AGC Biologics expands the single-use bioreactor capacity at its Denmark site

AGC Biologics has finished an expansion at its site in Copenhagen, Denmark. This makes its bioreactors twice as big for mammals cell growth

AGC Biologics said that a new production building would be finished at its campus in Copenhagen, Denmark, in early June 2024. The increase doubles the site's single-use bioreactor capacity for services based on mammals and lets the company make 150 more batches of drugs every year.

A press release from June 4, 2024 says that the finished project adds 19,000 m2 of space, which includes a large manufacturing floor, more space for quality control and process development labs, utilities to support all operations and keep power from going out during natural disasters, and a fully dedicated warehouse.

The company first talked about this growth plan in November 2020, and it will spend about $200 million on it. A Phase II/III commercial product is already being made in the new building.

In a company press release, Christoph Winterhalter, chief business officer of AGC Biologics, said, "The AGC Biologics Copenhagen site is still one of the busiest in our network and has all the necessary commercial approvals from the FDA, EMA, HCA, PMDA, ANVISA, and others. We are more than happy to offer the capacity and capabilities that our current and future customers will look for." "The growth and our new drug product alliance show that AGC Biologics is flexible enough to meet all of developers' needs, from pre-clinical to commercial."

The manufacturing expansion includes eight 2000-L single-use bioreactors with two seed trains and two separate downstream suites. The Copenhagen site is now one of only a few in the world that has multiple single-use bioreactor systems of this size and can produce high-level clinical and commercial batches. The site has several single-use suites for developers who need to tech-transfer in an existing process for products coming into the facility. This gives the site the freedom to do like-for-like process and knowledge activities, according to the press release.
The news of this finished expansion comes after AGC Biologics formed an end-to-end protein biologics drug product relationship with BioConnection in May 2024. The goal of the relationship with BioConnection is to provide "gene-to-vial" services, such as developing drug substances, making them, and aseptically filling and finishing them.

"I am so proud of everyone at our site for their hard work and ability to work together over the last few years. It is truly amazing what we can do when we all work together." "We're excited to offer more of the important features that the industry wants to help patients in need," said Andrea C. Porchia, general manager of AGC Biologics Copenhagen, in a press release.

Source: AGC Biologics