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Starnberg

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>.

Tittmoning

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.
Tel. +49 8683 895 0 
E-Mail. <a href="mailto:azubi@aenova-group.com">azubi@aenova-group.com</a>

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>.

Regensburg

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."

Kirchberg

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>

Target reached! Joint Aenova donation of 100.000 € for Ukraine

22/03/2022 - Target reached! Joint Aenova donation of 100.000 € for Ukraine

Starnberg, 22/03/2022

Within just two weeks, the Aenova Group has reached the set joint donation target of €100,000 to support Ukraine. "With this campaign, we were able to make a significant contribution very quickly to support the people affected by the war in Ukraine. Every help is important here!", explains Jan Kengelbach, CEO of Aenova. On the specially set up <a href="https://www.aktion-deutschland-hilft.de/de/aktiv-helfen/interaktiv-helfen/starte-deine-spendenaktion/meine-spendenaktion/?cfd=whmx4&cfi=n#cff" target="_blank">Aenova Ukraine donation portal</a>, employees were able to donate directly to "Aktion Deutschland hilft". Every contribution received there was doubled by the Aenova Group. "Our joint fundraising campaign has shown how significant each individual contribution is and how strong we are as a group at the same time. "Everyone matters" and "Stronger as a group" are also two core values of the Aenova Group. The commitment of our employees is outstanding. A very big thank you to everyone for their contribution and help," comments Jan Kengelbach. "We are now looking at other ways to help, for example to provide concrete support for refugees from Ukraine," Kengelbach added.

Gronau

New Managing Director at the Aenova Site in Gronau

16/03/20221 - New Managing Director at the Aenova Site Gronau

Gronau, 16/03/2022

Welcome to Aenova: we would like to introduce our new Managing Director at the Gronau site, Dr. Frank Küpker.
Mr. Küpker looks back on a long career with well-known companies in the pharmaceutical industry. Mr. Küpker is a licensed pharmacist and has extensive experience in the production and technology of all common dosage forms.
Mr. Küpker follows Emil Wolf, who has changed to the Aenova site in Münster as Managing Director.
Within the Aenova network, the Gronau site stands out as Competence Center for freeze-dried sterile goods and conventional solids.
The Aenova site in Gronau has special expertise in the development, production and packaging of tablets, suppositories and sterile liquids.
The site can look back on more than 100 years of history in the field of pharmaceutical production and development.
The Gronau site manufactures solid forms, sterile forms, suppositories and rectal suspensions, packaged in blisters, bottles, ampoules and vials and offers quality services such as analytical & microbiological testing; stability studies according to ICH guidelines, development and testing of packaging components, PQR as well as galenical & analytical development; manufacturing / packaging / distribution of clinical studies, handling of narcotics (approval).

100,000 € as a common goal: Aenova donation initiative for Ukraine

07/03/2022 - 100,000 € as a common goal: Aenova donation initiative for Ukraine

Starnberg, 07/03/2022

Every day we can see in the news what unimaginable suffering the war brings to the people in Ukraine. As the Aenova Group, we want to and can help.
In accordance with our corporate value "Together we are strong", we want to make a significant contribution. We have set ourselves the goal of donating 100,000 euros together. Everyone can make a contribution now on <a href="https://www.aktion-deutschland-hilft.de/de/aktiv-helfen/interaktiv-helfen/starte-deine-spendenaktion/meine-spendenaktion/?cfd=whmx4#cff" target="_blank">the Aenova Ukraine donation portal</a>. The donation will go directly to the campaign "Aktion Deutschland hilft / Germany helps", which supports the most important aid organizations working in Ukraine. Aenova Group will double every contribution made on this page. Every contribution counts according to the Aenova value "Everybody counts". The organizations from the alliance "Aktion Deutschland Hilft" help those affected by the war e.g. with food, tents, medicine and other urgently needed relief supplies. They also provide medical assistance and psychosocial support. Here you can donate directly: <a href="https://www.aktion-deutschland-hilft.de/de/aktiv-helfen/interaktiv-helfen/starte-deine-spendenaktion/meine-spendenaktion/?cfd=whmx4#cff" target="_blank">Link to Aenova Ukraine donation portal</a> Thank you for your support and help!

Aenova presents investment strategy 2022 to 2025

02/03/2022 - Aenova presents investment strategy 2022 to 2025

Starnberg, 02/03/2022

Aenova, global leading development services provider and contract manufacturer for the pharmaceutical and healthcare industries, presents its investment strategy for 2022 to 2025. The focus is on major investments to expand capacity in the area of solids, to expand capacity in the area of sterile technologies for prefilled syringes, fill & finish of vaccines and the processing of biologics, and to increase capacity for highly potent active ingredients up to OEB 5. Aenova thus strengthens, among others, the product areas sterile products, oncological preparations as well as hormones and biological active ingredients.
Outstanding CDMOs (Contract Development & Manufacturing Organizations) not only offer their customers from the international pharmaceutical and healthcare industry quality and delivery reliability, but are also trusted partners throughout the life cycle of the product. This means anticipating market needs, offering flexible solutions and providing individual services.
Aenova is positioning itself with major investment projects in the years 2022 to 2025 precisely in this direction in order to be the partner of choice for its customers. The approximately 250 million euro investment package for the years 2022 to 2025 comprises various sub-projects. The focus is on significant capacity expansions for the areas of oncology and sterile manufacturing of biological active ingredients (particularly BSL1 and BSL2 vaccines) as well as in the area of high-volume standard solids.
These include:
<ul><li>Expansion of production capacity for solid dosage forms at the Tittmoning site to up to 10 billion tablets per year. The new production building covering more than 3,100 square meters has been completed, the cleanroom interior has been finished and the production equipment has been brought in. The new building was commissioned in the fall of 2021. </li><li>Massive expansion of capacities for solids production in the area of highly potent, cytotoxic products (up to OEB 5) at the Regensburg site. The foundation stone for the new building will be laid in the first quarter of 2022, and GMP-compliant production is planned for 2023.</li><li>Capacity expansion at the semi-solida site in Carugate. A new high-speed liquid line will start up in the second quarter of 2022, followed by a new high-speed tubes line in 2023.</li><li>Expansion of coating and bulk capacities for the production of oral solid dosage forms for penicillin production at the site in Latina, Italy, and massive capacity expansion for intramammary syringes in the Animal Health business.</li><li>New sterile area for filling of biologics, prefilled syringes and fill&finish of vials with mRNA vaccines at the Latina site in Italy. The large facility will go into operation with a first customer project in the first quarter of 2022.</li><li>Expansion of capacities for the sterile production of up to 100 million ampoules and vials per year at the Gronau site. The new line, now the sixth at the site, was commissioned in 2021.</li><li>Capacity expansion in the production of high potent bulk for softgel capsules and expansion of packaging capacities at the Kirchberg site in Switzerland.</li><li>Establishment of a Dry Powder Inhaler platform for several customer projects with planned launch in 2023 and 2024.</li></ul>
<h5>One-stop-shop for all common dosage forms and modern products</h5>
With this major investment program, Aenova is positioning itself as a future-oriented service partner for its customers across all 15 manufacturing sites. Through the three Business Units Solids, Semisolids & Liquids and Softgel Capsules, Aenova is placing itself as a one-stop store from development to scalable high-volume production and packaging services. A special customized offering is the "plant in plant" approach, where Aenova provides its customers with agile solution developments already in the first preliminary phase of a project. Specialized knowledge, such as on demanding release profiles or increased bioavailability, rounds out the offering profile.
<h5>Strengthening market position as leading CDMO</h5>
Under the motto "Excellence beyond Manufacturing", Aenova offers the highest quality at consistently high on-time delivery times. The majority of Aenova's sites have EU GMP or FDA and Anvisa approval. With the new investments, Aenova continues to evolve into a provider of differentiated technologies and development capabilities, both for small molecules and biologics. "With this holistic investment approach, we provide our customers with a future-proof technology portfolio, which is already positively reflected in many notable orders for the coming years. This strengthens Aenova's ambition to be among the top 5 CDMOs worldwide by 2025," explains Jan Kengelbach, CEO of Aenova..
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Latina_Sterile_02032022.jpg" data-image="545196" alt="Aenova Latina Sterile Aerea Detail"><figcaption>New sterile area for filling biologics at Aenova's Latina site. Photo: Aenova</figcaption></figure>

