the grid. This plant represents a new piece in the journey that Edison Next and Aenova began together almost a decade ago with the goal of increasing energy independence and decreasing the environmental impact of the Latina site. This photovoltaic plant will make it possible to meet 23 percent of the plant's electricity needs, taken to date from the grid, through renewable sources and, adding to other energy solutions already implemented by Edison Next, will make it possible by the end of the year to meet a substantial portion of the site's energy needs through self-generation. The result will be an estimated reduction in atmospheric emissions of 746 tons of CO2 per year.(1) (1) Total avoided emissions are equal to the difference between emissions for thermoelectric production from fossil sources and emissions for production from photovoltaics (equal to 0). Emissions from thermoelectric production are calculated by multiplying the expected electricity production by the emission factor of the Italian thermoelectric fleet as defined in ISPRA environmental reports.
<figure><img src="https://www.aenova-group.com/content/news/_medium/Aenova_Latina_Site.jpg" data-image="558218" alt="Aenova Latina site in Italy"><figcaption>Aenova Latina site in Italy (Photo: Aenova)</figcaption></figure>

Innovative drug formulations make medicines more patient-friendly: Aenova and Galvita enter strategic partnership

13/07/2023 - Aenova and Galvita enter strategic partnership

Starnberg / Basel, 13/07/2023

The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industry. As a full service provider, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes from pharmaceuticals to dietary supplements for human and animal health. Galvita is an innovative Swiss start-up company specializing in the development of patient-friendly, age-appropriate dosage forms.
Aenova and Galvita have entered into a strategic partnership effective July 1, 2023. The aim of the partnership is to improve the development, formulation and production of oral dosage forms. To this end, Galvita brings knowledge of specific child- and senior-friendly formulations that feature faster oral disintegration, better taste masking and higher drug loading than oral dosage forms currently available on the market. Galvita's revolutionary and patented Templated-Inverted Particles (TIP) technology consists of clinically tested calcium-phosphate microcapsules that can be loaded with a wide variety of active ingredients via a self-loading mechanism. The capsules are then processed into tablets. These tablets have the property of disintegrating almost instantly upon ingestion, releasing the active ingredient. Patients with swallowing disorders (dysphagia) can thus be supplied effortlessly. Another advantage is taste masking of active ingredients. This technology thus increases acceptance and adherence to therapy, especially among special patient groups such as children and the elderly. Above all, it offers an alternative to intramuscular injection in many cases. As a broad-based CDMO (Contract Development and Manufacturing Organization), Aenova brings many years of expertise, extensive GMP knowledge, international resources, rapid scalability and effective market access for the technology to the partnership. As Galvita's strategic industrial CDMO partner, Aenova will offer this technology for customer projects at its site in Sisseln, Switzerland. Aenova's Sisseln site is the Competence Center for complex solids within the Aenova network and develops and produces innovative, customized solutions for oral solid dosage forms. The two managing directors of the new partners, Jan Kengelbach, CEO of Aenova Group, which is the industry partner of the cooperation, and Dr. Roland Haag, co-founder and CEO of Galvita, agree: "The portfolio and the experience and knowledge of the individual companies complement each other perfectly in order to be able to offer an almost unique added value even faster for our customers and, above all, for patients worldwide." 
<figure><img src="https://www.aenova-group.com/content/news/_medium/Mikroskopaufnahme-TIP-Galvita.png" data-image="558089" alt="TIP Galvita"><figcaption>Close-up of a TIP microcapsule that can be loaded with a wide variety of active ingredients (Photo: Galvita)</figcaption></figure><figure><img src="https://www.aenova-group.com/content/news/_medium/Tablettenherstellung-Sisseln.jpg" data-image="558096" alt="Tablettenherstellung Sisseln"><figcaption>Tablet production at Aenova's Sisseln site (Photo: Aenova)</figcaption></figure>

Regensburg

Aenova opens new building for the production of highly potent drugs at the Regensburg site

23/06/2023 - Aenova opens new building for the production of highly potent drugs at the Regensburg site

Regensburg, 23/06/2023

Aenova opened its new building for highly potent active ingredients at the Regensburg site on June 22, 2023. Highly potent drugs against cancer, among other things, are produced in the new production facilities. With a total investment of around 25 million euros at the Regensburg site, Aenova will thus be able to significantly increase its development and production capacities for the increased market demand for highly effective drugs.
Cytotoxics and cytostatics are in increased demand in the global pharmaceutical market. To meet this steadily increasing demand, Aenova, the world's leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, has built a new building at its Regensburg site for the development and production of highly effective active pharmaceutical ingredients. The total investment of around €25 million will enable the company to significantly expand its production of highly potent active ingredients up to OEB 5 and, in particular, of cancer drugs. The new building was opened on June 22, 2023. The Aenova site in Regensburg has been developing and producing tablets and capsules with highly potent active ingredients such as methotrexate, hydroxycarbamide, azathioprine, imatinib since the 1950s. These are, for example, drugs for the treatment of inflammatory diseases such as psiorasis or arthritis, against autoimmune diseases, drugs against cancer such as leukemia, but also novel drugs (so-called New Chemical Entities, NCE). The special feature of many of these drugs is their high efficacy, which means that the active ingredients already have the desired effect in the smallest doses, but special safety standards must therefore also be observed during development and production. The new four-story building with a total building area of more than 4,000 m² houses the production and packaging of highly potent tablets as well as the associated laboratories, development, storage and social rooms. This means a significant expansion of the production area and the areas of development and laboratory by over 2,100 m² at the Regensburg site. After the planned start-up at the beginning of 2024, the production capacities can thus be increased in volume by significantly more than 1 billion tablets and capsules. An entire floor is reserved for flexible customer requests for "on demand" production, so that existing and new customers can be individually supported in line with their requests. The new building is part of the strategic profiling of the Regensburg site for the development and production of highly effective medicines. Around 400 people are employed at the Regensburg site. The Regensburg site is "Competence Center HPAPI & Oncology Products" within the Aenova Group with leading HPAPI development, production and packaging facilities for high-potent solids. “The new building is an important milestone for this," explains Oliver Schmied, Managing Director at the Aenova site in Regensburg. “Producing billions of tablets and capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing. A particularly unique selling point is that we offer production flexibility using harmonized production equipment, enabling small to large batches from 0.5 to 500kg for development, CTM, scale up and commercial batches," continues Oliver Schmied. "Within the overall investments of the Aenova Group, the new building for highly potent APIs in Regensburg is an essential strategic building block. As a development and manufacturing partner, we are thus a reliable and agile CDMO (Contract Development & Manufacturing Organization) for our customers in the promising market segment of highly potent active ingredients," comments Jan Kengelbach, CEO of the Aenova Group. With the new building, Aenova will not only be able to better serve market needs and customer requests in the future, but above all reliably provide vital medicines for patients with cancer worldwide. In the next few months, the laboratories and the new "on-demand" GMP area will be set up. Customer orders can go into production from 2024.
<figure><img src="https://www.aenova-group.com/content/news/_medium/Aenova-Regensburg_Opening-Ceremony.jpg" data-image="557849" alt="Ceremony Regensburg"><figcaption>Ceremonial opening of the new building for highly effective pharmaceuticals at the Aenova site in Regensburg. From left: Tim Bauer, Chief People Officer of the Aenova Group, Regensburg's Mayor Gertrud Maltz-Schwarzfischer, Oliver Schmied (Managing Director Aenova Regensburg), Dietmar Rohleder (Prange Group) (Photo: Aenova)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/news/_medium/Aenova_Regensburg_New-Building.jpg" data-image="557848" alt="New building Regensburg"><figcaption>The new building for highly effective pharmaceuticals at the Aenova site in Regensburg, Germany (Photo: Aenova) </figcaption></figure>

Aenova receives rating “Highest reputation: outstanding" in Focus Money Germany test

20/06/2023 - Aenova receives rating “Highest reputation: outstanding" in Focus Money Germany test

Starnberg, 20/06/2023

Aenova has been awarded the rating "Highest reputation: outstanding" by the german business magazine Focus Money. The award is based on a study by the Institute for Management and Economic Research (Institut für Management und Wirtschaftsforschung, IMWF), which analyzed the reputation of the 20,000 largest German companies in the areas of management, sustainability, product and service, performance. For this purpose, a total of 20 million reviews - customer ratings, testimonials, comments and more - from the Internet on the tested companies in the period from February 2022 to January 2023 were recorded and evaluated. Of the 20,000 companies, 1,000 received the "Highest Reputation" seal of approval and Aenova was able to position itself in the pharmaceutical sector alongside major international pharmaceutical companies with the award. "We are very pleased to receive this award," commented Jan Kengelbach, CEO of Aenova Group. "It reflects very well how the Aenova Group has developed over the last two years in the areas of performance, product, service, management and sustainability. This is a joint success to which every colleague has contributed!"
<figure><img src="https://www.aenova-group.com/content/news/_medium/Siegel_DT_Höchste-Reputation_2023_AENOVA-GROUP.jpg" data-image="557814" alt="Focus Money Auszeichnung für Aenova"><figcaption>Focus Money Award for Aenova</figcaption></figure>

Aenova with new organizational structure supporting future strategy

15/06/2023 - Aenova with new organizational structure supporting future strategy

Starnberg, 15/06/2023

Aenova has reorganized the company's organizational structure. The new management structure of the Executive Leadership Team is aligned with the company's growth strategy. Manufacturing operations, development and technology innovation are now positioned powerfully and equally alongside each other.
The Aenova Group, amongst the globally leading international contract manufacturers and developers for the pharmaceutical and healthcare industries, announces a new organizational structure for the Executive Leadership Team (ELT). The new management structure is aligned with the company's meticulous focus on operational excellence while supporting its growth strategy in development services. From now on, the new structure is giving equal clout to manufacturing operations as well as development services and technology innovation. “This reorganization will very well support Aenova's strategic positioning as an innovative CDMO champion”, explains Jan Kengelbach, CEO of the Aenova Group. “While the demand on our manufacturing services is higher than ever contributing to more than 20% organic growth year-to-date, so is the demand for our development services in particular in the high potent solids, solids with enhance bioavailability characteristics, and aseptic manufacturing. We are currently working on 60 development projects with our customers in clinical phase 1-3”, Jan Kengelbach continues. Specifically, this means that from now on all 14 manufacturing sites of Aenova Group will report directly to Roel de Nobel, the new Chief Operations Officer (COO). Florent Bordet, as new Chief Scientific Officer (CSO), will be the head of the newly created development services and technology innovation unit. This will cover product development, development services and manufacturing science and technology.
Chief Commercial Officer (CCO) Neil Jones will be responsible for the management of the existing business and drive the development and acquisition of new business opportunities. Tim Bauer as Chief People Officer (CPO) will continue to drive initiatives around employee engagement, employee motivation and talent acquisition. Dr Peter Waller was recently appointed as new Chief Financial Officer (CFO). The organizational changes are in line with Aenova's ambitious strategic direction as an innovative CDMO champion. This is focused on delivering ever higher output levels at highest quality and reliable delivery rates by expanding the manufacturing capacities across the network. And in addition, also it focusses on extending capabilities to offer more differentiated technologies and development capabilities for small molecules and large molecules fill and finish. With this, Aenova offers its customers solutions both for established molecules as well as the development of new chemical entities (NCE). "I look forward to shaping the future of Aenova together with this experienced, dedicated and visionary team. With Aenova's innovative solutions and outstanding capabilities, our customers have a reliable CDMO partner at their side for all their needs", comments Jan Kengelbach, CEO of the Aenova Group.<figure><img src="https://www.aenova-group.com/content/news/_medium/AE_ELT_qu.jpg" data-image="557771" alt="Aenova Executive Leadership Team 2023"><figcaption>Aenova Executive Leadership Team 2023</figcaption></figure>

