Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes.

Autor: McCaig L; Pfizer Inc, 21823 30Th Drive SE, Bothell, Washington, 98021, USA., Nowak S; AbbVie, 1 N Waukegan Rd. Bldg. AP50; Dept PA71, North Chicago, Illinois, 60064, USA. steven.a.nowak@abbvie.com., Abbott A; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK., Carhart J; Takeda Development Center Americas, Inc. 95 Hayden Ave, Lexington, Massachusetts, 02421, USA., McMahon ME; Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA., Debie E; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340, Beerse, Belgium., Li H; Vertex Pharmaceuticals, 50 Northern Avenue, Boston, Massachusetts, 02210, USA., Maina F; AbbVie, 1401 Sheridan Road, North Chicago, Illinois, 60064, USA., Ji AJ; Genentech Inc, 1 DNA Way, South San Francisco, California, 94080, USA., Fu M; Sumitomo Pharma America, 84 Waterford Drive, Marlborough, Massachusetts, 01752, USA., Wu Y; Merck & Co, 2000 Galloping Hill Road, Kenilworth, New Jersey, 07033, USA., Lennard A; Amgen Ltd, 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, UK., Mazzeo T; Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, New Jersey, 08903, USA., Wolfe C; Eli Lilly & Company, Lilly Corporate Center, Indianapolis, Indiana, 46285, USA., Timpano R; Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA., Babayan Y; Eli Lilly & Company, Lilly Corporate Center, Indianapolis, Indiana, 46285, USA., Gruenig L; CSL Behring, CSL Behring AG, Wankdorfstrasse 10, CH-3014, Bern, Switzerland.
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2024 Mar 14; Vol. 26 (2), pp. 34. Date of Electronic Publication: 2024 Mar 14.
DOI: 10.1208/s12248-024-00903-z
Abstrakt: ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufacturing and Controls (CMC) post-approval changes (PAC) to enable more timely implementation; however, no guidance or specific examples are provided to demonstrate how prior knowledge of the product can inform the risk assessment for the proposed change(s). Ten diverse case studies are presented in this manuscript to demonstrate how science- and risk-based stability strategies were used to support drug substance and product CMC PAC and lifecycle management activities. The accumulated stability knowledge held by original manufacturers of marketed products is substantial, and different elements of this knowledge base were used to assess the risks and impact of the proposed changes for confident change management. This paper provides ways to leverage science- and risk-based stability strategies as part of the post-approval change-management risk-mitigation strategy, which may enable a reduced stability data commitment and/or a reduced reporting category for change implementation.
(© 2024. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.)
Databáze: MEDLINE
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