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

  • The new sterile area at the Aenova site in Latina, Italy, goes into commercial production end of October 2021.
  • This first phase of an around 16 million euros investment includes a high-speed flexible line for injectables.
  • The annual capacity is up to 80 million vials (including biologics and vaccines up to BSL-2) and 180 million prefilled syringes.

Extensions up to 4 high-speed lines are being planned.

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 & 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 allow being in the market with a broad site portfolio which includes injectable and oral solids for conventional medicines, injectable and oral solids. “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.

Sterile production at Aenova, site Latina: fill&finish of biopharmaceuticals like COVID-vaccines. (Photo: Aenova).

About Aenova Group

The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industries. As a one-stop-shop, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes of pharmaceuticals and dietary supplements for human and animal health: solid, semi-solid and liquid, sterile and non-sterile, high and low dose, OEB 1-5. With around 4,300 employees at 16 sites in Europe and the U.S., Aenova generates annual sales of around €740 million.

Press Contact:

Dr. Susanne Knabe
Head of Corporate Communications & PR

Aenova Holding GmbH

Berger Straße 8-10

D-82319 Starnberg

Mobile: +49 170 22 368 42