Efficient handling of high-potent APIs, a CDMO perspective (lecture at 8th Annual High Potent Medicines Conference Milan 2023)

12/06/2023 - Efficient handling of high-potent APIs

Starnberg, 12/06/2023

In her lecture at the 8th Annual High Potent Medicines Conference on 24 / 25 May 2023 in Milan, Dr. Martina Breuer, Head of Operations, Aenova Group, addressed current challenges and strategies in handling of high-potent active pharmaceutical ingredients (HPAPIs). The agenda included an overview of the definition of high potent APIs /products, and their toxicology and safety implications in the processing, market insights and the smart and efficient production concept for handling HPAPIs with examples from Aenova's development and manufacturing sites. HPAPIs are significantly growing in today’s drug therapy and R&D pipelines. Today’s pharmaceutical development and manufacturing see a strong trend in outsourcing to service providers being experts in their fields. To master the challenges in flexibility and efficiency CDMOs must implement a holistic concept to HPAPI handling. Dr. Breuer focused on the aspect of shared facilities versus dedicated facilities and the regulatory requirements for high quality, safe and flexible manufacturing in shared facilities. For deeper insights see the Aenova <a href="https://www.aenova-group.com/content/resources/Aenova_Whitepaper_Safe-and-efficient-handling-of-high-potent-drug-products.pdf" target="_blank">whitepaper on “Safe and Efficient Handling of high-potent Drug Products”.</a><figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Closed_Containment_Graphic_mR.PNG" data-image="557732" alt="Closed Containment Graphic"><figcaption>Aenova Closed Containment Concept (Graphic: Aenova)</figcaption></figure>

Career orientation fair in Regensburg

07/06/2023 - Career orientation fair in Regensburg

Regensburg, 07/06/2023

At the beginning of May, the large career orientation fair of the Employment Agency and with partners from schools and business took place in the Danube Arena in Regensburg. Around 2,000 students learned about apprenticeships and career opportunities in a wide variety of fields: Craft, natural science, pedagogy, health, economy. Over 130 exhibitors presented their companies.
The Aenova site in Regensburg also participated in the fair. The demonstration of experiments at the Aenova booth and the many opportunities that the pharmaceutical industry offers for young people attracted lively interest. Aenova in Regensburg offers training in the following professions:<ul><li>Chemical laboratory assistants (m/f/d)</li><li>Pharmacist (m/f/d)</li><li>Mechatronics technician (m/f/d)</li></ul>
The locations of the Aenova Group have already been awarded several times by the IHK for excellent training.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_RGB-Messe_Gruppe.jpg" data-image="557701" alt="Berufsbildungsmesse Regensburg"><figcaption>The Aenova team Regensburg at the career orientation fair in May 2023</figcaption></figure>

Sisseln

Successful recertifications at Aenova site Sisseln

31/05/2023 - Successful recertifications at Aenova site Sisseln

Sisseln, 31/05/2023

Aenova, the world's leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, secures recertifications. In March 2023, Aenova's Sisseln site again successfully passed certification in ISO 9001 Quality Management System, ISO 14001 Environment, ISO 45001 Occupational Health and Safety, and FSSC 22000 Food Safety. The certifications must be repeated every three years. The Aenova Group's production site for complex conventional solids in Sisseln, Switzerland, has been certified in various ISO areas for more than ten years and relies on an effective management system for quality, environment, occupational health and safety, and food safety. Particularly because of its activities in the area of pharmaceutical products, effective management in these areas is important in order to demonstrate performance to employees and customers as well as to the community and the authorities. In terms of environmental performance, the Sisseln site has long demonstrated its responsibility: it operates free of fossil energy with 6 GwH of electricity from hydropower, uses also its own photovoltaic systems and is climate-neutral. "The Aenova site in Sisseln has special know-how and state-of-the-art infrastructure for the production and packaging of moisture-sensitive solid dosage forms and innovative technologies. We are highly aware of our own and our customers environmental responsibility. Obtaining several certificates at once makes us proud and confirms that we are setting the right priorities and are on a good path to a sustainable future," says Fridrik Thorsteinsson, Managing Director at the Aenova site in Sisseln..
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Sisseln_Frontview.jpg" data-image="557667" alt="Aenova Sisseln Haupteingang"><figcaption>Aenova site in Sisseln successfully recertified; on the right roof, solar panels as in operation on all roofs of the CO2-free site. (Photo: Aenova)</figcaption></figure>

Peter Waller appointed as new CFO of Aenova

17/05/2023 - Peter Waller appointed as new CFO of Aenova

Starnberg, 17/05/2023

Effective May 15, 2023, Dr. Peter Waller has been appointed as the new Chief Financial Officer of Aenova Group and Managing Director of Aenova Holding GmbH. "I am looking forward to contributing to Aenova's further success," commented Peter Waller on his start at Aenova. "The Aenova Group has a strong reputation as a development service provider and contract manufacturer for the pharmaceutical and healthcare industry and is well positioned for future profitable growth in coming years." Peter Waller succeeds CFO Ralf Schuler.
Peter Waller is an experienced CFO of international companies in various industries including Flender, Swissport International, CEVA Logistics and Eurofins. He has successfully led numerous transformations, IPOs, financings and M&A activities. Peter Waller holds Master´s degrees in Management from the University of Mannheim and the ESSEC Business School in Paris and a PhD in Economics from the University of Paderborn. Aenova's previous CFO, Ralf Schuler, will be available in the coming months to ensure a seamless transition. "We are delighted to welcome Peter Waller to our team. Peter has extensive experience to support the development of Aenova Group," explains CEO Jan Kengelbach. "With his drive and knowledge, Peter Waller will be a great asset to our team. At the same time, I would like to thank Ralf Schuler for his outstanding commitment over the past five years, during which he has played a key role in the successful repositioning of Aenova Group as our CFO." The Aenova Group is one of the leading international CDMOs (Contract Development and Manufacturing Organizations) for the pharmaceutical and healthcare industry. With around 4,100 employees at 15 locations worldwide, the company recorded sales revenues of around EUR 750 million in 2022.

Enabling innovation: challenges and strategies in solid dosage forms drug development services (lecture at World Pharma Summit 2023)

05/05/2023 - Enabling innovation: challenges and strategies in current drug development

Starnberg, 05/05/2023

In his lecture at the World Pharma Summit 2023 on April 26, 2023 in Frankfurt, Dr. Klaus Pollinger, Head of Manufacturing Science & Technology, BU Solids at Aenova, addressed challenges and strategies in current drug development. 
The agenda included an overview on current challenges and their backgrounds as well as the formulation of poorly soluble drugs and a case study. First, the speaker gave an overview of the current situation in research and development and, in particular, outlined the expectations that are placed on a development service provider today. Regarding the formulation of poorly soluble drugs, Klaus Pollinger explained trends and classifications and presented selected technologies. He concluded his presentation with case study on successful improvement of bioavailability in solid oral dosage forms. In summary, Klaus Pollinger emphasized how important development service providers can be in driving innovation in pharmaceutical development. By offering comprehensive know-how and an end-to-end service, customers ultimately benefit from cost and risk minimization as well as optimized timelines. Aenova supports drug projects with long and deep experience in development services through to commercial manufacturing, investments in expanded capabilities, new technologies and end-to-end services.<figure><img src="https://www.aenova-group.com/content/navigation/_medium/KP-auf-WPS-2023.JPG" data-image="557326" alt="Lecture Aenova WPS 2023"><figcaption>Aenova lecture on challenges in current drug development at the World Pharma Summit 2023</figcaption></figure>

CEO Jan Kengelbach about Trends in CDMO Market (Interview in GBR Life Sciences Report 2023)

27/04/2023 - CEO Jan Kengelbach about Trends in CDMO Market (Interview in GBR Life Sciences Report 2023)

Starnberg, 27/04/2023

In the latest edition of Global Business Reports' renowned US Life Sciences 2023 Report, Aenova outlines not only trends in the CDMO market but also highlights in capacities and capabilities at Aenova. In the interview, Aenova CEO Jan Kengelbach also explains latest achievements: "(...) About four years ago, we designed a new growth strategy. First, each site had to become a center of excellence for a certain technology, and second, in each site, we made the investment decisions to either expand existing capacities or extend the technology offering. In total, there are 15 new growth platforms at Aenova now, of which eight are commercially online yet. As an example of capacity expansion, we extended our high-volume Tittmoning site, Germany, to 10bn tablet capacity. We created a brand new sterile area fill and finish area (including biologics) for prefilled syringes and RTU vials at our Latina Site, Italy. The breadth of new technologies that we have put online is including the new high-potent API facility at our Regensburg site, Germany, the hot melt extrusion and templated inverted particles at our Sisseln site, Switzerland, or the new dry powder inhaler/microdosed capsule filling at our Münster site, Germany (...)." Read more in the <a href="https://projects.gbreports.com/united-states-life-sciences-2023/aenova-group-interview" target="_blank" style="margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; text-decoration: none; color: rgb(51, 151, 255); cursor: pointer; outline: 0px !important; box-sizing: inherit;">GBR US Life Sciences Report 2023</a>.

