Innovation in Chemistry, Manufacturing, and Controls-A Regulatory Perspective From Industry

Journal of Pharmaceutical Sciences
Nina S CauchonMichael Abernathy

Abstract

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through con...Continue Reading

Citations

Nov 27, 2020·Drug Discovery Today·Eline van OverbeekeSteven Simoens
Sep 25, 2020·Journal of Pharmaceutical Sciences·Lucas GutierrezMichael J Abernathy
Nov 12, 2020·Clinical & Translational Immunology·Alba Matas-CéspedesKourosh Saeb-Parsy
Apr 10, 2021·Nature Reviews. Drug Discovery·Cedrik M BrittenAxel Hoos
Sep 4, 2021·Journal of Pharmaceutical Sciences·Marquerita AlgorriChristine M V Moore

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