AGC Biologics Doubles Mammalian Manufacturing Capacity with New Copenhagen Facility

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has officially begun operations at its newly constructed manufacturing facility in Copenhagen, Denmark. The company received authorization and licensing from the Danish Medicines Agency in September, marking the successful completion of a three-year expansion project that has effectively doubled the site's capacity for mammalian-based biopharmaceutical production.

The new four-story, 19,000 square meter building represents a significant leap forward in AGC Biologics' manufacturing capabilities. Equipped with cutting-edge mammalian systems and single-use technology, the facility boasts a production line featuring eight 2,000-liter bioreactors, two downstream processing suites, and dedicated spaces for warehousing and quality control. This expansion not only enhances the company's production capacity but also reinforces its position as a key player in the European CDMO market.

Andrea Porchia, General Manager of the Copenhagen site, emphasized the milestone's importance, stating, "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." The facility has already commenced production on its first project, a phase II/III clinical trial, showcasing its immediate impact on the biopharmaceutical development landscape.

This expansion is particularly significant given the growing demand for biologics manufacturing capacity worldwide. As the pharmaceutical industry increasingly focuses on complex biological therapies, including monoclonal antibodies, recombinant proteins, and advanced cell and gene therapies, the need for sophisticated manufacturing facilities has surged. AGC Biologics' investment in this state-of-the-art facility positions the company to meet this rising demand and support the development of novel treatments for a wide range of diseases.

The Copenhagen site's enhanced capabilities complement AGC Biologics' existing expertise in both mammalian and microbial systems, from early-stage development through clinical and commercial manufacturing. With seven commercial products already under its belt, the expanded facility is poised to play a crucial role in bringing new biologics to market more efficiently.

This development also underscores the strategic importance of Europe in the global biopharmaceutical manufacturing landscape. By significantly expanding its presence in Copenhagen, AGC Biologics strengthens its ability to serve clients across Europe and beyond, potentially accelerating the development and commercialization of new biological therapies for patients worldwide.

The successful launch of this facility reflects AGC Biologics' commitment to innovation and its responsiveness to the evolving needs of the biopharmaceutical industry. As the company continues to expand its global footprint, with facilities across the U.S., Europe, and Asia, this new Copenhagen site represents a critical piece in its strategy to provide comprehensive, end-to-end CDMO services to clients around the world.

For the biopharmaceutical industry, this expansion signifies increased access to high-quality manufacturing capabilities, potentially leading to faster development timelines and more efficient production of life-saving therapies. As AGC Biologics leverages its enhanced capacity and technological capabilities, it is poised to play an even more significant role in shaping the future of biopharmaceutical manufacturing and drug development.