With the FDA approval of the first two cell therapies and several in the pipeline, therapeutic cells have rapidly emerged as a critical product platform in the biotech and pharma industry. However, for most cell-based therapeutics and regenerative medicine products little is known about their mechanisms of action (MoA), critical quality attributes (CQAs), and critical process parameters (CPPs) that could enable quality-driven manufacturing. In fact, understanding what “quality” means for a particular cell product and how to manufacture those cells with consistent and reproducible quality, at large scale, and at a cost significantly lower than the current approved products are the fundamental challenges facing the cell therapy field. The Center for Cell manufacturing Technologies (CMaT), and NSF-funded Engineering Research Center (ERC) is an eight university public-private consortium that is working closely with industry, academia, and government organizations to enable QbD driven manufacturing of cell therapies by developing new tools and technologies for CQA and CPP identification of complex cell products, real time monitoring of cell-manufacturing processes and products, rapid in-line or at-line analytics, feedback-controlled flexible bioprocessing, efficient supply chain management, scalable manufacturing of the most potent and safe cells, and the development of standards and best practices. In this talk I will provide an overview of our industry-led roadmap to achieve QbD driven cell manufacturing and show specific examples of projects and results from various CMaT funded projects in this area.

Enabling scalable, quality-by-design (QbD)-driven biomanufacturing of cell therapies: 10 year roadmap from the NSF ERC on cell manufacturing technologies (CMaT)

ACS Fall 2020 Virtual Meeting

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