Aenova receives silver medal in EcoVadis sustainability rating

06/04/2023 - Aenova receives silver medal in EcoVadis sustainability rating

Starnberg, 06/04/2023

Aenova, one of world's leading contract development and manufacturing organisations for the pharmaceutical and healthcare industries, has achieved silver status in the latest EcoVadis sustainability rating. This documents the Aenova Group's continuous improvement of its sustainability in the categories "environment", "labor and human rights", "ethics" and "sustainable procurement".
Certified proof of sustainability in the areas of environment, labor, ethics and procurement is becoming increasingly important for companies and their suppliers. Around half of the world's leading pharmaceutical companies use the EcoVadis assessment for this purpose. The Aenova Group also undergoes an annual assessment by EcoVadis. In the areas of environment and labor and human rights, the best results were achieved with 70 out of 100 maximum possible points. With a percentile of 84, Aenova is among the top 25 percent of companies evaluated by EcoVadis. The production steps in the pharmaceutical industry are energy-intensive. A good Ecovadis result also distinguishes responsible action in the use of natural resources. According to Ecovadis, around 91% of companies now take sustainability criteria into account when making purchasing decisions. "Sustainability is not an empty phrase for us, but an important strategic goal," says Jan Kengelbach, CEO of Aenova Group. "Our sustainability strategy always includes further optimization in sustainability and environmental topics. For example, the Aenova site in Sisseln already operates completely CO2-free, many sites have photovoltaic systems as well as special wastewater treatment or their own combined heat and power plants, and we are continuously expanding the sites." The EcoVadis methodology covers a total of seven management indicators, comprising 21 sustainability criteria in four thematic areas: Environment, Labor and Human Rights, Ethics and Sustainable Procurement. It is based on leading standards such as GRI (Global Reporting Initiative), UNCC (UN Climate Change) and ISO 26000, and is overseen by an international scientific committee. It evaluates companies' performance by analyzing policies, measures and results.

Roel de Nobel new Head of Business Unit Solids at Aenova

23/03/2023 - Roel de Nobel new Head of Business Unit Solids at Aenova

Starnberg, 23/03/2023

As of February 01, 2023, Roel de Nobel is the new Senior Vice President of the Business Unit Solids at the pharmaceutical company Aenova. As a member of the Executive Leadership Team (ELT), he will play a key role in shaping the future and success of Aenova Group's seven solids sites, reporting directly to CEO Jan Kengelbach in his role.
Since February 01, 2023, Roel de Nobel has joined the Aenova Group as the new Senior Vice President of the Business Unit Solids and General Manager. As a member of the Executive Leadership Team (ELT), he will lead and significantly develop Aenova's total of seven solids sites. "I am delighted to be part of Aenova's success story now," comments de Nobel on joining Aenova. "Aenova’s expertise, capabilities and capacities in solid oral dosage forms is impressive. Together with my colleagues, we will do our best every day for our customers and thus for the supply of medicines to patients worldwide." De Nobel has extensive experience in the international consumer goods and pharmaceutical sectors and brings with him many years of expertise in the CDMO environment. He previously held various senior positions at Catalent, including Global Vice President Operations and Vice President & General Manager Asia Pacific. De Nobel studied Business Administration and Management.
The Business Unit Solids at Aenova provides not only high-volume production capacities for capsules, tablets and film-coated tablets, but also supports customers with innovative technologies focused on complex therapeutic systems or aimed, for example, at improving the bioavailability of the API. This means e.g. hot melt extrusion or co-precipitation, encapsulated mini tablet systems or multi-unit pellet systems (MUPS). These innovations also include projects in the field of highly potent drugs, particularly in oncology, in order to offer patients a simplified and less burdensome form of therapy.
With his extensive expertise, Roel de Nobel will place a special focus on the further development of Development Services and Clinical Trial Management (CTM). "In this way, we can offer our customers a particularly comprehensive service, as Aenova can provide almost freely scalable experience and competent support, from development, i.e. very small batches, up to high-volume commercial production, this all from a single source", explains de Nobel. "We are delighted to welcome Roel de Nobel to our team. Roel is a very experienced manager in the pharmaceutical industry and will expand the solid dosage form development within Aenova," comments CEO Jan Kengelbach. "Roel de Nobel will enrich our team with his drive, his ability to innovate and last but not least with his personality."

Aenova introduces new sterile strategy

10/03/2023 - Aenova introduces new sterile strategy

Starnberg, 10.03.2023

Aenova Group, a leading international contract developer and manufacturer for the pharmaceutical and healthcare industries, presents its new sterile strategy. In the future, the focus in sterile production will be on expanding the sterile site in Latina (Italy). There, portfolio and capacities are being expanded, especially in the area of prefilled syringes (PFS) as well as intramammary syringes.
Aenova Group, a leading international contract manufacturer and developer for the pharmaceutical and healthcare industries, has launched a restructuring program for its Sterile Manufacturing business within the semi-solida and liquida business unit. This is aimed at significantly expanding capacity at the large Aenova sterile site in Latina, Italy.Over the past 24 months, more than 20 million euros have been invested in the Latina plant to offer customers a high-performance site with state-of-the-art filling technology for sterile dosage forms, especially vials and PFS. This new manufacturing area has already been approved by the Italian authorities. Follow-on investments of approximately 15 million euros are currently underway to further expand the offering. This is mainly aimed at increasing capacity for prefilled syringes (PFS). This is Aenova's response to the market demand for PFS and the increased customer requirements for this fast-growing sterile dosage form. With further expansions, Aenova is also positioning itself as a service-oriented end-to-end provider in this area. In the course of this concentration, consequences will be drawn at Aenova's other sterile sites, as a comprehensive reorganization of the sites is not economically feasible, in particular due to the additional regulatory requirements for sterile production that are now coming into force. Therefore, the site in Wolfratshausen, Haupt Pharma Wolfratshausen GmbH, will be closed in 2023 and the sterile manufacturing sub-segment at the Gronau site, Haupt Pharma Wülfing GmbH, will be discontinued. Customer projects should be transferred or completed according to plan. At the Gronau site, the focus in the future will be on the successful solida business with capacity expansions already being implemented. "Our restructuring and focus on our Latina sterile site is targeting a growth market. This pays off for the entire Aenova strategy. It puts us in an excellent position for the future," explains Jan Kengelbach, CEO of the Aenova Group.

Marburg

New Managing Director at Aenova site in Marburg, Germany

01/03/2023 - New Managing Director at Aenova site in Marburg, Germany

Marburg, 01/03/2023

Effective March 01, 2023, Dr. Hanno Scheffczik has been appointed as the new Managing Director of Temmler Pharma GmbH, a member of the Aenova Group. The experienced general manager leads the site in Marburg with 150 employees and a focus on complex conventional solids and narcotics.
The Aenova Group is a leading international contract manufacturer and developer for the pharmaceutical and healthcare industry with 16 locations and around 4,200 employees worldwide. The Aenova site Marburg stands out within the group as a competence center for complex conventional solids and narcotics. With around 150 employees, the Aenova site in Marburg manufactures delayed-release tablets and capsules as well as moisture-sensitive dosage forms. Dr. Hanno Scheffczik has been appointed as the new Managing Director as of March 01, 2023. He replaces the long-standing managing director Dr. Alfred Veit, who is retiring.Dr. Hanno Scheffczik studied chemistry with a focus on biochemistry and earned his doctorate at the Institute of Virology at Philipps University in Marburg. After holding various development and management positions at well-known, international research-based pharmaceutical companies, he joined Aenova in 2021, initially as Head of Manufacturing Science & Technology. "I am looking forward to my tasks in Marburg and to working with a highly competent and committed team!", says Dr. Scheffczik. The Aenova site in Marburg has a history of over a century in pharmaceutical development and production and is one of the larger local employers. The company has particular expertise in the development and production of complex pellets with controlled release of active ingredients, such as encapsulated mini-tablets and multi-unit pellet systems (MUPS). This is aimed at improving the bioavailability of active pharmaceutical ingredients and is an example of the innovative strength of the Aenova site in Marburg. The site is GMP and FDA certified, among others. "With Dr. Scheffczik we have a long-standing experienced manager and expert who knows the industry and Aenova very well. We wish him every success in his new role," explains Jan Kengelbach, CEO of the Aenova Group.

Aenova employees donate to the Starnberger Tafel

07/02/2023 - Aenova employees donate to the Starnberger Tafel

Starnberg, 07/02/2023

Employees of the pharmaceutical contract manufacturer Aenova organized an internal donation for the Starnberger Tafel in December 2022. The official, symbolic handover of the check took place on February 2, 2023.
Starnberg, February 03, 2023 - The war in Ukraine, increased energy prices and inflation hit disadvantaged and socially weaker people particularly hard. Therefore, employees of Aenova, a global contract developer and manufacturer for the pharmaceutical and healthcare industry, organized a donation initiative before Christmas. At the Aenova headquarters in Starnberg, the employees collected a sum of money for the "Starnberger Tafel", a charitable organization that gives food that would be wasted to people in need. The joint donation amounts to 1,500 euros.
On February 02, 2023 the official, symbolic check handover took place. Two employees of Aenova visited the "Starnberger Tafel", informed themselves about the work of the Tafel and helped with the food distribution.
"Picking up and sorting the food is very time-consuming and the volunteers at the Starnberger Tafel work outdoors in all weathers", reflects Dr. Irayani Berger, Vice President Corporate Quality at Aenova. "A great commitment!", adds Dr. Susanne Knabe, Head of Corporate Communication at Aenova. "We are happy to be able to help people in the local area of Aenova's headquarters in Starnberg with the joint donation of our employees."
"We are very grateful for this unforeseen donation. Such donations support us in our work. There are many needy citizens who urgently need the food we collect", explains Erika Ardelt, first chairwoman of the board at Starnberger Tafel. 
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Spendenscheckübergabe_Starnberger_Tafel_02022023_kl.jpeg" data-image="556517" alt="Scheckübergabe Starnberg"><figcaption>Symbolic handover of the employee donation at the Starnberger Tafel: from left Doris Heger, treasurer of the Starnberger Tafel, Dr. Irayani Berger and Dr. Susanne Knabe, both Aenova, Christina Bolz, secretary at the Starnberger Tafel (Photo: Starnberger Tafel)</figcaption></figure>

