- A new area for sterile production including vaccine fill&finish is being built at the Aenova site in Latina, Italy, for approximately 16 million euros and will be commercial ready in October 2021.
- The first line to be installed will be capable of delivering up to 80 million vials (glass and plastic) or 180 million pre-filled syringes per year.
- Further expansions going up to 4 High Speed lines are already planned.
Latina, 7. May 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 & 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.
Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industries for human and animal health. Our services include end-to-end manufacturing and development of all dosage forms and potencies (from nutraceuticals to high potent APIs) at 15 sites in Europe and the USA. With our comprehensive know-how, many years of experience, innovative technologies and highest quality standards, we are a reliable, long-term partner for pharmaceutical and consumer health care customers worldwide. Around 4,500 well-trained employees contribute to the success of the Group.
- Contact for inquiries:Dr. Susanne Knabe
Head of Communication & PR
Aenova Holding GmbH
Berger Straße 8-10
Mobile: +49 170 22 368 42