Abstract
Cell and gene therapies (CGTs) have revolutionized patient outcomes and provided careoptions for previously untreatable conditions. The clinical and commercial progress of CGT therapies is hindered bychemistry, manufacturing, and control (CMC) challenges. This article summarizes recommendations from the 2023 Annual Meeting CMC sessions wherein speakers advocated for science-driven comparability strategies, proactive risk assessments, clearer regulatory guidance, and a shift from retrospective to prospective studies. Planning formanufacturing changes, statistical approaches, and consideration of multiple product versions also emerged as crucial elements to help sponsors navigate CMC hurdles for successful CGT clinical and commercial development.
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