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New sterile production area at Italy facility aims to benefit biologics manufacturing, such as BSL vaccines
In an effort to further develop its fill-and-finish capacity for the production of biologics—especially BSL1 and BSL2 vaccines against the SARS-CoV-2 virus—the Aenova Group is in the process building a new sterile production area at its site in Latina, Italy. With an investment volume of more than $19 million, the company's priority is on a new fill-and-finish section 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 also plans to have a phased capacity expansion of the new area, with up to three additional high-speed filling lines.
The contract development and manufacturing organization (CDMO) has extensive experience in producing sterile injectables, from pre-filled syringes and ampoules to liquid vials, lyophilized vials and aseptic powder vials (powder filling in vials), along with 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 aseptic filling process is fully automated, as the machine can process vials as well as PFS products in the preferred formats of 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.