AGC Biologics has completed a new manufacturing building at its Copenhagen campus. The expansion doubles the site’s single-use bioreactor capacity for mammalian services, allowing it to produce 150 more batches of drug product each year.

The expansion adds 19,000 square meters of space in an ultramodern building that houses a large manufacturing floor, expanded quality control and process development lab space, utilities to support all operations and prevent outages caused by natural disasters, and a fully dedicated warehouse to serve the entire AGC Biologics Copenhagen campus.

The new AGC Biologics Copenhagen manufacturing building is already in production with its first customer, a phase II/III clinical product. AGC Biologics announced the planned expansion in November 2020, investing roughly $200 million into the work.

One-of-a-kind single-use manufacturing offering

The new manufacturing area offers 8 x 2,000 L single-use bioreactors with two seed trains, as well as two independent downstream suites—more than doubling the existing capacity offered at this site for mammalian-based projects.

According to the company, it is now one of the few sites in the world with multiple single-use bioreactor systems of this magnitude capable of producing batches at high levels of clinical and commercial production. Further, for developers needing to transfer in an existing process, AGC Biologics Copenhagen’s multiple single-use suites give the site greater flexibility to take on technical transfers and perform like-for-like process and knowledge activities for products entering the facility, eliminating lag time associated with onboarding a new CDMO.

The news comes after AGC unveiled an end-to-end protein biologics drug product partnership with Dutch-based BioConnection in late May. The alliance provides a secure and full-service “gene-to-vial” offering for biopharma developers with drug substance development, manufacturing and aseptic fill and finish capabilities for drug products.

“AGC Biologics Copenhagen site continues to be one of the most active in our network with all the necessary commercial approvals—FDA, EMA, HCA, PMDA, ANVISA etc.—and we are more than happy to offer the capacity and capabilities our current and future customers will look for with this completed expansion,” said Christoph Winterhalter, CBO, AGC Biologics. “The expansion, combined with our new drug product alliance, demonstrates AGC Biologics’ agility to meet all the needs developers may have, from pre-clinical through commercial.”

AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems and has a gold EcoVadis Sustainability Rating for its environmental, health and sustainability practices.

“I am extremely proud of the work and collaboration of everyone at our site over the last several years, it is truly remarkable to see what we can accomplish by working together. We are eager to offer more of the important capabilities the industry is looking for to support patients in need,” said Andrea C. Porchia, general manager, AGC Biologics Copenhagen.