Aenova successfully expands capsule filling capacity

11/01/2023 - Aenova successfully expands capsule filling capacity

Regensburg, 11/01/2023

Producing billions of capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing of hard capsule products.
At the Regensburg site, one of the leading HPAPI development, production and packaging facilities for high potent solids, production flexibility is a key issue. For this reason, the equipment at the site was expanded with a state-of-the-art IMA capsule filling machine: IMA Adapta 200. Oliver Schmied, Managing Director at the Regensburg site, explains the background in an interview with the machine manufacturer.
<h5>What were the drivers behind the project to expand your capsule filling capacity?</h5>
Having acquired new business involving large volumes of capsules to be produced at the Regensburg site, we were faced with the need to significantly increase our filling capacity as early as possible. Our focus was on obtaining highly efficient processes with a view to achieving maximum flexibility to best meet all customer requirements. It was evident from the start that we needed to implement the most recent, innovative technologies to reach our goals.
<h5>In terms of engineering capabilities and process optimisation, how would you describe the collaboration with IMA Active?</h5>
We had to address a number of issues, some of which were critical, so the most valued aspect of our relations with IMA can be summed up in a few words: transparent, open discussions and constructive input to find all the right answers. This is the basis of a true professional partnership and the benefits go in both directions, to the customer and the supplier. To mention one issue, considerable efforts were made by IMA’s engineering team to successfully install the new ADAPTA capsule filler into extremely limited floor space. Further to this, we were assured that the ADAPTA 200 could handle our products and during the preparatory stages of the FAT (Factory Acceptance Test; FAT is one of the qualification phases in the course of GMP qualification), together we were able to test the products of the machine and implement the ideal settings to guarantee optimum results.
<h5>Collaboration with IMA Active dates back to 1990, with acquisition of the first ZANASI capsule filler. Can you retrace the milestones of this partnership?</h5>
That’s right. 1990 marked the first purchase of a ZANASI capsule filler, the ZANASI 40 for commercial purposes. We then bought an additional ZANASI 5 and in 2021 acquired a ZANASI 12 which was devoted to batch development activities at our pilot plant, which was established as an in-house development facility between 2009 and 2010. Most of the products have been developed using the ZANASI equipment and subsequently tested and successfully manufactured on ADAPTA using the same filling principle. This eloquently reflects our many years of in-depth know-how in the field of development through to commercial production at the Regensburg site, especially for highly potent active ingredients such as those used against cancer.
<h5>Now that the new ADAPTA 200 is on site in Regensburg, tell us which of its features you appreciate most?</h5>
Firstly, let me say that in keeping with the Aenova Group’s policy to adopt cutting-edge technologies, the choice landed easily with ADAPTA 200. We immediately recognised the value of a high-speed solution enabling full scalability and large production capacity. The compact footprint has allowed us to free up enough space to include further potential filling requirements, which fits perfectly with our objective for increased capsule filling capacity.
More specifically, we are extremely satisfied with the real speeds reached. An output of 200,000 capsules/hour is exactly what we needed and ADAPTA 200 consistently achieves these figures. Let me say that many times the declared speed is not the real speed, but in this case there is no difference.
Another aspect which has impressed us is the 100% in-process weight checking capability. Real time monitoring and measuring of capsule weight is handled by the system directly connected to the machine, giving us the peace of mind that key parameters are respected. Last but not least, despite the space-efficient size of ADAPTA, and even with different dose combinations, the high production speeds are maintained. Finally, it is equally important for us to underline the broader benefits we enjoy from a product landscape that IMA has installed at our Regensburg site. The ZANASI machines – in particular the 12 E and the AZ 5 – are perfectly sized either for small batches or for product development activities. Together with the larger ZANASI capsule filler and the latest-generation ADAPTA 200, we are well-placed today to deliver the most flexible response to all our customers. And in today’s market, that is vital.
<figure><img src="https://www.aenova-group.com/content/_medium/IMA-RGB-2.png" data-image="555683" alt="Neue Kapselfüllmaschine am high-potent Standort Regensburg"><figcaption>New capsule filling machine at the Aenova high-potent Regensburg site (Photos: Aenova)</figcaption></figure>

Aenova Christmas campaign: employees donate to social organisations

16/12/2022 - Aenova Christmas campaign:  employees donate to social organizations

Starnberg, 16/12/2022

Aenova employees collected donations in kind and money for social institutions in Starnberg at the beginning of December 2022. These donations will be used to support two organizations that help disadvantaged people.
The year 2022 is and was a challenging year worldwide. The Corona pandemic was followed by the Ukraine war. Energy supply, price increases and inflation have since affected many people and organizations, including in Germany. Disadvantaged and socially weaker people are particularly affected.Therefore, Aenova, a leading global contract developer and manufacturer for the pharmaceutical and healthcare industries, organized two donation initiatives as a Christmas campaign. At Aenova's headquarters in Starnberg, employees collected donations in kind and a sum of money for two local social institutions: Winter clothing and shoes for children and adults, toys, tableware and household goods. Both institutions are very grateful for the spontaneous donations, especially now in the cold season and with partly declining donations in recent months. "We are pleased that we can support people in need and the socially disadvantaged with our joint contributions. A big thank you to our employees who made these joint campaigns possible," explains Dr. Susanne Knabe, Head of Corporate Communication at Aenova. "In the coming year, we plan to expand these initiatives." As part of its corporate social responsibility strategy, the company, with its 16 sites worldwide, is primarily involved in the local environment and supports charitable initiatives at the individual company locations. There are social institutions that prefer to work in silence and do not want to be named. A separate information will follow on the presentation of the check for the cash donation.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_STA_Weihnachtssachspende.jpg" data-image="555601" alt="Weihnachtsspende 2022"><figcaption>Aenova employees collected for charity at Christmas 2022. (Photo: Aenova)</figcaption></figure>

Münster

Training is important to us: Aenova Münster at CoeMBO 2022

06/12/2022 - Training is important to us: Aenova Münster at CoeMBO 2022

Münster, 06/12/2022

Training is of great importance at Aenova. With over 80 trainees within the Aenova Group, vocational training for the next generation is an integral part at all Aenova locations.At the career information fair CoeMBO on November 12, 2022 in the school center of the city of Coesfeld, Aenova Münster was on site with a team and informed many young interested students about all topics related to training at one of the world's leading contract manufacturers for the pharmaceutical and healthcare industry. Aenova's Münster site focuses on the development, production and packaging of high-potency and/or low-dose tablets and, in particular, hormones, hormone-like substances and narcotics. Another focus is on production technologies for micro-dosed capsules, e.g. with dry powder for inhalation. Around 250 employees contribute to the success of the site. The following training courses are offered: Apprenticeship as chemical laboratory assistant (m/f/d), pharmaceutical assistant (m/f/d), industrial clerk (m/f/d), IT specialist for system integration (m/f/d). Currently, 9 trainees are employed at Aenova in Münster. "We are pleased to be able to offer young people in the region interesting apprenticeships every year. The pharmaceutical industry is characterized by very good job and career prospects," explains Michael Obermeier, Head of Human Resources in Münster. "At the same time, we work here for the health of patients worldwide. That, of course, is another very special motivation," Obermeier continues. The CoeMBO is a trade fair for career guidance, where young people from Münsterland and the surrounding area get the opportunity to get an overview of the possibilities after graduating from school. After a two-year break from Corona, the fair was held again this year in presence. <figure><img src="https://www.aenova-group.com/content/_medium/Messe_Gruppenfoto-MST.jpg" data-image="555374"><figcaption>Team Aenova Münster at training event</figcaption></figure>

Innovations in oral solid dosage forms, Aenova expert article in EPM 11/12 2022

30/11/2022 - "Innovations in oral solid dosage forms", Aenova expert article in EPM 11/12 2022

Starnberg, 30/11/2022

Aenova has contributed an exclusive expert article to the current issue of the renowed magazine "European Pharmaceutical Manufacturer", 11/12 2022, with the title:
Innovations in oral solid dosage forms. Challenges for development and commercial manufacturing out of the perspective of a worldwide leading CDMO.
The focus is on key trends in the pharmaceutical market regarding oral solid dosage forms. The authors introduce differentiated technologies for complex therapeutic systems and enhanced bioavailability. Another aspect are the challenges in the development and production of high potent APIs. The summary concludes with tips for faster time to market for innovative OSDF.
Read more in the <a href="https://issuu.com/epmmagazineonline/docs/epm_nov_dec2022_22.6" target="_blank" style="font-family: SourceSansPro, Arial, Helvetica, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400;">current issue of European Pharmaceutical Manufacturer starting on page 18/19.</a>
<figure><img src="https://www.aenova-group.com/content/_medium/Snippet_Aenova_Article_EPM-for-teaser.JPG" data-image="555333"><figcaption>European Pharmaceutical Manufacturer 11/12 2022, p. 18-19</figcaption></figure>

Interesting insights for school students into the pharmaceutical professional world

18/11/2022 - National Future Day at Aenova in Switzerland a complete success

Kirchberg / Sisseln, 18.11.2022

It's been a long time since there was so much going on at our manufacturing sites in Kirchberg and Sisseln, Switzerland: both sites were buzzing like a beehive, so many interested young students had registered for the National Future Day in Switzerland on November 10.And there was a lot on offer: there were experiments, welding, milling, guided tours of the laboratories, production and the high-bay warehouse. Many questions were asked and these were answered in detail and vividly, e.g. on the topics of hygiene and cleanliness in pharmaceutical production, on apprenticeships in the pharmaceutical and healthcare industry, and much more. The young people and their curiosity about what we do at Aenova, what perspectives there are in professional life and above all: how to give a change of perspective on the classic girl and boy roles in career choice were the focus of the day. At the end of the day, the unanimous feedback was: this open day was a great opportunity to look behind the scenes of one of the world's leading pharmaceutical contract manufacturers. A big thank you to all the young visitors for coming - a big thank you to all our employees who made the day an experience for young and old alike! We look forward to the next Future Day next year! 
<figure><img src="https://www.aenova-group.com/content/_medium/ZUkunftstag-CH-2022-EN.jpg" data-image="555288" alt="Nationaler Zukunftstag"><figcaption>Experiments, guided tours and lots of fun: National Future Day at the Aenova sites in Kirchberg and Sisseln</figcaption></figure>

Gronau

Best pharmacist trainee in Lower Saxony completed her training at Aenova site in Gronau

14/11/2022 - Best pharmacist trainee has completed training at Aenova

Gronau, 14/11/2022

The best trainees in Lower Saxony were honored last week at the GOP Varieté Theater in Hanover: 110 young professionals completed their vocational training at IHK member companies this year with the grade "very good" and were recognized as the best in their training profession.
This includes a young trainee who completed her training at the Aenova site in Gronau. She was honored as the best pharmacist of the year.
Our young colleague not only performed excellently, but also completed her training in 2.5 years instead of the usual 3.5 years. She will be working in the laboratory at the site in the future. Congratulations on this first-class result!
At Aenova we attach great importance to the training of the younger generation and this task is very important to us. We train in the following professions at our sites:<ul><li>Pharmacist</li><li>Chemical laboratory technician</li><li>Industrial mechanic</li><li>Warehouse logistics specialist</li><li>Industrial clerk</li><li>Machine and plant operator</li><li>IT specialist for system integration</li></ul>
We take our responsibility for providing qualified vocational training for our junior staff very seriously. This top performance is also the result of the great commitment of the training company and the vocational school and illustrates the high quality of dual training.<figure><img src="https://www.aenova-group.com/content/_medium/B2022_BOM_TAB_Auszeichnung.jpg" data-image="555247" alt="Aenova Gronau IHK Ceremony"><figcaption>Best pharmacist trainee in Lower Saxony together with the training officer at the Aenova site in Gronau</figcaption></figure>

Micro-dosed capsule filling and dry powder inhalation are key innovation topics at Aenova

