AGC Biologics to Prepare Late-Phase and Commercial Runs for Immunocore

AGC Biologics unveiled a new late-stage clinical and process performance qualification (PPQ) project at its Heidelberg, Germany site with Immunocore Holdings Plc. 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 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. 

In a statement, the company said that 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 CDMO’s 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 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.”