Aenova rated as an employer with "very high attractiveness"

15/02/2022 - Aenova rated as an employer with "very high attractiveness"

Starnberg, 15/02/2022

In the study "Germany's Best Employers", Aenova receives the rating "Company with very high attractiveness" in the category "Industry". More than 800,000 citizens in Germany were surveyed about a total of almost 4,000 companies - including Aenova. According to this research, Aenova has an above-average public image. The study results were published at the end of 2021 in the newspaper WELT, among others.
Finding and retaining skilled workers is now crucial to success in numerous industries. When selecting an employer, good and suitable employees no longer focus solely on salary, but also on factors such as development opportunities, sustainability and image. A nationwide study commissioned by the newspaper WELT investigated how companies in Germany are perceived by the public and can thus gain a competitive advantage as an employer. The results of which were published at the end of 2021.
<h5>Aenova achieves highest rating</h5>
As part of the study, over 800,000 German citizens were surveyed about a total of 3,953 companies from the service, retail and industry sectors. The basis of the population survey on employer attractiveness was the question of personal perception of the image or attractiveness of the employers under investigation. The respondents did not have to be in an employment relationship with the respective companies, but could also take an external view. The investigators' central question to the respondents was: "How do you rate the company's image or attractiveness as an employer?" The evaluation was based on a 5-point response scale from 1 ("excellent") to 5 ("poor"). An unweighted median value was calculated for each company from these values. The results were published in the November 1, 2021 issue of WELT, among others. The study was conducted by the Cologne-based rating and ranking agency ServiceValue GmbH in cooperation with WELT.
The Aenova Group performed very well in the "Industry" category of this survey and received the "Employer with Very High Attractiveness" award, which is the highest rating granted in the study. "How we are perceived by the public as an employer is very important to us," explains Tim Bauer, Senior Vice President Corporate HR at Aenova Group. "The excellent result contributes to all the employer branding issues planned at Aenova in the upcoming months." The management board is also very satisfied. "The impressive result in an independent survey illustrates that Aenova has a high reputation overall in Germany. This is also reflected in personal contacts with customers and partners," comments Jan Kengelbach, CEO of the Aenova Group, on the survey results. "We are very pleased about this award, but we also see it as an encouragement to become even better every day."
The "Germany's Best Employer" seal of approval represents independent proof of quality and promotes awareness and positive perception of the award-winning company.
For more information on the study, please visit
<a href="https://www.servicevalue.de/ranking/deutschlands-beste-arbeitgeber-welt">https://www.servicevalue.de/ranking/deutschlands-beste-arbeitgeber-welt</a>.

Aenova becomes a participant of the UN Global Compact for sustainable and responsible corporate governance

11/02/2022 - Aenova becomes a participant of the UN Global Compact

Starnberg, 11/02/2022

The Aenova Group is now one of the signatories of the UN Global Compact, a worldwide initiative for sustainable and responsible corporate governance. By participating in the UN Global Compact, Aenova supports the principles and goals of the initiative, to which more than 19.000 companies worldwide and more than 740 in Germany already belong. Aenova's commitment to the UN Global Compact highlights the importance of human rights, labor standards and environmental protection in the company's medium- to long-term orientation.
Since the end of 2021, the Aenova Group has been a so called signatory participant in UN Global Compact. By participating in the worldwide initiative, Aenova indicates to embed the central principles and goals of the UN Global Compact as guidelines in the CSR strategy.
The ten universal principles to which companies participating in the UN Global Compact are committed include:<ul><li>Support and respect for international human rights</li><li>Compliance with international labor standards, including the avoidance or elimination of forced labor, child labor and all forms of discrimination</li><li>Consequences of the precautionary principle in dealing with the environment and environmental problems, as well as the promotion of general environmental awareness</li><li>Development and dissemination of environmentally friendly technologies</li><li>Advocacy against all forms of corruption</li></ul>
Aenova's participation in the recognized international network reflects its intention to make the UN Global Compact and its principles part of the company's strategy, culture and daily work, thus promoting sustainable development goals of the United Nations. "We are very pleased that by joining the UN Global Compact we can now pursue our core values and CSR goals in an even more focused and sustainable way," comments Jan Kengelbach, CEO of Aenova Group. "As a globally active contract development and manufacturing organization with strong roots in Germany, we and our approximately 4,300 employees worldwide will now be able to contribute even more effectively to achieving these goals in the future," Kengelbach added. "The annual reporting to the initiative on developments and progress regarding its principles and goals provides sustainability, which we explicitly promote and whose challenges and responsibility we are very happy to face." For more information on the UN Global Compact, visit <a href="http://www.unglobalcompact.org/">www.unglobalcompact.org.</a>
<a href="http://www.globalcompact.de/"></a>

Bad Aibling

Aenova trainees help the needy at the Bad Aiblinger Tafel advent campaign

Bad Aibling, 17/12/2021

The Bad Aiblinger Tafel's "One More" campaign is a pre-Christmas donation initiative that has been established for years and is supported by many local grocery stores. The additional one item more that customers buy and pass on to the Tafel goes to needy people in the region. Four trainees from Swiss Caps GmbH, a member of the Aenova Group, actively helped with this year's campaign. In times of pandemic, young people in school and training are particularly affected. Social contacts are part of their development and maturation into adulthood, and these have been particularly limited for young people over the past 20 months. But needy people also suffer from the corona-related reduced contact opportunities and the partly reduced willingness to donate. The social commitment of the young trainees therefore comes at the right moment. The aim of the purely voluntary Tafeln is to distribute food of impeccable quality, which can no longer be used in the economic process, to people in need. Under the motto "Food where it belongs", food and also goods for daily use are collected by the Tafel Bad Aibling and given to people in need. Every needy person is helped regardless of their origin, religion, nation, possibilities and limitations. Since October 2021, all trainees at the Aenova site in Bad Aibling have been supporting the Aiblinger Tafel. Regularly once a week, two trainees help on a rolling basis with the distribution of food and the compilation of food boxes. "Our trainees are committed young people who are interested in social issues and like to get actively involved. We are very pleased to be able to actively support the Aiblinger Tafel here," explains Stefanie Egger, training manager at the Aenova site in Bad Aibling. This commitment to the Tafel Bad Aibling fits very well into the company's concept of social responsibility on site: Swiss Caps GmbH has been working for a long time with the Wendestein Werkstätten, a Caritas workshop for people with disabilities, has been cooperating for several years with the job-related youth welfare organization "junge arbeit" Bad Aibling and regularly supports a children's home in Rosenheim.
("Tafel" is the name for charitable aid organizations in Germany that distribute food that is no longer used in the economic cycle and would otherwise be destroyed to those in need or give it away for a small fee.)
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Eins-mehr-Aktion_Bad-Aiblinger-Tafel_2021.jpg" data-image="543336" alt="Azubis unterstützen Bad Aiblinger Tafel"><figcaption>"One more" campaign 2021: Trainees from the Aenova site in Bad Aibling together with another supporter of the Aiblinger Tafel. (Foto: Aenova)</figcaption></figure>

