AGC Bio bolsters pDNA and mRNA capacity with German plant expansion

CDMO AGC Bio will expand its Heidelberg, Germany facility to increase its manufacturing capacities for customer pDNA and mRNA projects.

The expansion, of which financial details have not been disclosed, sees contract development manufacturing organization (CDMO) AGC Biologics boost its current production capacity for plasmid-DNA (pDNA) and messenger RNA (mRNA) by adding an additional manufacturing line.

The Heidelberg expansion will also include additional warehouse capacity, a cleanroom for mRNA development and production, and a process development lab for microbial protein and cell and gene therapy projects.

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“Cell and gene therapy products have brought new promising treatments in multiple areas of high unmet medical needs. However, a record-breaking cell and gene therapy pipeline is creating vast market opportunities yet causing a manufacturing capacity shortage,” a spokesperson for AGC told BioProcess Insider.

“Creating new manufacturing capacity requires investments, lead time, and technical expertise. [The expansion] puts AGC Biologics in a unique position as one of the few CDMOs in the world that can provide end-to-end services for the development and manufacturing of cell and gene therapies.”

The Alliance for Regenerative Medicine reported that this year there are currently 1,320 industry-sponsored regenerative medicines and advanced therapies trials ongoing globally.

According to AGC Bio, the expansion also builds on the firm’s decision to buy a 622,000 square-foot cell and gene therapy facility in Longmont – north of Denver, Colorado from Novartis in July.

A year prior to this, AGC Bio acquired a cell and gene therapy site in Milan, Italy, added through the €240 million ($284 million) acquisition of Molecular Medicine (Molmed).

The facility’s added capabilities are expected to be fully operational in 2023 and the CDMO said it “will continue to invest in our Heidelberg facility and new jobs will be created as a result of this latest expansion.”