AGC Biologics Begins Operations at New State-of-the-Art Manufacturing Building in Copenhagen after Successful Inspection and Licensing from Danish Medicines Agency
Copenhagen, Denmark
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October 10, 2024 12:07 AM Mountain Daylight Time
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today the successful completion of the final milestone at its new manufacturing building at its 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 its 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. It operates and supports drug substance projects using both mammalian and microbial systems and has 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.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.
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