26/10/2022 - Micro-dosed capsule filling and dry powder inhalation at Aenova

Münster, 26/10/2022

Dry powder inhalation using a DPI device (dry powder inhaler) is becoming more and more important for patient care in view of the worldwide increase in lung and respiratory diseases. The need for therapeutics for bronchial asthma and COPD (chronic obstructive pulmonary disease), for example, is also rising worldwide. Many of the therapies need to be used by patients for life, which underscores the need to make DPI cost-effectively available and easy for patients to use.The galenic formulation of the active ingredients is particularly challenging, as the inhalable aerosol particles must have an aerodynamic diameter of 1 to 5 µm over the entire shelf life of the product in order to ensure adequate pulmonary mobility. For this purpose, Aenova has a state-of-the-art DPI capsule production and proven expertise from development to commercial production. With state-of-the-art micro-dosing technology, Aenova ensures full scalability for DPI capsule products (flexible batch sizes from 0.5 kg to commercial sizes). In addition, there are product-specific analysis options according to EP / USP as well as specific blistering and combination packaging solutions. Together with the customer, Aenova creates a purposeful concept phase and a product design precisely tailored to the requirements - including analytical method development, ICH stability testing, development and validation of the manufacturing process to obtain a safe and stable effect of the drug product. The modern high-speed capsule filling machine at the Aenova site in Münster is suitable for product dosing in the range of 5 mg to 50 mg per capsule and is equipped with 100% control, which enables in-process control of each individual capsule and ensures the highest quality of the final low-dose product. If required, additional modular dosing units can be integrated to combine also different dosage forms, e.g. pellets and powder, tablets and pellets and other variants. "We are very proud to be able to offer such a comprehensive service from development to commercial production in the field of dry powder inhalation and micro-dosed capsule filling of highly potent active ingredients," says Dr. Gereon Rau, Team Lead - Capsule Technologies at Aenova. "Our innovative solutions and reliable production and delivery capabilities are of benefit to our customers in the pharmaceutical industry and, last but not least, to patients with respiratory diseases worldwide." 
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Capsule-filling-machine.jpg" data-image="555136" alt="Mikrodosierte Kapselabfüllung"><figcaption>State-of-the-art capsule filling machine for low-dose capsule filling at the Aenova site in Münster (Photo: Aenova)</figcaption></figure>

Aenova Weniger Medikamente zu hoeheren Preisen CHE Manager 10 2022

Fewer drugs at higher prices? Statement Aenova CEO Jan Kengelbach on the current macroeconomic situation

24/10/2022 - Fewer drugs at higher prices? Aenova CEO Jan Kengelbach on the current macroeconomic situation

Starnberg, 24/10/2022

Aenova CEO Jan Kengelbach gives a statement on the current macroeconomic situation in the current issue of CHEManager (10/2022).
With the title "Fewer drugs at higher prices? The supply of pharmaceutical products in Europe is under pressure", Jan Kengelbach analyzes the consequences of the Ukraine war, the global disruptions to supply chains and energy supply, the enormous price increases accompanied by a highly volatile price situation, and the resulting challenges for CDMOs, customers and the supply of medicines to patients worldwide. Read more in the current issue of <a href="https://www.chemanager-online.com/news/weniger-medikamente-zu-hoeheren-preisen" target="_blank">CHEManager 10/2022</a> (article in German language). 

<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Qualitaetskontrolle_SGC_Kirchberg.JPG" data-image="555102" alt="Quality control Softgels Kirchberg"><figcaption>Quality control Softgels (Photo: Aenova)</figcaption></figure>

Commercial production for high-precision microencapsulation systems: Aenova and Microcaps launch strategic partnership

20/10/2022 - Commercial production for high-precision microencapsulation systems: strategic partnership of Aenova and Microcaps

Starnberg, 20/10/2022

The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industry. As a one-stop-shop, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes from pharmaceuticals to dietary supplements for human and animal health. Microcaps is an innovative, multi-award winning Swiss start-up company that has developed a novel, high-precision microencapsulation technology with scalable production capacity. Now Aenova and Microcaps are entering into a strategic partnership that will start on October 31, 2022. The aim of the partnership is to accelerate and improve the development and production of pharmaceuticals, food supplements and numerous other products. Microcaps will contribute its expertise in innovative, high-precision microencapsulation. The process uses a patented technology platform that enables customized formulations, e.g. in release, protective coating and texture. Together with Microcaps' technology, Aenova can offer an even broader range of new product development and life cycle management solutions for micro- and convention capsule formulations, such as enhanced taste masking, controlled release, targeted release, increased bioavailability and improved Active Pharmaceutical Ingredient (API) stability. Aenova as a CDMO (Contract Development and Manufacturing Organization) with a broad portfolio, brings to the partnership long-standing expertise, extensive GMP knowledge, international resources, rapid scalability and effective market access for the technology. With the EOS 1000 series, Microcaps recently launched the first solution that enables continuous encapsulation of active pharmaceutical ingredients on an industrial scale. At its core, the technology consists of several identical microchannels that can introduce well over 100,000 microcapsules of the same shape, size and properties, thus ensuring the highest quality standards. As a strategic industrial CDMO partner of Microcaps, Aenova will offer this patented technology for customer projects at its sites, for example in Kirchberg, Switzerland, or Cornu, Romania. Kirchberg is specialized as a Competence Center for the development and production of pharmaceutical soft capsules within the Aenova Group. Highly potent active pharmaceutical ingredients up to OEB 5 can also be processed there in softgel capsules, for which the innovative technology of microcaps offers new possibilities for specific customer requirements. The Cornu site is a competence center for the production of softgel capsules and Aenova VegaGels®. Here, Microcaps' novel microencapsulation technology can be used to improve the bioavailability of active food ingredients, e.g. vitamins, vegetable and essential oils, cannabidiol and others. The two managing directors of the new partners, Jan Kengelbach, CEO of Aenova Group, which is the industry partner of the cooperation, and Michael Hagander, co-founder and co-CEO of the startup company Microcaps, agree: "In our now launched partnership, the whole is clearly more than the sum of its parts, because the portfolio and the experience and knowledge of the individual companies complement each other perfectly in order to be able to offer even better added value for our customers in the pharmaceutical as well as the food industry even faster." At this year's CPhI, you can find out more about the new partnership from November 1 to 3, 2022 in Frankfurt/Main at the Aenova in Hall 9, booth no. 90J60.
<figure><img src="https://www.aenova-group.com/content/_medium/Microcaps-Mikroverkapselung.jpg" data-image="554970" alt="Mikroverkapselung"><figcaption>Customized formulations with high-precision equipment (photos: Microcaps)</figcaption></figure>

Tittmoning

Aenova at the 14th Training Day in Traunstein

13/10/2022 - Aenova at the 14th Training Day in Traunstein

Tittmoning, 13/10/2022

The 14th Training Day in Traunstein gives students a comprehensive overview of the professions and training courses or secondary schools in the Chiemgau / Southeast Bavaria region. In addition, numerous exhibitors, as well as a team from the Aenova site in Tittmoning, are on site for information and conversation.
Training and the promotion of the young generation is of great importance at Aenova. Aenova is not only a training company that has received several awards from the IHK (Chamber of Industry and Commerce), but also offers trainees excellent prospects in a future-proof and innovative industry. Aenova currently trains more than 80 apprentices at its 15 production sites in the following fields of training:<ul><li>Pharmacist</li><li>chemical laboratory technician</li><li>Industrial mechanic</li><li>Warehouse logistics specialist</li><li>Industrial clerk</li><li>Machine and plant operator</li><li>IT specialist for system integration</li></ul>
The 14th Training Day will take place on Oct. 21, 2022, from 2 to 5 p.m. at the Traunstein School Center. Participation is free of charge. Further information is available on the <a href="https://www.wirtschaftsverband-traunstein.de/tagderausbildung/" target="_blank">event website</a>.<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Ausbildungsmesse-FotoIMG_4577-Originalgrösse.jpeg" data-image="547074" alt="Ausbildung Tittmoning Messestand"><figcaption>Training trade fair, Aenova-Team Tittmoning (Photo: Aenova)</figcaption></figure>

Aenova Regensburg at "Nacht schafft Wissen"

11/10/2022 - Aenova Regensburg at "Nacht schafft Wissen"

Regensburg, 11/10/2022

"Nacht schafft Wissen" (Night Creates Knowledge) is a format that is now well established in Regensburg to bring "Innovations made in Regensburg" closer to the people. The event focuses on research, science and development and offers an evening-long look behind the scenes of Regensburg companies and universities. The numerous organizers have put together an exciting, educational and entertaining program.
The Aenova site in Regensburg is already one of the long-standing supporters of this event. At Aenova's Regensburg site, approximately 420 employees work in the laboratory, in analytics, production or packaging. The strategic focus is on the production of tablets or capsules used in cancer therapy.
<h5>Program points of the evening at Aenova in Regensburg:</h5>
<ul><li>Guided tour: production of highly potent drugs in the clean room.</li><li>Analytical laboratory - In search of the active ingredient in the tablet</li><li>Haupt Pharma Amareg, Member of the Aenova Group, as employer and training company</li><li>Exhibition: Pharmaceutical production in Regensburg</li></ul>
Regensburg: 21 October 2022, 17:00 to 23:00
For further information please visit the <a href="https://www.nacht-schafft-wissen.de/" target="_blank">website "Nacht schafft Wissen"</a>. We look forward to seeing you there!

<figure><img src="https://www.aenova-group.com/content/_portrait/554917/Aenova_RGB_NachtschafftWissen_Posting-3.jpg" data-image="554917" alt="Regensburg Nacht schafft Wissen"><figcaption>Test demonstration at the Aenova site at "Nacht schafft Wissen" (Night creates knowledge)</figcaption></figure>
Header graphic: @Stadtmarketing Regensburg

Aenova publishes white paper on the "Safe and efficient handling of high potent drug products"

07/10/2022 - New white paper on the "Safe and efficient handling of high potent drug products"

Starnberg, 07.10.2022

The market for HPAPI (High Potent Active Pharmaceutical Ingredients) will continue to grow in the coming years and decades. HPAPIs are used, among other indications, for the treatment of oncological diseases, immunosuppression and hormone therapy or endocrine therapy. Highly potent pharmacological agents are frequently used to treat diseases for which patients have a particularly high medical need. Therefore, the development and production of these mostly life-sustaining or life-saving HPAPI products already play a particularly important role for Aenova as one of the world's leading CDMOs (Contract Development and Manufacturing Organization). Since many molecules in the aforementioned indication areas are in the preclinical or clinical trial phase, safety in production is a particular challenge for commercial production due to potential toxicity. The development and manufacturing of drugs with highly potent active ingredients is very complex and often has to be done under great time pressure, as many of these new molecular entities (NMEs) are approved as "breakthrough therapy" in a fast-track process to quickly address a high unmet medical need. For such scenarios, pharmaceutical companies need reliable and experienced CDMOs as partners at their side. At Aenova, experts in the field of HPAPI production have therefore developed and implemented a holistic concept for the safe and efficient handling of HPAPI. This concept - from the basics to practical implementation - has now been published in the white paper "Safe and Efficient Handling of High Potent Drug Products".
The handling of highly potent active pharmaceutical ingredients is internationally regulated in OEB or OEL classes (Occupational Exposure Banding or Occupational Exposure Limits) in order to ensure both the quality of the product and the health of the processing personnel. In the risk assessment developed by Aenova, the potency of the active ingredient, the physio-chemical properties, the quantity and the duration are set in relation to each other in order to achieve the best possible risk minimization in development and production. For the safe and efficient development and production of highly potent active ingredients, the structural measures, the production facilities themselves, the processes, and the training and "mindset" of the employees follow a sophisticated, holistic production concept.<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Holistic-Concept-HPAPI-Production_1.png" data-image="554890"><figcaption>An intelligent and efficient production concept ensures Excellence in HPAPI handling (Graphic:	Aenova Group)</figcaption></figure>

Advantages and deeper insights are provided in the new whitepaper from Aenova, which can be requested free of charge by sending an <a href="mailto:contact-sales@aenova-group.com?subject=Request for Aenova Whitepaper " safe="" and="" efficient="" handling="" of="" high="" potent="" drug="" products""="">e-mail</a>.

