US FDA Recommends Use Of Pre-Built Facilities To Ease Scale-Up Process For Cell And Gene Therapies
As applications for expedited review of cell and gene therapies soar, it is important for their sponsors to take certain steps to enhance prospects for smooth commercial scale-up, the director of US FDA’s center for biologics suggests.
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Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”