Aenova Whitepaper "Cannabinoids: Therapeutic effects and the advantages of soft capsules as appropriate dosage form"

13/12/2021 - Aenova Whitepaper: The advantages of softgel capsules as a dosage form for cannabinoids

Kirchberg, 13/12/2021

Cannabinoids can provide great benefits for the treatment of cancer and central nervous system diseases. Softgel capsules are the preferred delivery form for cannabinoid products for many reasons. Aenova presents this in the new white paper "Cannabinoids: Therapeutic effects and the advantages of soft capsules as appropriate dosage form".
Cannabis has been in the public discussion for several years. This concerns the questions of legalization as well as the therapeutic use. Medicinally, cannabinoids are used in various fields of application, e.g. for neuropathic pain and spasticity, for loss of appetite in case of HIV as well as for nausea and vomiting under chemotherapy and for specific infantile forms of epilepsy. The new white paper from Aenova entitled "Therapeutic effects and the advantages of soft capsules as appropriate dosage form" first reviews the history of the therapeutic use of cannabinoids and presents the regulatory framework as well as the current state of the legal situation. A special case is the development of cannabinoid drugs for medical use. For synthetic or natural cannabinoids with a clear origin and defined specifications, clinical trials for well-defined indications have high chances of success. However, to date, there is no approved marketing authorisation application for cannabis to treat any disease or condition. This is due to the fact that cannabis itself has a complex and difficult to characterize composition. About 120 different cannabinoids are present in Cannabis sativa, Cannabis indica and Cannabis ruderalis. Only two of these are well characterized: Cannabidiol (CBD) and Tetrahydrocannabinol (THC). A look at the endocannabinoid system, the number of clinical trials and the current market situation for cannabinoids completes the presentation. Crucial in this context is the question of the appropriate dosage form of cannabinoids. For pharmaceutical purposes, several different ones have been considered for the formulation of cannabinoids: oral, nasal, sublingual, transcutaneous, rectal, etc. Oral administration is often preferred because of its ease of use and lower regulatory hurdles. Softgel capsules, on the other hand, are particularly well suited as the preferred form of administration because of their specific properties. The authors of the white paper, Dr. Mario Arangio and Dr. Christian Luftensteiner, are proven experts in the development and manufacture of softgel capsules at Swiss Caps AG, Member of the Aenova Group, at the Kirchberg site in Switzerland. With 4,300 employees, Aenova is one of the world's leading contract developers and manufacturers for the pharmaceutical and healthcare industries. The Swiss site is a center of excellence for the development and production of softgel capsules including highly potent APIs (OEB 5) and has over 35 years of experience in the formulation, analytical development and production of softgel capsules. The white paper (16 pages) can be requested free of charge at <a href="mailto:contact-sales@aenova-group.com">contact-sales@aenova-group.com</a>. <h5>Data protection information</h5>
For data protection reasons, we would like to point out that we consider your e-mail requesting the whitepaper at the above-mentioned e-mail address as consent to receive the whitepaper. By doing so, you also consent that Aenova Holding GmbH may contact you under the contact data stored in your request e-mail (e.g. in a signature) for promotional purposes for Aenova's own services. The provision of your consent is voluntary. You can revoke it at any time free of charge, for example by sending a new e-mail to contact-sales@aenova-group.com. Further general information on data protection can be found here <a href="https://www.aenova-group.com/en/privacy/privacy-policy">https://www.aenova-group.com/en/privacy/privacy-policy</a>

Latina

Aenova site in Latina, Italy, among the winners of the Premio Industria Felix

01/12/2021 - Aenova among the winners of the Premio Industria Felix

Latina, 01/12/2021

The Premio Industria Felix was awarded to the 160 best Italian companies by industry on Nov. 25, 2021 in Rome. The Aenova site in Latina, Haupt Pharma Latina S.r.l., is among the award winners. The award was presented in a ceremony at the University Luiss Guido Carli in Rome. Industria Felix recognizes the success of Italian excellence and pays particular attention to sustainability and growth. We are very pleased to be among the award winners and to see our work recognized in such an illustrious environment. You can read more here (article in Italian). <a href="https://www.ansa.it/pressrelease/economia/2021/11/30/il-premio-industria-felix-a-160-top-imprese-italiane-_578567a3-7b7c-4b10-a02f-6eb6821ce5c4.html" target="_blank">Here you can read more</a> (article in Italian language).
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/gruppo-chimiche-e-farma.jpg" data-image="543271" alt="Premio Industria Felix award ceremony in the &quot;Chemicals & Pharmaceuticals&quot; category"><figcaption>Premio Industria Felix award ceremony in the "Chemicals & Pharmaceuticals" category (Foto: IFM)</figcaption></figure>

Cornu

Interview - Managers under the spotlight: the managing director of our Cornu site

Managers under the spotlight: the managing director of our Cornu site

Cornu, 25/11/2021

The Chamber of Commerce Switzerland-Romania has recently launched the “Who’s who” series of profile interviews about the CEOs managing the member companies. In the current issue, our Managing Director of the Aenova site in Cornu, Romania, Michael Ammann, answers interesting questions about his daily work and life in an interview. Michael Ammann is also SVP of the Softgel Capsules business unit at the Aenova Group. <a href="https://www.ccer.ro/news/news-from-members/managers-under-the-spotlight-michael-ammann-swiss-caps-aenova-group/" target="_blank"> Read more.</a>

New Video: The New Sterile Area with Fill & Finish of Biologics at Aenova Latina site

23/11/2021 - New video: the brandnew fill&finish area Aenova Latina

Latina, 23/11/2021

Aenova has significantly expanded its sterile fill and finish capacity at its Italian site in Latina. The new state-of-the-art aseptic production area features a completely new high-speed flexible line for vials and prefilled syringes (PFS) as well as a brand new compounding area. This area provides capacity for more than 80 million vials and over 180 million prefilled syringes, targeting vaccines and biologics. Further capacity expansions to a total of up to four high-speed filling lines are also being planned.
Get the newest insights! Watch <a href="https://www.aenova-group.com/content/company/sites/latina/bildgalerie/Aenova_Latina_Sterile_Area_Imagefilm.mp4">the video here</a>. 
<figure><a href="https://youtu.be/ZScUPc-DV0g" target="_blank"><img src="https://www.aenova-group.com/content/navigation/_medium/New_sterile_area_Aenova_Latina_2.jpg" data-image="541925" alt="New Fill&Finish Line in Latina"></a><figcaption>New sterile area at Aenova Latina site</figcaption></figure>

Jefferies London Healthcare Conference: Video recording of the Live Presentation

19/11/2021 -  Jefferies Healthcare Conference: Video of Aenova Presentation

London, 16/11/2021

At the Jefferies Healthcare Conference from 16 to 19 November 2021 in London Aenova was participating with a presentation.
Aenova CEO Jan Kengelbach gives in his presentation an overview of the broad portfolio Aenova offers to pharma and healthcare customers, an outlook on the strategy until 2025 and current figures.
Also learn more about the essence of the Aenova claim "Excellence beyond Manufacturing".
Watch the video recording <a href="https://wsw.com/webcast/jeff201/aeno/1824426" target="_blank">here</a>.
<figure><a href="https://wsw.com/webcast/jeff201/aeno/1824426"><img src="https://www.aenova-group.com/content/navigation/_medium/Video_Play.png" data-image="543104" alt="Jefferies Video"></a><figcaption>Aenova CEO Jan Kengelbach at Jefferies London Healthcare Conference 2021</figcaption></figure>