New Aenova white paper in cooperation with c&en on "Innovations in drug formulations"

28/09/2022 - New Aenova white paper on "Innovations in drug formulations" in cooperation with c&en

Starnberg, 28.09.2022

For an API (active pharmaceutical ingredient), i.e. the active pharmaceutical ingredient of a drug, to have an optimal effect on the patient, the formulation is an essential component. It therefore matters how the active ingredient is "wrapped" - e.g. as a tablet, capsule or powder. The drug production methods used in this process are constantly evolving, and Aenova, as one of the world's leading CDMOs (Contract Development and Manufacturing Organization), offers its customers in the pharmaceutical industry innovative formulation solutions - with the aim of further optimizing the efficacy and tolerability of drugs.
In collaboration with the renowned expert portal c&en, journal of the American Chemical Society, Aenova has now created a white paper specifically on the topic of how innovations in solid dosage formulation can be particularly promoted through partnerships. Title of the whitepaper "Formulation Innovation: Partnerships Usher in Next Wave of Solid Dosage Forms".
Some advanced active ingredients are not compatible with standard formulations due to problems with stability, solubility or other physicochemical properties. This white paper discusses innovative approaches to the formulation of solid dosage forms as well as in terms of novel therapy-enhancing delivery systems, e.g. dry powder inhalers with special capsules for asthma patients.
Numerous innovative manufacturing techniques can be used to improve the bioavailability and thus the efficacy of drugs. For example, the white paper describes "hot melt extrusion" for active ingredients with low bioavailability, polymer encapsulation with minispheres for sustained release, as well as coprecipitation and other technologies.
Aenova offers its customers a full service portfolio for innovative oral solid dosage form technologies from development to commercial production.
The white paper "Formulation Innovation: Partnerships Usher in Next Wave of Solid Dosage Forms" can be downloaded free of charge <a href="https://connect.acspubs.org/Aenova_CDMOPartnerships?partnerref=CENAenova" target="_blank">under this link</a>.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Hot-melt-extrusion.jpg" data-image="554735" alt="Aenova Hot melt extrusion"><figcaption>Hot melt extrusion technique for the production of solids with optimized solubility (Figure: Aenova)</figcaption></figure>

Aenova expands portfolio with innovative technologies

31/08/2022 - Aenova expands portfolio with innovative technologies

Starnberg, 31/08/2022

The development of new drug products for a wide range of therapeutic areas is a rapidly growing market. Therefore, a smart innovation strategy is essential for contract developers and manufacturers. Aenova is expanding its development and production portfolio, particularly in the area of bioavailability of active pharmaceutical ingredients.
The development of new drug products and forms of therapy is progressing rapidly. For contract developers and manufacturers, this means staying on the cutting edge of production technologies and actively supporting customers with innovative approaches as early as the development service stage. At Aenova, one of the world's leading CDMOs, there are currently various initiatives for differentiated technologies within the innovation strategy, which are primarily targeted at patient-friendly forms of therapy based on complex therapeutic systems and the improved bioavailability of active ingredients.
<h5>Differentiated technologies for complex therapeutic systems</h5>
In the field of complex solid dosage forms, intelligently encapsulated mini tablet systems or multi-unit pellet systems (MUPS) can control the release of the active ingredient(s). On the one hand, this can increase the bioavailability of the active ingredient, but it also enables the combination of different active ingredients to improve the therapeutic effect of different molecules.
As well, Aenova is working with a dry powder inhaler (DPI) platform for micro-dosed capsule filling, which contain tiny amounts of the active ingredient down to the microgram. This enables, for example, improved therapy of bronchial asthma and chronic obstructive pulmonary disease (COPD).
<h5>Differentiated technologies for better bioavailability</h5>
Innovative active ingredients show a strong trend towards poor water solubility and low bioavailability. Aenova offers technologies to overcome these obstacles.
One example is the so-called Hot Melt Extrusion (HME), with which improved bioavailability can be efficiently achieved, since active ingredients are present as an amorphous solid dispersion. Hot melt extrusion offers a wide variety of options for further processing of the extrudate for solid dosage forms.
In addition, Aenova offers co-precipitation, particle sizing and lipid-based soft capsule formulations as successful technological strategies to increase bioavailability.
These innovations also include projects in the field of highly potent drugs, particularly in oncology, in order to offer patients a simplified and less burdensome form of therapy. With the Aenova Closed Containment System, the company has developed a holistic production concept for the safe and efficient manufacturing of highly potent active ingredients up to OEB 5 - active ingredients that are also increasingly being used in innovative medicines.
<h5>High level of innovation</h5>
Not every CDMO can offer innovative technologies, but it is crucial for contract manufacturers and developers to signal to their pharma customers that new products are also feasible with a strong and innovative CDMO partner. "If you want to be part of the strategic and advanced manufacturing of pharmaceuticals, a CDMO needs not only modern production facilities with suitable capacities, but above all strong development and technology transfer services," explains Jan Kengelbach, CEO of Aenova Group. "If a customer has a more complicated request, we have built up the appropriate level of scientific expertise and state-of-the-art process technology so that the customer knows immediately that they have found a reliable partner," Kengelbach further explains.
<h5>From the development of new drug products to commercial production</h5>
Larger pharmaceutical companies have their own development teams, but may still need a manufacturing and development partner to bring their product to market. Young companies or start-ups often pursue an "asset-light" model without in-house manufacturing capabilities and rely on a fully integrated development service from their CDMO partner. Here Aenova can provide support from development through clinical phases to commercial manufacturing.
<h5>Smart partnering models for fast time-to-market of new drug products</h5>
With its innovation strategy, the Aenova Group also addresses at smart partnership models with customers, because the technologies and the innovation-oriented mindset make it possible to invest in new projects together with customers and to bring innovative products to market. 
With a highly flexible range of GMP services (batch size, technologies and broad know-how along the product life cycle), Aenova positions itself as the ideal partner to bring innovative products from research into clinical trials ('first-in-man' to Phase III) and to manage all phases up to the worldwide product launch as CDMO. This partnership approach then quickly leads to the establishment of new platforms and means faster time-to-market for innovative medicines with the experienced CDMO partner at their side. 

<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Pellet_Loading-and-Coating.jpg" data-image="554426" alt="Aenova Pellets Marburg"><figcaption>Loading of the pellet coater (left) and pellet coating in the bottom spray process (right) for innovative multi-pellet tablets (Photos: Aenova)</figcaption></figure>

Neil Jones is appointed as the new Chief Commercial Officer of Aenova Group

01/08/2022 - Neil Jones is appointed as the new Chief Commercial Officer of Aenova Group

Starnberg, 01/08/2022

Neil Jones has been the new Chief Commercial Officer (CCO) of Aenova Group since July 18, 2022. As a member of the Executive Leadership Team (ELT), he will play a key role in shaping the future and commercial success of Aenova Group and will report directly to CEO Jan Kengelbach in his role. As of July 18, 2022, Neil Jones has joined Aenova as the new Chief Commercial Officer (CCO) of the Aenova Group. As a member of the Executive Leadership Team (ELT), he manages Aenova's commercial operations and will play a key role in shaping and expanding them. "I am very happy to now become part of Aenova's success story," commented Jones on his start at Aenova. "Together with my new colleagues, we will ensure and further expand the international success of the Aenova Group and best position the organization for future challenges in the competitive CDMO market environment." Neil has extensive experience in the pharmaceutical and biotechnology industries in both product and service areas. Prior to joining Aenova, he was Vice President at Catalent Pharma Solutions and CEO and CBO at VMIC (Vaccine Manufacturing and Innovation Centre). Prior to that, he served as Director Business Development Europe at Catalent Pharma Solutions from 2016 to 2021 and previously held various positions at Patheon. Neil holds a Bachelor of Science in Chemistry from the University of Bristol and a Post Graduate Certificate in Management from the University of the West of England. "We are very pleased to welcome Neil to the team. Neil is a manager who is highly experienced in the pharmaceutical-biotechnology industry and is perfectly placed for the central position of CCO at Aenova," commented CEO Jan Kengelbach on the appointment. "Neil will greatly enrich our team with his drive, his innovative ability and last but not least with his personal and human values."

The Aenova Group publishes Annual Report 2021

29/07/2022 - The Aenova Group publishes Annual Report 2021

Starnberg, 29/07/2022

The Aenova Group publishes its 2021 Annual Report today. 
The key figures 2021 of Aenova at a glance:<ul><li>€107 million adjusted EBITDA*</li><li>€125 million in additional new projects</li><li>89 % on-time deliveries (annual average on-time delivery, OTD)</li></ul>
"2021 was a challenging year for many industries, including the pharmaceutical industry," said Jan Kengelbach, CEO of Aenova Group. "Not unlike many of our customers, suppliers and market peers, we had to deal with several waves of pandemic-related restrictions, which definitely impacted our operational business. However, looking back, we can positively summarize that the entire Aenova Group has shown a very high resilience and that we have stayed on track with our transformation program, even though our financial performance was slightly below the previous year," Kengelbach added. Expressed in figures, this means a year-on-year decline in sales of 5.8% (2021: €697 million; 2020: €740 million). However, the Aenova Group was able to further increase the EBITDA margin from 15.1 % in the previous year to 15.3 %, thus achieving the best EBITDA margin in the entire history of the company in 2021. Thus, in 2021, Aenova's already robust financial base could be further built up. Learn more about Aenova's 2021 achievements and milestones, as well as key events in each business unit.
Read <a href="https://www.aenova-group.com/content/Aenova_Annual_Report_2021.pdf" target="_blank">more</a>.
* pro forma, excl. Berlin

