Today, we announced the successful completion of the final milestone at our new manufacturing building at our Copenhagen site. The site received authorization and a license to begin production from the Danish Medicines Agency for its new four-story 19,000 m² manufacturing building in September, allowing it to begin official operations.
AGC Biologics started production on our first project at the new building shortly after approval, a phase II/III clinical project. The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors, two complementary downstream suites, and dedicated warehouse and quality control laboratory spaces. The new building has doubled the capacity for mammalian manufacturing at the AGC Biologics Copenhagen manufacturing plant.
“Getting operational approval from the Danish Medicines Agency was the final step in a three-year journey that many individuals have contributed to, and this milestone is one we were proud to celebrate as a site” said Andrea Porchia, General Manager of the Copenhagen site. “We now begin the work of producing more treatments at this facility than ever before and believe this is one of the best locations for developer partners seeking CDMO services in Europe.”
AGC Biologics Copenhagen has an extensive operational track record and expertise spanning early-stage development through clinical and commercial manufacturing. We operate and support drug substance projects using both mammalian and microbial systems and have produced seven commercial products.
To learn more about AGC Biologics’ protein biologics manufacturing site in Copenhagen, visit https://www.agcbio.com/facilities/copenhagen. For more information on the company’s end-to-end global CDMO services in the U.S., Europe, and Japan, visit www.agcbio.com.