PR Aenova capacity extension solida Tittmoning

Aenova increases production capacity for solid dosage forms at Tittmoning site to up to 10 billion tablets per year

05/11/2021 - 10 billion tablets a year: capacity expansion at Tittmoning site

Tittmoning, 05/11/2021

The investment project to expand tablet manufacturing capacity is nearing completion; routine operations will start in the second quarter of 2022. With the commissioning of the third high-volume line, production capacity at the site increases to over 10 billion tablets per year. An expansion to 12 billion tablets is possible with a short lead time. The investment of around € 25 million is in the context of further strategic projects of the Aenova Group.
Aenova is significantly expanding its production capacities for tablets at the Tittmoning site. The new 3,100 sqm production building has been completed, the clean room interior has been finished and the production equipment has been brought in. Production is scheduled to start in the first quarter of 2022. The site will then have a third production line for high-volume tablet products, expanding its total capacity to 10 billion tablets. The new line will also operate according to the established semi-continuous production concept, which combines short throughput times and proven process technology. State-of-the-art equipment together with existing know-how enables fast, successful product transfers and offers cost efficiency with consistently high product quality in routine production.
The investment project at the Tittmoning site, which provides for further expansion stages for an additional 2 billion tablets, consolidates Aenova's top position as a solid dose contract manufacturer for the pharmaceutical and healthcare industry in Europe. At the same time, the company is focusing on global expansion with the implementation of modern, international standards. Tablets and capsules are the most widely used dosage form for medicines on both the German and international markets, and demand continues to rise. "Within the Aenova Group, the Tittmoning site is the competence center for high-volume solids. After the expansion, we can serve the requests of our many customers on all continents even better," explains Christine Beck, Senior Vice President of the Solids Business Unit at Aenova. "With an annual capacity of more than 10 billion tablets in the future, we reach a new order of magnitude and with the last expansion stage, we will create more than 100 new highly modern workplaces", explains Dr. Helmut Stibich, site manager Dragenopharm Apotheker Püschl GmbH, Member of the Aenova Group. The investment volume for the first of three planned expansion stages amounts to around € 25 million. "This is one of the strategic growth projects of the Aenova Group and part of our growth strategy, which we are also implementing at other locations," explains Jan Kengelbach, CEO of the Aenova Group. Meet Aenova at CPhI worldwide from 09 to 11 November 2021 at Fiera Milano, Italy, at booth 2C20, hall 2.

<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Site-Extension_Tittmoning_external-view-zoom.jpg" alt="Aenova Tittmoning Site Extension" data-image="3yeilizvnb7w"><figcaption>With the construction of the new production building of around 3,100 sqm at the Aenova site in Tittmoning, capacities will be increased to up to 10 billion tablets. (Photo: Aenova).</figcaption></figure>

PR Aenova Probiotic softgel capsules

New probiotic softgel capsules support the health of the gut flora

25/10/2021 - New probiotic softgel capsules support the health of the gut flora

Kirchberg, 25/10/2021

The new probiotic formulations are based on a dedicated shell combined with suitable fill mass enhancers. The new capsules are easy to swallow. The capsule content can be adapted to special needs and further ingredients. Taste, colour, and size are customizable.
With its probiotic softgel capsules, the Aenova Group, a global leading contract manufacturer and developer for the pharmaceutical and healthcare industries, has developed a new product for the wellbeing of the human body at its Swiss site in Kirchberg. The new capsules, which contain living bacteria or yeasts, do combine the advantages of the soft gelatin formulation technology with the health benefits of Probiotics.
Probiotics help to restore the natural balance of bacteria in the gut when it has been disrupted by an illness or treatment. Some pathological conditions they can help with are irritable bowel syndrome, inflammatory bowel disease (IBD), infectious diarrhea (caused by viruses, bacteria, or parasites) or diarrhea caused by antibiotics.
The microorganisms, which are encapsulated under special conditions, do show activity and growth after production and storage. Therefore, viability of the contained “good” bacteria and yeasts is assured.
"Following our mission we pride ourselves on delivering innovative products and services to healthcare customers that improve and extend patients' lives”, states Dr. Christian Luftensteiner, Managing Director of Aenova’s Swiss site at Kirchberg. “In our Center of Excellence for soft capsules we apply decades of know-how and most modern infrastructure to provide impeccable quality to our customers worldwide.” Visit Aenova at the CPhI trade show in Milan, November 9 – 11, 2021, booth 2C20, hall 2.
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Probiotics_Softgels_Aenova.jpg" alt="Aenova Probiotic softgels" /><figcaption>Aenova Probiotic softgels (Photos: Aenova)</figcaption></figure>

PM Aenova Neuer Sterilbereich

New sterile Fill and Finish area for vials and prefilled syringes at Aenova

19/10/2021 - New sterile Fill and Finish area for vials and prefilled syringes at Aenova

Latina, 19/10/2021

Aenova has significantly expanded its sterile fill and finish capacity at its Italian site in Latina. The new state-of-the-art aseptic production area features a completely new high-speed flexible line for vials and prefilled syringes (PFS) as well as a brand new compounding area. This area provides capacity for more than 80 million vials and over 180 million prefilled syringes, targeting vaccines and biologics. Further capacity expansions to a total of up to four high-speed filling lines are also being planned.
This first high speed flexible line can process both vials and PFS products in the preferred formats of 0.5 to 10 ml for prefilled syringes and 2 to 10 ml for ready-to-use vials. Quality control, packaging and labelling, including serialisation, complete the scope of supply. "With this expansion of our aseptic offering, Aenova becomes a Premier Solution Partner for sterile technologies," said Florent Bordet, Senior Vice President of Aenova's Sterile &amp; Liquid Business Unit.
The Aenova site in Latina, one of the largest production sites of the Aenova Group with around 600 employees, produces and distributes pharmaceutical products worldwide. Different buildings in the facility allows to be in the market with a broad site portfolio which includes injectable and oral solids for conventional medicines. "We are very proud that with the new sterile filling line we will be able to make a major contribution to the global supply of vaccines and high-value biologics like recombinant proteins or monoclonal antibodies " explains Paolo Abbate, Managing Director of Haupt Pharma Latina S.r.l., a member of the Aenova Group.
"Aenova is thus positioning itself as a provider of differentiated technologies with development and high-volume production capacities for small molecules as well as biologics," explains Jan Kengelbach, CEO of Aenova Group. "With an investment volume of around 16 million euros, the Latina plant is one of the larger investment projects that the Aenova Group is currently rolling out," adds Jan Kengelbach.Meet Aenova at CPhI worldwide from 09 to 11 November 2021 at Fiera Milano, Italy, at booth 2C20, hall 2. <figure><img src="https://www.aenova-group.com/content/navigation/_medium/New_sterile_area_Aenova_Latina_2.jpg" alt="New sterile area in Latina" /><figcaption>Sterile production at Aenova, site Latina: fill&amp;finish of biopharmaceuticals like COVID-vaccines. (Photo: Aenova).</figcaption></figure>

PR Aenova Chewable vegan softgel capsules EN

New chewable VegaGels® with algae-based omega-3: multiple colours and flavours

23/09/2021 - New chewable VegaGels® with algae-based omega-3: multiple colours and flavours

