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, 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 a global contract development and manufacturing organization (CDMO), 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,” said Jan Kengelbach, CEO of Aenova Group.
 
Florent Bordet, senior vice president of Aenova’s sterile and liquid business unit, said, “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.”
 
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,” said Paolo Abbate, managing director of Haupt Pharma Latina S.r.l., Member of the Aenova Group.