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Manufacturing and characterizing the quality of regenerative medicine products often involve measuring as many endpoints as possible, but this approach has proved to be inadequate and unsustainable. Accordingly, an ad hoc planning committee of the National Academies of Sciences, Engineering, and Medicine was assembled to hold a public workshop on the topic. This workshop explored how cross-disciplinary systems thinking approaches can support the identification of relevant quality attributes and streamline manufacturing and regulatory processes of regenerative medicine products.
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Regenerative medicine products, which are intended to repair or replace damaged cells or tissues in the body, include a range of therapeutic approaches such as cell- and gene-based therapies, engineered tissues, and non-biologic constructs. The current approach to characterizing the quality of a reg...
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