23/09/2021

<ul><li>The new softgel capsules are based on the vegan Aenova VegaGels® and are filled with omega-3 DHA fatty acids from microalgae.</li><li>The chewable vegan softgel capsule is easy to take.</li><li>Available in Tutti-Frutti, Strawberry and Citrus flavours in a variety of colours, the DHA-rich supplement is particularly suitable for children. </li><li>The new pure vegetable omega-3 softgel capsule is a joint project of AlaskOmega AG, Algarithm and Aenova.</li></ul>
With its VegaGels®, the Aenova Group, a global leading contract manufacturer and developer for the pharmaceutical and health care industries, has already been producing vegan softgel capsules based on seaweed extract for some time. Now the VegaGels® on a purely vegetable basis are being expanded to include a chewable variant. In cooperation with AlaskOmega AG, the European subsidiary of Wiley Companies, and Algarithm, a leading Canadian company for algae DHA oils, Aenova manufactures the new vegan softgel capsules. These contain Algarithm's microalgae-based alphamega³ omega-3 DHA oil. The softgel capsules are chewable and therefore particularly easy to take. They are currently being produced specifically with children in mind. Flavours include Tutti-Frutti, Strawberry and Citrus Lemon with corresponding colours pink, red and yellow. The new composition targets the needs of consumers who follow a vegetarian or vegan diet or prefer products without animal testing and are suitable for special religious food requirements, such as kosher or halal. The new softgel capsules are compliant with the regulations for the American, European and Chinese markets. "We are delighted about this successful cooperation. It shows again that the Aenova Group is an innovative contract manufacturer that can adapt to customer requirements and market trends quickly and with flexible solutions," explains Michael Ammann, Head of the Softgel Capsules Business Unit at Aenova. "This also reflects the Aenova motto "Excellence beyond Manufacturing"! The new chewable vegan softgel capsules with algae-based Omega-3 DHA will be introduced at the Vitafoods trade show in Geneva, October 5-7, 2021. Visit Aenova at Vitafoods at booth F60.

<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Chewable_vegan_Softgels.JPG" alt="Chewable VegaGels(R)" /><figcaption>New chewable VegaGels® with algae-based omega-3 in multiple colours and flavours (Photo: Aenova)</figcaption></figure>

Our new SVP Human Resources

21/09/2021 - Our new SVP Human Resources

Starnberg, 21/09/2021

Welcome to Aenova: We would like to introduce our Senior Vice President Human Resources Tim Bauer.
Mr. Bauer previously worked for many years in HR for manufacturing companies, where he held various regional and international management and leadership positions in HR. After studying industrial and organizational psychology, he initially worked for various consulting companies and as a director at Sky Deutschland. He was then Vice President Human Resources at Vetter. Most recently, he was responsible for HR as Managing Director at Schwarz Produktion. Since September 2021, Tim Bauer has been Senior Vice President Human Resources at the Aenova Group. He is member of the Executive Leadership Team at Aenova. 
<figure><img src="https://www.aenova-group.com/content/navigation/_crop500/LinkedIn-TimBauer.jpg" alt="SVP Human Resources" /><figcaption>Aenova SVP Human Resources, Tim Bauer</figcaption></figure>

Eco Certificate for Aenova site in Cornu

13/08/2021 - Eco Certificate for Aenova site in Cornu

Cornu, 13/08/2021

Aenova at the site in Cornu, Romania, now received a Certificate on Greenhouse Gas Emission Reductions for 2020. This certificate was issued based on the calculations made by the environmental engineers of the environmental consulting firm "Eco Synergy" on the packaging waste generated by Swiss Caps Romania, member of the Aenova Group, during 2020 and recycled/valorized by Eco Synergy. The joint action of Aenova in Cornu has contributed to the reduction of 415 tons of CO2 emissions into the atmosphere, representing the saving of 2072 trees. This is another building block in the Aenova HSES strategy and reflects Aenova's claim: Excellence beyond Manufacturing!
<figure><img src="https://www.aenova-group.com/content/navigation/_crop500/Cert_cornu_5.png" alt="New Eco Certificate, Aenova site Cornu" /><figcaption>New Eco Certificate, Aenova site Cornu</figcaption></figure>

PR Aenova Cooperation Wendelstein Workshop

"Sticking together despite the distance":
Swiss Caps and Wendelstein Werkstätten also cooperate during the pandemic

Continued cooperation with workshop for people with disabilities even in times of pandemic

Bad Aibling, 28/07/2021

The Corona pandemic posed particular challenges to the world of work and society over the past 15 months. This also applied to the proven cooperation between Swiss Caps GmbH, Member of the Aenova Group, in Bad Aibling and the Wendelstein Werkstätten. But the pharmaceutical company and the workshops for people with disabilities quickly found suitable solutions to continue the cooperation. Aenova is one of the world's leading contract developers and contract manufacturers for large national and international pharmaceutical and food supplement companies. The Bad Aibling site produces and packages tablets, coated tablets, hard capsules and above all effervescent products with around 400 employees. Thanks to early and strict COVID-19 measures throughout the Aenova Group, the production of important medicines for patients worldwide could be ensured without interruption. The cooperation with the Wendelstein workshops had to be adjusted due to corona. Employees of Wendelstein Werkstätten have been providing support to Swiss Caps GmbH in the areas of packaging, laboratory, warehouse/logistics, cleaning and metal workshop for 14 years. Due to the corona-related contact restrictions, the work on site was initially scaled back, but there were quickly talks between Swiss Caps and Wendelstein Werkstätten for a concept called "Zamrucka despite distance". This enabled the Swiss Caps team at Wendelstein Werkstätten to resume work in February 2021. With flexibility and ingenuity, the "Wendelsteiners" were offered pandemic-compliant opportunities that matched their skills and inclinations. The "cleaning team" was quickly able to resume work on its own responsibility and thus make an important contribution to infection control. In the in-house metal workshop, a former metal worker was able to contribute his extensive knowledge and skills for the production of mouth guard dispensers for the entire changing and production area of Swiss Caps GmbH. "For us as a company, respect and mutual appreciation are essential values. This also includes that people with disabilities can be integrated into working life," explains Thomas Lemke, Managing Director of Swiss Caps GmbH. "We are very pleased that we are able to maintain the cooperation over such difficult times and that Swiss Caps is so committed," add Michaela Paul, group management and integration support, and her colleague Hermann Rudolph, group service employee, from Wendelstein Werkstätten. The creative solution finding during the Corona pandemic illustrates how inclusion in working life can succeed. The Aenova site in Bad Aibling also stands out for its social commitment in the region. In the last twelve months, a four-digit donation was handed over twice to a children's home in Rosenheim. <figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_BAA_Wendelstein_Werkstaetten.jpg" alt="Cooperation with workshop for people with disabilites" /><figcaption>Successful "Sticking together despite the distance" by Swiss Caps GmbH and Wendelstein Werkstätten: the cleaning team was able to restart quickly despite the pandemic. (Photo: Aenova)</figcaption></figure>

PR Aenova Cornu new bottle line EN fw

One-stop shop CDMO Aenova: production and packaging of softgel capsules from a single source

20/07/2021 - One-stop shop CDMO : production and packaging of softgel capsules from a single source

