Aenova has unveiled a significant expansion of 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 serialization, 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 and 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, 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,” said Paolo Abbate, managing director of Haupt Pharma Latina S.r.l., a member of the Aenova Group.
 
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.”
 
Sterile production at Aenova, site Latina: fill&finish of biopharmaceuticals like COVID-vaccines. (Photo: Aenova)