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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PR Aenova Probiotic softgel capsules

Kirchberg

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

Latina

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

Cornu

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

Bad Aibling

"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.

Tittmoning

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.
<a href="https://www.aenova-group.com/en/contact" style="margin:0px;padding:0px;border:0px;font:inherit;vertical-align:baseline;text-decoration:none;color:rgb(51,151,255);">Get in touch with us!</a> For more information, visit the <a href="https://www.bio.org/events/bio-digital" target="_blank" style="margin:0px;padding:0px;border:0px;font:inherit;vertical-align:baseline;text-decoration:none;color:rgb(51,151,255);" rel="noreferrer noopener">BIO Digital</a> website.

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

Gronau

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

Regensburg

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

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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)

New Head of Global Operational Excellence at Aenova Group

David Hitchcock is the new Head of Global Operational Excellence at Aenova Group: 
"I look forward to working with the teams at our sites to drive performance and further develop the culture of continuous improvement with our Aenova Manufacturing System."

Haupt Pharma Wülfing modernizes the building for pharmaceutical development

Gronau, 03.08.2020

In pharmaceutical development and production, quality and safety are the central issues. This naturally also applies to buildings and their infrastructure. Haupt Pharma Wülfing GmbH, a member of the Aenova Group with over 4,300 employees worldwide and around 450 employees in Gronau, has now put the modernized development building back into operation.

New VP Commercial Excellence at Aenova Group

23.07.2020

Dr. Volker Viktor is the new Vice President Commercial Excellence at Aenova Group: 
"In everything we do, we always focus on the value we can achieve for our customers!"

New Head of Business Development & Strategy at Aenova Group

15.07.2020

Dr. Matthias Groh is the new Head of Business Development &amp; Strategy at Aenova Group: 
"With its broad technological offering and international presence, Aenova Group is particularly well positioned to deliver accessible and innovative medicines worldwide."

PM Aenova New Organizational Structure vf

Aenova presents new organizational structure of the group

Starnberg, 09.07.2020

Aenova Group now announces the company's new organizational structure: with the three new business units Solids, Semi Solids &amp; Liquids and Softgel Capsules, the company's 15 manufacturing sites will be organized to focus on high-growth business areas.

Wolfratshausen

New Managing Director Site Wolfratshausen

Wolfratshausen, 08.06.2020

Dr. Franz Clementschitsch is the new Managing Director at the Wolfratshausen site: "I look forward to working with my team to drive quality, delivery reliability, service excellence and continuous improvement and to continue creating value for our customers."

New Managing Director Site Bad Aibling

Bad Aibling, 05.06.2020

Thomas Lemke is the new Managing Director at the Bad Aibling site: "Quality, delivery reliability, service excellence and continuous improvement are important parameters - that is what we strive for at Aenova".

Sisseln

New Managing Director Site Sisseln

Sisseln, 04.06.2020

Fridrik Thorsteinsson is the new Managing Director at the Sisseln site: 
"We are proud to produce 100% CO2-neutral and to offer cost-efficient quality solutions to our Aenova customers as a highly reliable partner."

In COVID-19 times: Haupt Pharma Amareg produces disinfectant for
the city of Regensburg

In COVID-19 times: Haupt Pharma Amareg produces disinfectant for the city of Regensburg

Regensburg, 03.06.2020

Haupt Pharma Amareg GmbH, a member of the Aenova Group, has been supporting the city of Regensburg with disinfectants since the beginning of the Corona crisis. Since March 2020, 12,000 liters have already been delivered.

COVID-19: Start of Phase 2 clinical trial of IMU-838

Immunic Therapeutics has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to initiate a Phase 2 clinical trial with its selective oral DHODH inhibitor IMU-838 for the treatment of COVID-19. We at Aenova Group are pleased to have been able to participate in the development of the drug and to supply the material for the clinical trial.

New Vice President Corporate HSES at Aenova Group

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Dr Pedro Diaz Kraus is the new Vice President Corporate HSES at Aenova Group: „At Aenova we care for our customers and our employees in matters of Health and Safety as well as maintaining high Environmental and Sustainability standards for our products, processes and plants.”

New Head of Development Services at Aenova Group

Dr. Jörg Gampfer is the new head of development services at Aenova Group: „We offer a high level of quality and efficiency throughout all the stages of product development and manufacturing – that´s the Aenova approach.”

CMO Leadership Award: Aenova wins awards in 3 categories

Prestigious Life Science Leader's CMO Leadership Award recognizes leaders in pharmaceutical contract manufacturing.

Aenova Group successfully completes refinancing

Aenova Group, one of the world's largest Contract and Development Manufacturing Organizations (CDMO) for the pharmaceutical industry, announced today that it has successfully completed the refinancing of its financial structure.