Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access.

Autor:	Algorri M; Department of Global Regulatory Affairs and Strategy-CMC, Amgen Inc, Thousand Oaks, California 91320, USA., Abernathy MJ; Department of Global Regulatory Affairs and Strategy-CMC, Amgen Inc, Thousand Oaks, California 91320, USA., Cauchon NS; Department of Global Regulatory Affairs and Strategy-CMC, Amgen Inc, Thousand Oaks, California 91320, USA. Electronic address: ncauchon@amgen.com., Christian TR; Process Development, Amgen Inc, Thousand Oaks, CA 91320, USA., Lamm CF; Global Regulatory Affairs-CMC, Merck & Co., Inc., Kenilworth, New Jersey, 07033, USA., Moore CMV; Global Quality and Compliance, Organon, Jersey City, New Jersey, 07302, USA.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2022 Mar; Vol. 111 (3), pp. 593-607. Date of Electronic Publication: 2021 Aug 31.
DOI:	10.1016/j.xphs.2021.08.032
Abstrakt:	The traditional paradigm for pharmaceutical manufacturing is focused primarily upon centralized facilities that enable mass production and distribution. While this system reliably maintains high product quality and reproducibility, its rigidity imposes limitations upon new manufacturing innovations that could improve efficiency and support supply chain resiliency. Agile manufacturing methodologies, which leverage flexibility through portability and decentralization, allow manufacturers to respond to patient needs on demand and present a potential solution to enable timely access to critical medicines. Agile approaches are particularly applicable to the production of small-batch, personalized therapies, which must be customized for each individual patient close to the point-of-care. However, despite significant progress in the advancement of agile-enabling technologies across several different industries, there are substantial global regulatory challenges that encumber the adoption of agile manufacturing techniques in the pharmaceutical industry. This review provides an overview of regulatory barriers as well as emerging opportunities to facilitate the use of agile manufacturing for the production of pharmaceutical products. Future-oriented approaches for incorporating agile methodologies within the global regulatory framework are also proposed. Collaboration between regulators and manufacturers to cohesively navigate the regulatory waters is ultimately needed to best serve patients in the rapidly-changing healthcare environment. Competing Interests: Conflicts of Interest MA, MJA, NSC, and TRC are employees of Amgen Inc. CFL is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD). CMVM is an employee of Organon. All authors contributed to the writing of the report, approved the final version of the manuscript, and agreed to submit the manuscript for publication. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu