The expansion addresses sustained demand particularly for fill-finish services to produce COVID-19 vaccines, says CDMO Aenova Group.
German contract development manufacturing organization (CDMO) Aenova has invested more than $19 million to build a sterile production site at its 40,000 square-foot facility in Latina, Italy.
The expansion will focus predominately on a fill-finish area for prefilled syringes (PFS) with high-speed filling lines and vials. The first high-speed line to be fitted has a capacity of more than 80 million vials and over 180 million PFS annually.
According to the firm, it is also planning a phased capacity expansion, which will see it add up to three more high-speed filling lines.
‚ÄúThe 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.‚ÄĚ said Jan Kengelbach, CEO of Aenova.
She continued: “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.‚ÄĚ
While the expansion of its fill-finish capacity is for the production of biologics, Aenova stressed it is especially for COVID-19 vaccines.
“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, member of the Aenova Group.
COVID capacity catalyst
Both CDMOs and end users have upped their capacity in fill-finish and other areas to respond to COVID-19 and to prepare for potential pandemic threats.
CDMO Catalent added a high-speed filling line in March at its site in Anagni, Italy to increase its manufacturing capacity for Johnson & Johnson‚Äôs single-shot COVID-19 vaccine. The firm also dedicated a filling line to Moderna for its mRNA COVID-19 jab at its Bloomington, Indiana plant.
MilliporeSigma accelerated its plans in March to invest $30 million in its French site in Molsehim, adding a 18,300 square-foot single-use assembly production unit on the back of COVID-19 demand.
This week, BioNTech agreed terms for a 50/50 Joint Venture (JV) with Fosun Pharma to manufacture its COVID-19 vaccine BNT162b2 in mainland China. The manufacturing facility could produce one billion doses of the vaccine each year.