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AGC Biologics to Prepare Late Phase and Commercial Runs for Immunocore
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new late-stage clinical and process performance qualification (PPQ) project at its Heidelberg, Germany site with Immunocore Holdings Plc (Nasdaq: IMCR). Immunocore intends to use the Heidelberg site to complete late-stage manufacturing and prepare for commercialization for IMC-F106C, Immunocores PRAME-targeted bispecific therapy.
Under the agreement, AGC Biologics will leverage its microbial fermentation and manufacturing experience to perform bench-scale qualification and process characterization, and other required studies to support phase III manufacturing, as well as PPQ runs. Pending a successful PPQ campaign and regulatory approvals, the Immunocore project is expected to move into commercial stages at the AGC Biologics Heidelberg site.
This is the next step in the partnership for this candidate between the two companies, with AGC Biologics providing early-phase support for this same project. Immunocore and AGC Biologics previously worked together on commercial manufacturing readiness for KIMMTRAK (tebentafusp-tebn) at the CDMOs Copenhagen site.
This is a great example of the power of the AGC Biologics network and our ability to collaborate at our global sites to support important client projects, said Dieter Kramer, General Manager, AGC Biologics Heidelberg. I am extremely proud of our team here in Heidelberg and the work theyve done to support this project. We are pleased Immunocore has agreed to work with us on these next important steps in their products lifecycle, as our team has the late-stage and commercial expertise to deliver what is needed.
AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The AGC Biologics Heidelberg site has produced biologics products for 40 years and has built a track record for navigating clients through the early clinical phases and into later stages to help prepare for commercial production. In addition to fermentation, the site serves as a center of excellence for plasmid DNA (pDNA) and messenger RNA (mRNA).
To learn more about AGC Biologics microbial system-based biologics, plasmid DNA (pDNA) and messenger RNA (mRNA) manufacturing site in Heidelberg, visit www.agcbio.com/facilities/heidelberg. For more information on the companys Protein Biologics, pDNA, Cell Therapy, Viral Vector and mRNA drug product services go to www.agcbio.com.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
View source version on newsdirect.com: https://newsdirect.com/news/agc-biologics-to-prepare-late-phase-and-commercial-runs-for-immunocore-237292105