Gervais, Annick, Pohl, Thomas, Dirksen, Eef, Bechtold-Peters, Karoline, Burkitt, Will, D'Alessio, Valerio, Lennard, Andrew, Li, Xue, Lössner, Christopher, Niu, Ben, Reusch, Dietmar, O'Riordan, Tomas, Shearer, Justin, Spencer, David, Wei, Xu and Yi, Linda (2023) Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory. European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 191. pp. 57-67. ISSN 1873-3441

Abstract

Multi-attribute methods employing mass spectrometry are applied throughout the biopharmaceutical industry for product and process characterization purposes but are not yet widely accepted as a method for batch release and stability testing under the good manufacturing practice (GMP) regime, due to limited experience and level of comfort with the technical, compliance and regulatory aspects of its implementation at quality control (QC) laboratories. This article is the second part of a two-tiered publication aiming at providing guidance for implementation of the multi-attribute method by peptide mapping liquid chromatography mass spectrometry (MAM) in a QC laboratory. The first part [1] focuses on technical considerations, while this second part provides considerations related to GMP compliance and regulatory aspects. This publication has been prepared by a group of industry experts representing 14 globally acting major biotechnology companies under the umbrella of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing & Quality Expert Group (MQEG).

Item Type:	Article
Keywords:	Laboratories Mass Spectrometry Drug Industry Chromatography, Liquid Quality Control
Date Deposited:	20 Feb 2024 00:45
Last Modified:	20 Feb 2024 00:45
URI:	https://oak.novartis.com/id/eprint/50837