Aenova wins ifm/GIB Supply Chain Management Award

15/07/2022 - Aenova wins Supply Chain Management Award

Starnberg, 15/07/2022

As a global leader in contract development and manufacturing, Aenova focuses on innovation, including digital transformation of supply chain management. As a successor system to SAP APO, the planning and operations module from the GIB Suite was implemented at three sites. The new solution significantly optimizes planning and scheduling efforts end to end. For this, Aenova received one of the three prestigious SCM Awards from ifm (formerly GIB).
As one of the leading contract developers and manufacturers for the pharmaceutical and healthcare industry, the Aenova Group is constantly working on innovations and optimizations. This also applies to the systems around supply chain management. As a successor system to SAP APO, the SAP-integrated Planning module from the GIB Suite has been implemented at the Münster and Wolfratshausen sites and in Latina (Italy) since fall 2020. In a second step, the Operations module was gradually rolled out at all three sites to optimize the processes in purchasing and scheduling. As a result, all former APO processes have been effectively replaced. The largest German Aenova site in Tittmoning has also been working with the Operations module since July 2022 to handle its complex purchasing processes. In addition to the operative day-to-day business, all locations now have the option of displaying requirements, consumption, backlogs or inventories graphically and in tabular form. All locations have heterogeneous IT structures that have grown over many years and a far-reaching consolidation of settings, customizing and interfaces was necessary. In order to reduce the effort in planning and scheduling and at the same time optimize the SCM processes, the Aenova Group decided with the software manufacturer ifm (formerly GIB) to choose the GIB Suite Tools for scheduling and planning as a replacement for the existing SAP APO. The entire conversion - from conception to test phases to implementation - took only 24 months, including the development and implementation of special functions, e.g. for the optimized planning of setup and cleaning times. The new solution has significantly reduced planning and scheduling costs. Processes have been smoothed and additional work has been significantly reduced, which has also led to a sustainable increase in staff satisfaction. Overall, Aenova has succeeded in optimizing SAP-controlled supply chain processes end-to-end thanks to the ifm solutions. Since the two tools were introduced in record time, Excel planning has become a thing of the past. The success achieved with the software has just been recognized with an SCM award from GIB. "The Aenova teams at the individual sites as well as the great support from the experts at GIB have brought us resounding success," says a delighted Frank Augustin, project manager and long-time SAP expert at the Aenova Group. "Optimized logistics and smooth supply chain management are crucial competitive advantages, especially for us as a contract manufacturer, and a weighty part of our Digital Transformation journey," adds Damir Juricic, Vice President Corporate IT at Aenova Group. "Congratulations to the whole team!" From 2023, the controlling module from the GIB Suite will also enter the test phase for a few months. This module can be used to classify and analyze inventories according to A B C, slow and fast movers, core stocks, store stocks, and so on. Here, the Aenova project team expects another major benefit.
On the cover picture: Frank Augustin, Aenova Group, is pleased to receive the award from Bilgin Kilic (left) and Björn Dunkel (right, both ifm Business Solutions) (Photo: IFM Business Solutions / G. Bender)
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_SCM-Award_2022.jpg" data-image="553653" alt="Aenova SCM Award 2022"><figcaption>Aenova has received a 2022 GIB Supply Chain Management Award for outstanding optimization in planning and scheduling. (Photo: Aenova)</figcaption></figure>

Holistic sustainability strategy at Aenova: the CO2-free Sisseln site

29/06/2022 - Holistic sustainability strategy at Aenova: the CO2-free Sisseln site

Sisseln, 29/06/2022

The Aenova site in Sisseln, Switzerland, stands for many years of tradition and special know-how, including in the production and packaging of moisture-sensitive solid dosage forms. A comprehensive sustainability strategy is pursued and this makes the site "CO2-free". The environmental program is subject to an annual implementation check and thus continuously anchors sustainability in everyday work.
In Sisseln, Switzerland, high-quality tablets, granules, effervescent tablets and hard capsules are produced by Aenova on a footprint of more than 6,000 m2 and a production area of more than 1,900 m2 by 160 employees - and with a completely CO2-free energy supply by using electricity generated from hydropower. That´s 6 GWh per year of certified electricity from Swiss hydropower; this is supplemented by a photovoltaic system that covers around 8 to 10% of the site's energy requirements. In addition, heat is generated using a particularly smart approach: Process and comfort heat is obtained via heat exchangers as a by-product of the air compressors. As a result, the energy supply of the Aenova site in Sisseln is not only climate-neutral but completely CO2-free. This protects the environment in the best possible way and reduces the consumption of natural resources. For more than ten years, the site has been ISO certified according to ISO 9001, ISO 14001, FSSC 22000 and OHSAS 18001/ISO 45001. In addition, all major projects are approved and supported by the Swiss Federal Office for the Environment.<h5>Good for nature, good for employees</h5>
At the Sisseln site, a total of seven charging facilities for electric cars are available for use by employees at cost price. This service supports the switch to environmentally friendly mobility. And not just for Aenova employees - the plant's neighbors are also offered the use of the charging facilities at the same conditions. Another measure to reduce CO2 emissions is the use of regional food in the site's canteen since the beginning of 2022, offering around 50% vegetarian dishes to also reduce the CO2 footprint of food production and transport.<h5>Measurable effects</h5>
The comprehensive sustainability concept at the Aenova site in Sisseln and its impact on the environment can be measured and demonstrably expressed in figures:<ul><li>0 liters oil consumption</li><li>0 m3 Gas consumption</li><li>0.45 MWh electricity from solar energy</li><li>6 GWh of certified electricity from Swiss hydropower</li><li>4,744 km ridden by 16 employees as part of the "Bike to Work" campaign</li><li>90% LED illuminant</li><li>54 t per year Recycling (paper, plastic, metal, wood)</li></ul>"Our holistic sustainability strategy and comprehensive sustainability management already make us proud," says Fridrik Thorsteinsson, Managing Director at the Sisseln site. "We are convinced that we can thus contribute to environmental protection in production as well as in everyday life. This is particularly sustainable because our colleagues are involved in the individual projects and can thus help shape and experience sustainability. This benefits the environment, nature as well as society in the region." Jan Kengelbach, CEO of Aenova, adds: "We are investing around CHF 2 million in environmental protection measures here between 2020 and 2022. Such a commitment is important to us at the Aenova Group: because this is how we, as a company, make a local contribution to sustainability, and that is an essential investment in the future. In the overall sustainability strategy of Aenova, our site in Sisseln is exemplary. We also support comprehensive sustainability initiatives at the other Aenova sites on our way to CO2 neutrality."
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Photovoltaik_Sisseln.JPG" data-image="553087" alt="Photovoltaik Sisseln"><figcaption>Large-scale photovoltaic systems are in operation on all roofs at the Sisseln site (Photo: Aenova)</figcaption></figure>

Aenova signs "Diversity Charter"

03/06/2022 - Aenova signs "Diversity Charter"

Starnberg, 03/06/2022

Aenova, global leading contract development and manufacturing organisation for the pharmaceutical and healthcare industries, signed the "Diversity Charter", a voluntary commitment to diversity, at the end of 2021. Through this commitment, the Aenova Group underscores its recognition of an appreciative work environment for all employees - regardless of, for example, their age, ethnic origin, nationality, gender identity or religion.
The diversity of society is increasingly shaping the world of work, not only in Germany but also worldwide. Companies can only be successful today if they recognize, promote and know how to use this diversity. Because the diversity of all employees with their different skills and talents opens up opportunities for in novative and creative solutions. The Aenova Group is now one of the signatories of the employer initiative "Diversity Charter" since the end of the year 2021. The Aenova Group currently employs around 4,200 people from 53 nations at its 16 sites worldwide, almost equal numbers of women and men, across a wide range of educational, hierarchical and age levels. "We are pleased that by signing the 'Diversity Charter' we can now demonstrate even more clearly our understanding of diversity in our company, which we have already been living on a daily basis for a long time," explains Marcella Spagnuolo, Vice President Corporate HR International and responsible for the "Diversity Charter" at Aenova. "Our goal is to implement our values-driven culture, based on respect and appreciation, even deeper within the company," comments Tim Bauer, Senior Vice President Corporate HR at Aenova Group. "This started last year with our values rollout and will continue with a wide variety of HR measures, such as our new feedback and development processes, to ensure our employees can best develop their diverse skills and talents." The "Diversity Charter" is an employer initiative to promote diversity in companies and institutions. The aim of the initiative is to promote the recognition, appreciation and inclusion of diversity in the world of work in Germany. Organizations should create a working environment that is free of prejudice and all employees should be valued - regardless of age, ethnic origin and nationality, gender and gender identity, physical and mental abilities, religion and worldview, sexual orientation and social origin. Since 2010, the initiative has been supported by the non-profit association Charta der Vielfalt e. V. Many well-known large corporations, medium-sized companies and other institutions are among the signatories. "At Aenova, we are convinced that living diversity and valuing it has a positive impact on the organization and on society," sums up Tim Bauer. For more information on the "Diversity Charter," visit <a href="http://www.charta-der-vielfalt.de">www.charta-der-vielfalt.de</a> .

Aenova´s Innovation Approach: Interview with CEO Jan Kengelbach in US Life Sciences Report 2022

20/05/2022 - Innovation Approach at Aenova: Interview with CEO Jan Kengelbach in US Life Sciences Report 2022

Starnberg, 20/05/2022

In the latest edition of Global Business Reports' renowned US Life Sciences 2022 Report, Aenova outlines its technology and innovation strategy. In the interview, Aenova CEO Jan Kengelbach explains the focus on leading edge technologies and the importance of deep strategic partnerships with customers:
"(...) Recently, Aenova has focused on bringing in new, differentiating technologies. None of these are new to humankind, but for many it is the first time they are offered on a CDMO platform of our size. Many are related to enhanced bioavailability of the drugs. We have several projects in our high potency area, particularly in oncology, where we take injectable drugs and try to convert them into solids by applying innovative technology and drug formulation concepts. We also offer sophisticated over-encapsulations, in which we can put an immediate and sustained release tablet in a capsule to design the therapeutic effect of different molecules. Aenova has also built a dry powder inhaler platform and can make micro-dosed filling comprised of tiny quantities of the API down to the microgram. As the second largest softgel capsule player worldwide, we see increased demand for microcapsules, softgel capsules the size of the head of a needle. These are only few examples of innovative technologies Aenova can offer its clients.
With these technologies, the company has gained access to a new set of customers willing to co-invest in these projects with us. The problem with many large-scale providers is they do primarily older lifecycle products, but we are clearly committed to bringing newer lifecycle products to life. (...)"
Read more in the <a href="https://projects.gbreports.com/united-states-life-sciences-2022/aenova-group-interview" target="_blank">US Life Sciences 2022 Report</a>.

