Cell Therapy Manufacturing Challenges and cGMP-Ready Infrastructure

A Case Study in Contract Manufacturing with PCT Services

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This Client required a new controlled environment room (CER) space with a GMP-compliant infrastructure to create cell production banks and manufacture allogeneic stem cell products for clinical trials. However, the Client faced numerous time, cost, and dilution/distraction challenges that made handling the expansion internally problematic.

Hitachi Chemical Advanced Therapeutics Solutions provided the client with cGMP support, including the provision of two dedicated ISO 7/Class 10,000 CERs at the PCT Mountain View facility in California. Through collaboration, Hitachi Chemical Advanced Therapeutics Solutions helped the Client rapidly advance their clinical trial program and acquire an excellent ROI on their cell therapy product.

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