The expanded facilities will also allow the contract development and manufacturing organization (CDMO) to meet the increasing demands of the rapidly growing cell and gene therapy (CGT) market.
The outlay involved was not disclosed.
AGC Biologics, which is headquartered in Seattle, Washington State, operates multiple manufacturing lines and a variety of scales at the Heidelberg, Germany facility.
The investment will increase the organization's current 100L and 1,000L manufacturing capacities for a variety of different biologics projects through the addition of a GMP manufacturing line; the project will also result in a new GMP cleanroom for mRNA development and manufacturing.
“The expansion will provide additional space that will be used to build a new small-scale production line for pDNA and mRNA, further enhancing our small scale lines. The new capacity allows us to support small scale production of 10L and 50L for pDNA and [initiate] new projects for mRNA development,” a spokesperson for the CDMO told us.
mRNA, now well known for its use in COVID-19 jabs, is a drug modality that is being developed by various therapeutic developers, for which demand is expected to increase globally in relation to its use in both vaccines and other applications.
AGC Biologics said it can leverage its technology and experience, especially the existing established commercial pDNA capabilities at the Heidelberg site, to support its entry into the mRNA space.
The expansion will also see a new process development lab for microbial protein and CGT projects come on stream, and additional warehouse capacity.
The facility's new capabilities are set to be fully operational by 2023.
Investment program
The Heidelberg project is the latest in a series of investments AGC Biologics has made this year.
It follows the CDMO’s acquisition of a Longmont, Colarado facility from Novartis Gene Therapies, helping AGC Biologics expand its CGT capabilities footprint into the US. Earlier this year, the company expanded its CGT facility in Milan, Italy as well, adding additional capacity and viral vector suspension capabilities.
More recently, the company broke ground on a new multipurpose facility in Copenhagen, Denmark.