20/07/2021 - Cornu

Aenova produces and packages soft gelatin capsules and vegan soft capsules as a contract manufacturer for large, international pharmaceutical and nutritional supplement companies at its Cornu, Romania site with its subsidiary SWISSCAPS Romania s.r.l.. With the production of various dosage forms of pharmaceuticals and food supplements, the Aenova Group is one of the leading contract manufacturers and developers in Europe and worldwide (Contract Development and Manufacturing Organisation, CDMO). A new can and bottle filling plant has now been commissioned in Cornu, which can fill around 12 to 14 million plastic or glass bottles per year. At Aenova in Cornu, up to 10 billion softgel capsules are produced annually and can be packaged in blisters and cans or bottles. These include not only soft gelatin capsules for pharmaceuticals as well as dietary supplements, but also Aenova's vegan VegaGels®. With the newly installed filling line, the capacity of the packaging department with can and bottle filling will be significantly expanded. Aenova at the Cornu site is thus establishing itself as a "one-stop shop" for the production and packaging of soft capsules in all common variants and on customer request. The new line packs in bottles with a diameter of 44 to 76 mm and a height of 55 to 165 mm, made of glass or plastic, with screw cap or so-called press lid. Special bottles can also be filled on request. For secondary packaging, all common variants of cardboard packaging with or without package insert including shrink film packaging and labeling are possible. "The advantages of the "one-stop shop" for customers are obvious: with a competitive price, customer companies receive production and packaging from a single source, have only one contact person and only one manufacturing plant to qualify and register," explains Michael Ammann, Senior Vice President of the Softgel Capsules Business Unit and Managing Director at the Cornu site. This not only significantly reduces lead time, but also the overall on-time delivery (OTD). OTD at the Aenova site in Cornu is excellent at around 95%. "This means real added value for our customers," sums up Ammann.
<figure style="float:left;width:400px;max-width:400px;margin-left:10px;margin-right:10px;"><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_IMA_filler_hr.jpg" alt="Production and packaging of soft capsules from a single source at the Aenova" /><figcaption>Production and packaging of soft capsules from a single source at the Aenova site in Cornu, Romania</figcaption></figure>

Aenova publishes Annual Report 2020

05/07/2021 - Aenova publishes Annual Report 2020

Starnberg, 05/07/2021

Aenova publishes its 2020 Annual Report today. The report summarises the business and highlights for 2020 and gives insights into the company’s strategy.
Learn more about Aenova's 2020 achievements and milestones, as well as key events in each business unit. Read <a href="https://www.aenova-group.com/content/Aenova_Annual_Report-2020.pdf" target="_blank" rel="noreferrer noopener">more</a>.

PR Aenova Quality Nitrosamine EN

Nitrosamine regulation implemented on time for many customers thanks to modular solution approach of Aenova

28/06/2021 - Nitrosamine regulation implemented on time thanks to modular solution approach of Aenova

Starnberg, 28/06/2021

<ul><li>Aenova developed a comprehensive process and solution approach for marketing authorization holders.</li><li>Already within the first regulatory deadline, all risk assessments for customers could be prepared.</li><li>The deadline extension for biologic drugs expires July 1, 2021.</li></ul>
After the regulatory authorities had already become aware of products containing valsartan in July 2018, the worldwide recall of medicines containing metformin also attracted great attention just over a year ago. The reason for this was a contamination with carcinogenic nitrosamines. In a report, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) called on companies to take actions to limit the presence of nitrosamines in medicines for human use as far as possible and to ensure that the strict limits are not exceeded. This posed a particular challenge, first for API manufacturers, then for marketing authorization holders, as well as for contract manufacturers working for pharmaceutical companies. Within a short period of time, the Aenova Group, as the world's leading contract developer and manufacturer for pharmaceutical and healthcare companies, was able to implement a comprehensive, scientifically based modular solution for risk assessments, both in terms of content and process, and to execute this together with the customer companies for their products.<h5>The first specifications of the EMA</h5>
In the interest of patient safety, marketing authorization holders were made responsible by the EMA to review their manufacturing processes, first for all products containing chemically synthesized active ingredients and later also for biological active ingredients, in order to identify and mitigate the risk of nitrosamine contamination where applicable. Similarly, strict nitrosamine limits were set for products. Furthermore, for all affected products marketing authorization holders needed to also implement appropriate control strategies and to further improve manufacturing processes where necessary.The risk assessment of all products should be completed at the latest within six months after the publication of the "Information on Nitrosamines for Marketing Authorization Holders". Thereupon, the authorization holders were to inform the competent authorities when the risk assessment was completed. For this purpose, an initial deadline of 26.03.2020 applied. In the course of last year, this had to be extended initially until 01.10.2020, then again until 31.03.2021 due to the COVID19 pandemic, and applies to biological medicinal products until 01.07.2021. Aenova was able to complete all risk assessments for its own customers on time by the first deadline. Thanks to the flexible, modular structure of the Aenova approach, it can also be modified for biological medicinal products. 
Read more in our current press release.

Crypto codes: special serialization for the Russian market

01/06/2021 - Crypto codes: special serialization for the Russian market

01/06/2021

When it comes to serialization of pharmaceuticals and dietary supplements, crypto codes are a special requirement for the Russian market.Since July 1, 2020, every drug offered for sale on the Russian market must be serialized using crypto-code. Strict requirements apply to the print quality of the code. Complete traceability and protection against counterfeiting of the products produced by means of serialization is mandatory. The basic prerequisite for counterfeit-proofing of a product is the unique assignment of a serial number in conjunction with individual production data (product identification GTIN/NTIN/PPN, expiry date, and batch number) in the form of a data matrix code. This is used to mark the folding boxes of the respective medicines or food supplements. Aenova offers a secure solution.
Learn more in the following article (in German language) in <a href="https://www.pharma-food.de/ausruestung/verpacken-kennzeichnen/serialisierungs-aufdrucke-fuer-den-russischen-markt-373.html" target="_blank" rel="noreferrer noopener">"Pharma+Food"</a>.
<figure style="float:left;width:876px;max-width:876px;margin-left:10px;margin-right:10px;"><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Serialisierung.JPG" alt="Proper ink enables secure serialization of the special crypto codes" /><figcaption>Pharmaceutical packaging for the Russian market must be serialized with crypto-code. Foto: BOWA</figcaption></figure>

BIO Digital virtual conference

31/05/2021 - BIO Digital virtual conference with special topics in times of pandemic

Online, 10.-11./14.-18.06.2021

<h5>Special topics in times of pandemic: vaccines take center stage</h5>
BIO Digital is the world's largest virtual biotech partnering and education event, convening thousands of global biotech leaders and innovators. BioTech naturally has a special focus in times of Covid, where the rapid development of the new vaccines, among many other topics, has shown us how quickly progress can be made in this area. The pandemic has led to shifts in business focus or even changes in business models for many companies.Recent studies show that contract manufacturers for the pharmaceutical industry, CDMOs (contract development and manufacturing organizations), have so far been little involved in the production of vaccines. This is changing with the outbreak of the Covid-19 pandemic.Leading CMDOs like Aenova Group can support these challenges as a "full service provider" - from small scale manufacturing of materials for clinical trials, technical transfer to scale up of high volume production of fill and finish of biologics like Covid-19-vaccines.
<h5>Fill &amp; Finish of Vaccines</h5>
Aenova has just launched a major investment program that includes the installation of further state-of-the-art equipment for aseptic production. With a completely new "fill and finish" area for vials and prefilled syringes with high-speed filling lines including compounding at the Aenova site in Latina, Italy, more than 80 million vials and over 180 million prefilled syringes can be produced there per year. Aenova is also planning a further capacity expansion with up to three additional high-speed filling lines.
Join us virtually at BIO Digital 2021 in June and talk to our experts.
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PR Aenova Latina new injectable vials

Aenova significantly expands capacity for Fill&Finish of Vaccines and Biologics

07/05/2021 - Aenova significantly expands capacity for Fill&Finish of Vaccines and Biologics

