Aenova invests in aseptic fill/finish facility for vaccines and biologics

ITALY – Aenova has announced a significant increase in cutting-edge aseptic production area at Latina, Italy, facility featuring a completely new high-speed flexible line for vials and prefilled syringes (PFS), as well as a completely new compounding area.

This area has the capacity to store more than 80 million vials and 180 million prefilled syringes for vaccines and biologics. Additional capacity expansions to a total of four high-speed filling lines are also planned.

Aenova has many years of experience as a global contract development and manufacturing organization (CDMO) in the production of sterile injectables.

Its unrivalled specialty ranges from pre-filled syringes and ampoules to liquid vials, lyophilized vials, and aseptic powder vials (powder filling in vials), as well as biological preparations and Bio Safety Level 1 and 2 (BSL) vaccines such as mRNA, DNA, viral vectors, protein subunits

This first high-speed flexible line can handle both vials and PFS products in the preferred sizes of 0.5 to 10 ml for prefilled syringes and 2 to 10 ml for ready-to-use vials.

The scope of supply is completed by quality control, packaging, and labeling, including serialization.

“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 and liquid business unit.

With around 600 employees, the Aenova site in Latina is one of the Aenova Group’s largest production sites, producing and distributing pharmaceutical products worldwide.

The facility’s various buildings allow it to be in the market with a diverse site portfolio that 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,” said Paolo Abbate, managing director of Haupt Pharma Latina.

Jan Kengelbach, CEO of Aenova Group, said, “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. 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.”