December 11, 2023
Contract development manufacturing organization (CDMO) AGC Biologics will use its recently expanded Heidelberg, Germany facility to help service a bispecific collaboration with Immunocore.
Under the agreement, AGC Biologics will perform the required studies to support Phase III manufacturing and process performance qualifications (PPQ) runs for IMC-F106C, Immunocore’s PRAME-targeted bispecific therapy. Once these are cleared, the CDMO will move production to the Heidelberg site to support commercial production.
“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 of the Heidelberg facility.
“I am extremely proud of our team here in Heidelberg and the work they’ve done to support this project. We are pleased Immunocore has agreed to work with us on these next important steps in their product’s lifecycle, as our team has the late-stage and commercial expertise to deliver what is needed.”
Immunocore and AGC Biologics already work together on commercial manufacturing readiness for KIMMTRAK (tebentafusp), Immunocore’s recently approved anti-cancer to treat uveal melanoma, from the CDMO’s Copenhagen site.
With the Heidelberg site completed, AGC Biologics has added plasmid DNA (pDNA) capabilities and says it can produce different projects simultaneously while reducing timelines. An added line includes optimized personnel and material flow, chromatography, laminar flow, single-use bioreactor technology, clean rooms for fermentation, and warehouse space.
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