Latina, 07/05/2021

In order to expand its fill and finish capacity for the production of Biologics and especially BSL1 and BSL2 vaccines against the SARS-CoV-2 virus, the Aenova Group is currently building a new sterile production area at its site in Latina, Italy. With an investment volume of more than 16 million euros, the focus is on a new "Fill and Finish" area for vials and prefilled syringes (PFS) with high-speed filling lines including compounding. The first line to be installed has a capacity of more than 80 million vials (glass and plastic) and over 180 million prefilled syringes per year. Aenova is also planning a phased capacity expansion of this new area with up to three additional high-speed filling lines.
As one of the world's leading contract developer and manufacturer, Aenova has many years of experience in the production of sterile injectables - from pre-filled syringes and ampoules to liquid vials, lyophilized vials and aseptic powder vials (powder filling in vials), also for biological preparations and Bio Safety Level 1 and 2 (BSL) vaccines such as mRNA, DNA, viral vectors, protein subunits, virus-like particles and inactivated vaccines. The new sterile area is based on state-of-the-art technology: the aseptic filling process is fully automated, the multi-purpose machine can process vials as well as PFS products in the preferred formats 0.5 to 10 ml for prefilled syringes and 2 ml to 10 ml for ready-to-use vials. Quality control, packaging and labeling, including serialization, complete the scope of supply. "This investment is a major step in positioning Aenova as a provider of differentiated technologies, development and high-volume manufacturing capabilities for small molecules and biologics," explains Jan Kengelbach, CEO of Aenova Group. “With this expansion in large volume vials and pre-filled syringes to complement its existing offering in ampoules, liquid and lyophilized vials, Aenova is becoming a Premier Solution Partner for sterile technologies”, says Florent Bordet, SVP Sterile &amp; Liquid Business Unit. The Aenova site in Latina, one of the largest production facilities in the Aenova Group with around 600 employees, produces and distributes pharmaceutical products for human and animal health worldwide. This new sterile offering will complement a broad site portfolio in human and animal health that includes oral solids for conventional drugs, injectables and oral solids for beta-lactam antibiotics and chewable tablets for parasiticide compounds. "We are very proud that we, as Aenova Group, will now be able to contribute greatly to the containment of the pandemic in the future," explains Paolo Abbate, Managing Director of Haupt Pharma Latina S.r.l., Member of the Aenova Group.
<figure style="float:left;width:400px;max-width:400px;margin-left:10px;margin-right:10px;"><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Filling_Aseptic_Injections_Latina.png" alt="Sterile production at Aenova, site Latina" /><figcaption>Sterile production at Aenova, site Latina: fill&amp;finish of biopharmaceuticals like COVID-vaccines. (Photo: © Marchesini Group).</figcaption></figure>

Space project in kindergarten: Little astronauts travel into space

Kirchberg, 20/04/2021

For the children of the Zuckenriet kindergarten near Kirchberg (CH), an interesting project turned into a true fantasy journey into space. Traveling in COVID-19 times: that's as good as impossible; traveling into space: even more so. But a project of the kindergarten Zuckenriet made it possible. For quite some time now, outer space, the sun, the moon and the stars have been the subject of a project in the kindergarten. The children learned about the planets of the solar system, observed the moon at home in the evening and reported the next day how it changes from night to night. Then the idea came up to make a fantastic research trip into space. Astronaut helmets were quickly made with balloons and paste, and the little astronauts could look into space from the cut-out, silver-edged peephole of the helmets. A room lined with aluminum foil became the rocket's interior. Now all that was missing were the matching "space suits. For this, the kindergarten asked Swiss Caps AG, a member of the Aenova Group. The Aenova Group is a leading global contract manufacturer for the pharmaceutical and healthcare industries. At the Kirchberg site, soft gelatine capsules are developed and produced, such as high-dose vitamin D preparations. High standards of hygiene are set in pharmaceutical production. For this reason, employees only enter the production rooms wearing special protective suits, which have now become "space suits" in the Zuckenriet kindergarten. With this, the spaceman ambience was complete and the journey into space could begin. A great project that made learning, creativity and fun possible even in times of pandemic.
<figure style="float:left;width:876px;max-width:876px;margin-left:10px;margin-right:10px;"><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Kleine_Astronauten_20042021_hr.jpg" alt="Kleine Astronauten im All" /><figcaption>Little astronauts in the Zuckenriet kindergarten. The "space suits" were donated by the Swiss Caps AG, Member of the Aenova Group. (Photo: privat)</figcaption></figure>

Vaccine Filling at the Highest Level. Aenova Combines Experience and Quality with Delivery Reliability and Cost Efficiency

14/04/2021 - Vaccine Filling at the Highest Level

16.04.2021

Recent studies show that contract manufacturers for the pharmaceutical industry, so-called CDMOs (contract development and manufacturing organizations), have so far been little involved in the production of vaccines. This is changing with the outbreak of the Covid-19 pandemic.
There are two reasons for this: On the one hand, vaccine developing companies often do not have the capabilities of commercial production and, on the other hand, the current pandemic situation requires the rapid supply of very large numbers of vaccine doses worldwide, i.e. commercial production on a very large scale. Leading CMDOs like Aenova Group can support these challenges as a "full service provider" - from small scale manufacturing of materials for clinical trials, technical transfer to scale up of high volume production of fill and finish of biologics. Fill &amp; Finish of Vaccines In order to expand its capacity for the production of vaccines against the SARS-CoV-2 virus, Aenova has just launched a major investment program that includes the installation of further state-of-the-art equipment for aseptic production. The focus is on a completely new "fill and finish" area for vials and prefilled syringes (PFS) with high-speed filling lines including compounding at the Aenova site in Latina, Italy. In the future, more than 80 million vials (glass and plastic) and over 180 million prefilled syringes can be produced there per year. Aenova is also planning a further capacity expansion with up to three additional high-speed filling lines.
Read more in the current<a href="https://www.chemanager-online.com/en/news/vaccine-filling-highest-level" target="_blank" rel="noreferrer noopener"> CHEManager International 04/2021.</a>

Unquote Podcast: In conversation with... Jan Kengelbach, BC Partners

06/04/2021 - Unquote Podcast: In conversation with... Jan Kengelbach, BC Partners / Aenova

Aenova CEO and Partner Jan Kengelbach of BC Partners, was a guest on the Unquote podcast, where he spoke to Editor Greg Gille about how to drive growth at an operational level.
Listen to Jan discuss his journey as CEO of BC Partner’s portfolio company Aenova Group, outlining how his team has turned the company around through operational, commercial and organisational change.
The full episode can be found here: <a href="https://www.unquote.com/unquote/analysis/3023312/podcast-in-conversation-with-jan-kengelbach-bc-partners" target="_blank" rel="noreferrer noopener">Unquote Podcast with Jan Kengelbach</a>

PR Aenova Gronau Sterile Filling Optical Control WP

Capacity increase of sterile production to 100 million ampoules and vials at Aenova's Gronau site

26/03/2021 - Capacity increase of sterile production to 100 million ampoules and vials

Gronau, 26.03.2021

<ul><li>Aenova starts up the new RABS filling line for ampoules from 1 ml to 5ml.</li><li>This is supplemented by fully automatic optical inspection and a new packaging line.</li><li>This will enable the Gronau site to produce around 100 million ampoules and vials per year. This corresponds to a capacity increase for sterile liquids of around 7%.</li></ul>
The production and filling of sterile products requires the highest level of safety and quality. Market demand for production capacity in the sterile field has also increased significantly in recent years and has been further boosted by the filling requirements of COVID19 vaccines. At its Gronau site, Aenova, a leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, has now significantly increased its ampoule capacities. With the new ampoule filling and closing line, the sixth sterile line at the Gronau site, a new fully automatic optical control line and a likewise new packaging line, a total of more than 100 million ampoules and vials can now be produced per year. Aenova's strategy is aimed at significantly expanding capacity and optimizing supply availability at several of the Group's sites.
Read more! 
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_cleaning_and_depyrogenation_ampoules_2.JPG" alt="New sterile filling line Aenova Gronau" /><figcaption>With the new sterile filling line, a total of 100 million ampoules and vials can be produced per year at Aenova in Gronau; here the cleaning and depyrogenation area. </figcaption></figure>

