Analytical Quality by Design, Life Cycle Management, and Method Control.

Autor: Verch T; Merck & Co., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, United States of America. Thorsten_verch@merck.com.; Merck & Co., Inc., 770 Sumneytown Pike, WP45-1127, WP, Pennsylvania, 19486, United States of America. Thorsten_verch@merck.com., Campa C; GSK, GlaxoSmithKline, Via Fiorentina 1, 53100, Siena, Italy., Chéry CC; UCB, Pharma SA, Chemin du Foriest, 1420, Braine-l'Alleud, Belgium., Frenkel R; Biogen, 255 Binney St, Cambridge, MA, 02142, United States of America., Graul T; Pfizer Inc., Eastern Point Road, Groton, CT, 06340, United States of America., Jaya N; Seattle Genetics, 21823 - 30th Drive SE, Bothell, WA, United States of America, 98021., Nakhle B; Biogen, 255 Binney St, Cambridge, MA, 02142, United States of America., Springall J; AstraZeneca, 950 Wind River Lane, Gaithersburg, MD, 20876, United States of America., Starkey J; Pfizer Inc., 875 W. Chesterfield Parkway, Chesterfield, MO, 63017, United States of America., Wypych J; Amgen Inc., One Amgen Center Drive, MS 30E-1-C, Thousand Oaks, Canada, 91320, United States of America., Ranheim T; Resilience, 9310 Athena Circle, La Jolla, Canada, 92037, United States of America.
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2022 Feb 11; Vol. 24 (1), pp. 34. Date of Electronic Publication: 2022 Feb 11.
DOI: 10.1208/s12248-022-00685-2
Abstrakt: Analytical methods are utilized throughout the biopharmaceutical and vaccines industries to conduct research and development, and to help control manufacturing inputs and outputs. These analytical methods should continuously provide quality data to support decisions while managing the remaining of risk and uncertainty. Analytical quality by design (AQbD) can provide a systematic framework to achieve a continuously validated, robust assay as well as life cycle management. AQbD is rooted in ICH guidelines Q8 and Q9 that were translated to the analytical space through several white papers as well as upcoming USP 1220 and ICH Q14. In this white paper, we expand on the previously published concepts of AQbD by providing additional context for implementation in relation to ICH Q14. Using illustrative examples, we describe the AQbD workflow, its relation to traditional approaches, and potential pathways for ongoing, real-time verification. We will also discuss challenges with respect to implementation and regulatory strategies.
(© 2022. The Author(s).)
Databáze: MEDLINE
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