AGC Biologics to increase capacity for pDNA and mRNA manufacturing in Heidelberg

The expansion plans include an additional manufacturing line, a new cleanroom and a new process development lab

Global biopharmaceutical CDMO AGC Biologics has laid out plans to expand its Heidelberg facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects.

By adding an additional GMP manufacturing line, the company will boost its current 100-L and 1,000-L manufacturing capacities for a variety of different biologics projects.

The expansion includes a new GMP cleanroom for mRNA development and manufacturing, a new process development lab for microbial protein and cell and gene therapy projects, and additional warehouse capacity.

The expanded capabilities will also allow the CDMO to meet the increasing demands of the rapidly growing cell and gene therapy market.

This announcement is the latest in a series of investments AGC Biologics has made this year to expand its offerings and global footprint:

Last month, the company broke ground on a new multipurpose facility in Copenhagen, Denmark that will grow AGC Biologics’ global capacity.

Approximately one month ago, the company acquired the previously owned Novartis Gene Therapies' Longmont, CO facility, helping it to expand its cell and gene therapy capabilities footprint into the US.

Earlier this year, the company expanded its C> facility in Milan, Italy as well, adding additional capacity and viral vector suspension capabilities.

In a statement, AGC Biologics said it anticipates the Heidelberg facility's new capabilities will be fully operational in 2023.

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a commitment to deliver the highest standard of service to our clients. Our network of cGMP facilities spans three continents. We offer deep industry expertise, innovative solutions and technologies, and customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial, for mammalian and microbial. We never lose sight of our pledge to deliver reliable and compliant drug substance supply, on time.