COVID: new aseptic filling line at Aenova in Latina (IT)

01/03/2021 - New filling line for vaccines at Aenova in Latina

With the new aseptic filling line at Aenova in Latina we link to an article in the Italian press (teaser in English see below):
<a href="https://www.ilsole24ore.com/art/vaccini-infialamento-e-produzione-ecco-aziende-che-possono-farlo-italia-AD3x2VLB" target="_blank" rel="noreferrer noopener">Vaccini, infialamento e produzione: ecco le aziende che possono farlo in Italia - Il Sole 24 ORE</a> 
Haupt Pharma of Latina is preparing the conversion of a department
"This is an investment of over 15 million euros - explains the managing director Paolo Abbate - which will allow us to fill up medicines in liquid form, starting with vaccines. On the front of the fight against Covid we will be able to inflate both vaccines with adenovirus such as that of Astrazeneca and with messenger RNA such as that of Pfizer and Moderna ". 
Haupt Pharma Latina is member of the Aenova Group.

„360-Grad-Service und “One Stop Shop”-CDMO“, CHEManager 02/2021

"360 Degree Service and One Stop Shop-CDMO", interview with Aenova CEO Jan Kengelbach, from: CHEManager 02/2021 (in german language)

24/02/2021 - Interview with Aenova CEO Jan Kengelbach "360° Service & One Stop Shop-CDMO"

As a Contract Development and Manufacturing Organization in the pharmaceutical sector, Aenova plays a central role in the production and development of innovative drugs. In an interview with CHEManager, Aenova CEO Jan Kengelbach presents the company's orientation as an end-to-end CDMO and reports on the "largest investment program in Aenova's history".
Kengelbach: "Aenova, as a leading contract manufacturer for numerous large pharmaceutical companies, must always ensure the supply of patients worldwide with sometimes vital medicines. The challenges of the pandemic in times of globalized commodity flows and supply chains are that, on the one hand, the active ingredients can either only be procured in Asia or - if they are produced in Europe - the precursors are often of Asian origin. In addition, in the highly regulated pharmaceutical market, only one source of raw materials is approved in many marketing authorizations, which further exacerbates the situation. However, our global procurement has so far coped very well with this stress test and ensured supply very well with proactive risk management and permanent communication with all stakeholders. 
 
Read more (in German):
<a href="https://www.chemanager-online.com/news/360-grad-service-und-one-stop-shop-cdmo" target="_blank" rel="noreferrer noopener">„360-Grad-Service und “One Stop Shop”-CDMO“, from: CHEManager 02/2021</a>
Find the .pdf here:

PM Aenova RGB New Press EN vf HP

Aenova increases capacity for tablet production in the area of highly potent, hormone-containing active ingredients

02/02/2021 - Aenova increases capacity at Regensburg site to almost 1m. tablets per hour

Regensburg, 02.02.2021

Aenova expands production of highly potent oncology drugs (up to OEB 5) with new tablet press. The fully automatic, online and process integrated control significantly increases process efficiency and enhances safety and product quality. This will enable the output of tablets for cytostatics, immunosuppressants and hormone-containing preparations at the Regensburg site to be increased to almost 1 million tablets per hour.

"Stress Test for The Supply Chain“, from: CHEManager International 04/2020

"Stress Test for The Supply Chain“. Aenova technical article in CHEManager International

Aenova Group Vice President Global Procurement sketches the supply chain challenges and risk management approaches in times of a pandemic.
<a href="https://www.chemanager-online.com/en/news/stress-test-supply-chain" target="_blank" rel="noreferrer noopener">„Stress Test for The Supply Chain“ – from: CHEManager International 4/2020</a>
Find the .pdf here:
<a href="https://www.aenova-group.com/content/Stress_Test_Supply_Chain_CHEManager_Int_04-2020_Aenova.pdf" target="_blank" rel="noreferrer noopener">"Stress Test for the Supply Chain" from: CHEManager International 04/2020</a>

PM Aenova SVP Sales Marketing EN

New Senior Vic﻿e President Sales & Marketing at Aenova Group

24/11/2020 - New Senior Vic﻿e President Sales & Marketing at Aenova Group

Starnberg, 24.11.2020

<h2> </h2>
Dr. Mike Schaefers joins the Aenova Group as new Senior Vice President Sales &amp; Marketing: "For us, it's about our patients and customers. Reliability and a continuous focus on quality are of high importance." 

Effective November 23, 2020 the Aenova Group has appointed Dr. Mike Schaefers as the new SVP Sales and Marketing. The sales and marketing strategist will expand the global business for contract development and production

PM Aenova New Vegagels EN 1

Product launch of vegan soft capsules: the new Aenova VegaGels®

16/11/2020 - Product launch vegan soft capsules: the new Aenova VegaGels®

Cornu, 16.11.2020

Aenova presents the new generation of its vegan soft capsules. The new VegaGels® are produced on a vegetable basis using new technology. The composition of the new soft capsules conforms to US, EU and Chinese regulatory specifications. The new VegaGels® are available in many different sizes, shapes and colors.

Power from solar energy

Power from solar energy: Aenova produces pharmaceuticals more sustainably

27/10/2020 - Power from solar energy: Aenova produces pharmaceuticals more sustainably

Cornu, 27.10.2020

At SWISSCAPS Romania, member of the Aenova Group, the new photovoltaic system was put into operation. With an output of around 360 MWp, the photovoltaic plant contributes to a climate-friendly power supply. The new PV system is a sub-project of the company's sustainability strategy.

Aenova Customer Letter 102020

COVID-19 Update October 2020

As we navigate through an unprecedented global crisis, we want to update you on what Aenova Group is doing to address the COVID-19 pandemic.

PR Aenova Tittmoning EN 0

Aenova expands production capacities at the Tittmoning site

13/10/2020 - Aenova expands production capacities at the Tittmoning site

Tittmoning, 13.10.2020

On the company site of Dragenopharm Apotheker Püschl GmbH, member of the Aenova Group, a new production building is under construction. The production capacity of the site can thus be increased to over 10 billion tablets per year. 
The investment of about € 25 million lays the cornerstone for more than 100 new jobs and is part of further investment projects of the Aenova Group.

Facing Strong Headwinds. Statement Aenova Group in CHEManager International

Facing Strong Headwinds. Statement of the CEO Aenova Group in CHEManager International

CHEManager International presents a survey of the pharmaceutical industry, including CDMOs, on what they believe are the key lessons learned from working under pandemic conditions to date and how the current pharma business model will change in the post-Covid era. Jan Kengelbach, CEO Aenova Group, summarizes three key points. Read more: “<a href="https://www.chemanager-online.com/en/news/facing-strong-headwinds" target="_blank" rel="noreferrer noopener">Facing Strong Headwinds</a>” – published in CHEManager International

Active environmental protection with renewable energies at the Aenova site in Cornu

Cornu, 10.09.2020

More sustainable production thanks to new photovoltaic system Active environmental protection with renewable energies: the SwissCaps Romania plant of Aenova Group in Cornu, specialist mainly in the production and packaging of soft gel capsules with vegan or gelatin shells, will produce around 425 MwH per year with the new photovoltaic system on the site's roof. <a href="https://bit.ly/2F7ywaw" target="_blank" rel="noreferrer noopener">https://bit.ly/2F7ywaw</a> (Video from ENGIE Romania in Romanian)

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