AGC Biologics Completes Denmark Expansion to Double Single-Use Bioreactor Capacity

Editor's note: this story was originally published on BioPharmInternational.com.

With the completion of a new manufacturing building at its Copenhagen, Denmark, campus, AGC Biologics doubles its single-use bioreactor capacity for mammalian-based services at the site, the company announced in early June 2024. The increased capacity allows the company to produce an additional 150 batches of drug product per year.

The completed project adds 19,000 m² of space, including a large manufacturing floor, expanded quality control and process development lab space, utilities for supporting all operations and preventing outages caused by natural disasters, and a fully dedicated warehouse, according to a June 4, 2024 press release.

The company first announced this planned expansion project in November 2020, into which it is investing approximately $200 million (1). Production in the new building has already begun with a Phase II/III clinical product.

“AGC Biologics Copenhagen site continues to be one of the most active in our network with all the necessary commercial approvals—FDA, EMA [European Medicines Agency], HCA, PMDA [Pharmaceuticals and Medical Devices Agency], ANVISA [Brazilian Health Regulatory Agency], 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, chief business officer, AGC Biologics, in the company press release. “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.”

The manufacturing expansion comprises eight 2000-L single-use bioreactors with two seed trains and two independent downstream suites, making the Copenhagen site one of the few sites globally that houses multiple single-use bioreactor systems at this magnitude and that is capable of high-level production of clinical and commercial batches. For developers that need to tech-transfer in an existing process for products entering the facility, the site also houses multiple single-use suites to offer that flexibility, allowing the site to perform like-for-like process and knowledge activities, according to the press release.

The announcement of this completed expansion follows on the heels of AGC Biologics’ earlier end-to-end protein biologics drug product partnership with BioConnection in May 2024 (2). The partnership with BioConnection aims to offer “gene-to-vial” services, including drug substance development, manufacturing, and aseptic fill/finish capabilities for drug products.

“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, in the press release.

References

1. AGC Biologics. AGC Biologics to Expand Biopharmaceutical CDMO Capacity. Press Release, Nov. 30, 2020.
2. AGC Biologics. AGC Biologics and BioConnection Partner to Offer New End-to-End Biopharmaceutical Drug Substance and Drug Product Development and Manufacturing Offering. Press Release, May 22, 2024.

Source: AGC Biologics