Global CDMO’s Heidelberg site to support Process Performance Qualification for IMC-F106C late-stage program and prepare for commercial readiness.
Today, we announced a new late-stage clinical and process performance qualification (PPQ) project at our 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, Immunocore’s PRAME-targeted bispecific therapy.
Under the agreement, AGC Biologics will leverage our 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.
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