Apprenticeship at Aenova

17/05/2022 - Apprenticeship at Aenova

Tittmoning, 17/05/2022

Finally, trade fairs can take place in presence again!
Our HR team and trainees at the site in Tittmoning in southern Bavaria were also happy about this. At the training fair "Ausbildungsroas" in nearby Traunreut, they were live on site with trainees and were able to inform interested pupils from the region about the diverse training opportunities and career paths at Aenova. The Aenova site in Tittmoning is Competence Center for conventional solids with very high volumes. Aenova, as the world's leading contract developer and manufacturer for the pharmaceutical and healthcare industries, provides training at the Tittmoning site in the following professions:
<ul><li>Laboratory (chemical laboratory technician)</li><li> Production (pharmaceutical technician, machine operator)</li><li> Administration (industrial clerk, IT specialist)</li><li> Logistics (warehouse logistics specialist)</li><li>Technology (electrician, industrial mechanic)</li></ul>
Contact us now if you would like to find out more about training and your career opportunities with us.
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Aenova achieves silver medal in EcoVadis sustainability rating

10/05/2022 - Aenova achieves silver medal in EcoVadis sustainability rating

Starnberg, 10/05/2022

Aenova, globally leading contract development and manufacturer for the pharmaceutical and healthcare industries, has achieved silver status in the latest EcoVadis sustainability rating. This documents the Aenova Group's continuous improvement of its sustainability in the categories "environment", "labor and human rights", "ethics" and "sustainable procurement".
Certified proof of sustainability in the areas of environment, labor, ethics and procurement is becoming increasingly important for companies and their suppliers. Almost half of the world's leading pharmaceutical companies use the EcoVadis assessment for this purpose. The Aenova Group also submits to the annual EcoVadis assessment and scored this year with a significant improvement from bronze to silver medal. In the areas of environment and labor and human rights, the best results were achieved with 70 out of 100 maximum possible points. With a percentile of 84, Aenova is among the top 25 percent of companies assessed by EcoVadis.
"The production steps in the pharmaceutical industry are energy-intensive. Our good result also distinguishes our responsible approach to natural resources," explains Dr. Pedro Diaz-Kraus, Vice President Corporate HSES and responsible for the EcoVadis project at Aenova. "We are very pleased that we have now been able to improve our sustainability score from bronze to silver!" "Sustainability is not an empty phrase for us, but an important strategic goal," says Jan Kengelbach, CEO of Aenova Group. "Our sustainability strategy always includes further optimization in sustainability and environmental topics. For example, the Aenova site in Sisseln already operates completely CO2 -free, many sites have photovoltaic systems as well as special wastewater treatment or their own combined heat and power plants, and we are continuously expanding the sites." The EcoVadis methodology covers a total of seven management indicators, comprising 21 sustainability criteria in four thematic areas: Environment, Labor and Human Rights, Ethics and Sustainable Procurement. It is based on leading standards such as GRI (Global Reporting Initiative), UNCC (UN Climate Change) and ISO 26000, and is overseen by an international scientific committee. It evaluates companies' performance by analyzing policies, measures and results. For Aenova, the next rating is due in early 2023.

Interview with Actif´s Magazine: How Aenova develops vegan softgel capsules

03/05/2022 - Interview with Actif´s Magazine: How Aenova develops vegan softgel capsules

Starnberg, 03/05/2022

The latest Actif's Magazine features an interview with Michael Ammann, Head of Business Unit Softgel Capsules at Aenova, about the development of Vegan Softgel Capsules at Aenova.
The new generation of Aenova VegaGels® are plant-based and a pioneering further development of their current technology. The new VegaGels® are heat and temperature resistant and very stable. This significantly reduces stickiness and cross-linking reactions during prolonged storage. The new VegaGels® are characterized by their flexible and soft texture and availability in many different variations in sizes, shapes and colors.
Aenova is globally #2 for Softgels.
Read more in the exciting interview with the magazine's editor Philippe Millet: <a href="https://www.aenova-group.com/content/news/Aenova_Softgels_Interview_Actifs-Mag_042022.pdf">Actifs Magazine, April 2022, Interview Aenova Softgel Capsules</a>
For more information about <a href="http://www.editionsbgm.fr/" target="_blank">Actif´s Magazine</a>.

Aenova invests in new building for the production of highly potent drugs

08/04/2022 - Aenova invests in new building for the production of highly potent drugs

Regensburg, 08/04/2022

Aenova has laid the foundation for the new building for highly potent active ingredients at its Regensburg site. Highly potent drugs, especially against cancer, are produced in the new manufacturing facilities. With an investment of around 10 million euros, Aenova will thus be able to significantly increase production capacity to meet increased market demand.
Cytotoxics and cytostatics continue to experience increased demand in the global pharmaceutical market. To meet this growing demand, Aenova, global leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, is building a new facility at its Regensburg site. The investment of around €10 million will enable the company to significantly expand the production in the field of highly potent active ingredients and, in particular, cancer drugs. The foundation slab for the new building was poured in March 2022.
The Aenova site in Regensburg has been developing and producing tablets and capsules with highly potent active ingredients such as methotrexate, hydroxycarbamide, azathioprine, imatinib on the former von Heyden site since the 1950s. The new four-story building with a total building area of over 4,000 m² will include not only bulk production and packaging of highly potent drugs, but also the associated laboratories, development, warehouses and social rooms. This not only means a significant expansion of the production area and the so-called white areas of development and laboratory to over 300 m² at the Regensburg site. After the planned start of operations at the beginning of 2023, the manufacturing capacities can thus be increased in volume by significantly more than 1 billion tablets and capsules. An entire floor is also reserved for flexible customer requests for "on demand" production, so that existing as well as new customers can be individually supported in line with their requests. "With this expansion, we are achieving our goal of strengthening the Regensburg site as the "Competence Center HPAPI & Oncology Products" within the Aenova Group," explains Oliver Schmied, Managing Director at the Aenova site in Regensburg. "After all, this will not only enable us to better serve market needs and customer requests, but above all to reliably provide essential medicines for patients suffering from cancer worldwide."
"Within the overall investments of the Aenova Group, the new building for highly potent active ingredients in Regensburg is an essential strategic building block. In line with our motto "Excellence beyond Manufacturing", we want to be a reliable and agile partner for our customers in key market segments," comments Jan Kengelbach, CEO of Aenova Group. The new building is scheduled for completion in summer 2022 and occupation in fall 2022. This will be followed by the installation of the laboratories and the new "on-demand" GMP area. Additional customer orders can be produced from 2023.
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_New_Building_RGB_Sketch.jpg" data-image="545856" alt="New Building high potent drugs Regensburg"><figcaption>Sketch of the new building at the Aenova site in Regensburg for the production of highly potent drugs (Sketch: Immo GmbH).</figcaption></figure>

Aenova strengthens HR with Tim Bauer as Senior Vice President Corporate HR

31/03/2022 - Aenova strengthens HR with Tim Bauer as Senior Vice President

Starnberg, 31.03.2022

Tim Bauer has been the new Senior Vice President (SVP) Corporate Human Resources at Aenova's Starnberg site since September 2021. He is responsible for all human resources tasks for around 4,200 employees at the 16 locations of the Aenova Group worldwide. His first task is to strengthen the Aenova Group as an employer brand.
Since September 2021, Tim Bauer has been Head of Corporate Human Resources at the Aenova Group as SVP and a member of the Executive Leadership Team (ELT). His tasks include strengthening the employer brand of the Aenova Group with suitable measures and thus to increase the attractiveness of the company as an employer. Within a short period of time, Bauer launched the initiative "Our Aenova Values", which manifests the customer- and service-oriented mentality and the quality standards of the Aenova Group, internationally at all manufacturing sites of the pharmaceutical contract manufacturer.Based on his many years of management expertise, including international experience, Tim Bauer relies on the personal interview as an important tool in HR work. Therefore, he attaches great importance to structured discussions between employees and supervisors to evaluate performance and potential. In addition, Aenova also uses 360-degree feedback. Training needs, internal talent management and succession planning for high-potential employees in key strategic positions are based on the results obtained with both instruments. Tim Bauer has also already further developed recruiting at Aenova. "Despite modern tools such as artificial intelligence (AI), personal contact is essential for assessing talent and building trust," Tim Bauer is convinced, adding, "A structured onboarding process is equally essential to facilitate a new team member's entry and integrate them successfully and satisfactorily as quickly as possible." The conversion of remuneration to salary bands that will be based on international salary studies is also on his agenda. Jan Kengelbach, CEO of the Aenova Group, summarizes the work of the new Senior Vice President Corporate HR so far: "With Tim, we were able to gain an excellent HR professional who has already set first milestones within a few months. With his help, we will be able to succeed in the competitive market of talent and shape a motivated and dedicated team to position Aenova as an Employer of Choice."

Aenova site Kirchberg in Switzerland introduces comprehensive ISO environmental management system

29/03/2022 - Aenova Kirchberg introduces comprehensive ISO environmental management system

29.03.2022

Aenova, global leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, is expanding environmental certifications. At the end of 2021, the Aenova site in Kirchberg (SG, Switzerland) successfully passed the ISO14001:2015 certification, documenting its comprehensive environmental management.
The Aenova Group's production site for soft gelatin capsules in Kirchberg, Switzerland (Swiss Caps AG, Member of the Aenova Group) has been practicing an effective management system for many years to reduce the impact of the plant on the environment. Especially because of the plant's specialization in highly active pharmaceutical products, effective environmental management is of great importance. In order to further improve this environmental management system and to demonstrate the performance to employees, the community, the authorities and last but not least to customers, a certification according to the ISO14001:2015 standard was sought.
In an audit lasting almost a week at the end of 2021, the inspectors were able to demonstrate the complete functionality and conformity of the comprehensive environmental management system at Aenova in Kirchberg. This led to the official award of the ISO14001:2015 certificate at the end of 2021. "The production steps in the pharmaceutical industry are energy-intensive. With our environmental management system, we can now control even better that natural resources are conserved," explains Jochen Niethammer, Head of Technical Affairs and responsible for the ISO certification.
The certification underscores Aenova's efforts to continuously improve the defined environmental performance targets. For example, Aenova's Kirchberg site has now switched its electricity supply completely to "green" hydropower and plans to install a large photovoltaic system before the end of 2022. Among other things, this will supply electricity to newly installed charging stations for electric cars and thus further motivate the workforce to use e-mobility.
"The Aenova site in Kirchberg has many years of expertise in the development and production of soft gelatin capsules, especially of highly potent active pharmaceutical ingredients for sometimes vital medicines. We are aware of this responsibility to patients worldwide on a daily basis. By obtaining the ISO environmental certificate, we are also demonstrating an ongoing development of our responsibility in environmental issues," says Dr. Christian Luftensteiner, Managing Director at the Aenova site in Kirchberg. 
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Kirchberg_ISO-Team.jpg" data-image="545552" alt="Aenova Kirchberg ISO 14001:2015 Zertifizierung"><figcaption>The certification team at Aenova's Kirchberg site proudly presents the ISO 14001:2015 certificate achieved (Photo: Aenova)</figcaption></figure>