Pohl, Thomas, Gervais, Annick, Dierksen, Eef, D'Alessio, Valerio, Bechtold-Peters, Karoline, Burkitt, Will, Cao, Li, Greven, Simone, Lennard, Andrew, Li, Xue, Lössner, Christopher, Niu, Ben, Reusch, Dietmar, O'Riordan, Tomas, Shearer, Justin, Spencer, David, Xu, Wei and Yi, Linda (2023) Technical 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, 188. pp. 231-242. 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 good manufacturing practice (GMP) due to limited experience and level of comfort with the technical, compliance and regulatory aspects of its implementation at quality control (QC) laboratories. Here, current literature related to the development and application of the multi-attribute method by peptide mapping liquid chromatography mass spectrometry (MAM) is compiled with the aim of providing guidance for the implementation of MAM in a QC laboratory. This article, focusing on technical considerations, is the first part of a two-tiered publication, whereby the second part will focus on 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:	Liquid chromatography mass spectrometry; Multi-attribute method; Quality control; New peak detection; Critical quality attributes
Date Deposited:	20 Jun 2023 00:45
Last Modified:	20 Jun 2023 00:45
URI:	https://oak.novartis.com/id/eprint/49632