AGC Biologics has announced a new late-stage clinical and process performance qualification (PPQ) project at its Heidelberg, Germany site in collaboration with Immunocore Holdings Plc (Nasdaq: IMCR). The focus of the project is IMC-F106C, Immunocore’s PRAME-targeted bispecific therapy. AGC Biologics will leverage its microbial fermentation and manufacturing expertise to conduct bench-scale qualification, process characterization, and other necessary studies to support phase III manufacturing and PPQ runs. Pending successful PPQ and regulatory approvals, the Immunocore project is expected to progress to commercial stages at AGC Biologics Heidelberg site. This marks the next phase in the partnership between the two companies, with AGC Biologics previously providing early-phase support for the same project and collaborating on commercial manufacturing readiness for KIMMTRAK® at the CDMO’s Copenhagen site.
The agreement underscores the collaborative strength of the AGC Biologics network, demonstrating its ability to engage global sites in support of critical client projects. Dieter Kramer, General Manager of AGC Biologics Heidelberg, expressed pride in the team’s efforts and highlighted the company’s late-stage and commercial expertise. The Heidelberg facility, running multiple cGMP microbial fermentation lines, has been producing biologics for four decades. It has a proven track record of guiding clients through early clinical phases to later stages, preparing for commercial production. Besides fermentation, the site serves as a center of excellence for plasmid DNA (pDNA) and messenger RNA (mRNA).
AGC Biologics encourages further exploration of its microbial system-based biologics, plasmid DNA (pDNA), and messenger RNA (mRNA) manufacturing site in Heidelberg through www.agcbio.com/facilities/heidelberg. Additional information on Protein Biologics, pDNA, Cell Therapy, Viral Vector, and mRNA drug product services can be found at www.agcbio.com. This partnership showcases the company’s commitment to advancing innovative therapies and its capabilities in supporting clients through various stages of drug development.
About AGC Biologics
AGC Biologics is a global CDMO based in Seattle, Washington, USA. The company provides pharmaceutical development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, AGC Biologics has the resources and the available capacity you need to accelerate your race to GMP. From development to clinical trials, to full-scale commercialization, AGC Biologics can help to reach goals at any stage in the drug development and manufacturing process.
AGC Biologics specialize in the following modalities and substances, mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA (pDNA), Messenger RNA (mRNA), viral vectors, and genetically engineered cells. AGC Biologics services range from Process Development, Analytical Development, cGMP Manufacturing, Quality Control and Quality Assurance, and Process Validation.