- AGC Biologics has completed a new manufacturing building at its Copenhagen campus, doubling the site’s single-use bioreactor capacity for mammalian services.
- The company announced the planned expansion in November 2020, investing roughly $200 million into the work.
AGC Biologics has completed a new manufacturing building at its Copenhagen campus. This expansion doubles the site’s single-use bioreactor capacity for mammalian services, enabling it to produce 150 more batches of drug product each year.
The expansion adds 19,000 square meters of space in a modern 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. The company announced the planned expansion in November 2020, investing roughly $200 million into the work.
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.
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.
Christoph Winterhalter, CBO, AGC Biologics, said, “The 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.”
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.
Andrea C. Porchia, general manager, AGC Biologics Copenhagen, said, “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.”
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