NDLI: Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics

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Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics

Content Provider	Springer Nature Link
Author	Jenkins, Rand Duggan, Jeffrey X. Aubry, Anne Françoise Zeng, Jianing Lee, Jean W. Cojocaru, Laura Dufield, Dawn Garofolo, Fabio Kaur, Surinder Schultz, Gary A. Xu, Keyang Yang, Ziping Yu, John Zhang, Yan J. Vazvaei, Faye
Copyright Year	2014
Abstract	This paper represents the consensus views of a cross-section of companies and organizations from the USA and Canada regarding the validation and application of liquid chromatography tandem mass spectrometry (LC-MS/MS) methods for bioanalysis of protein biotherapeutics in regulated studies. It was prepared under the auspices of the AAPS Bioanalytical Focus Group’s Protein LC-MS Bioanalysis Subteam and is intended to serve as a guide to drive harmonization of best practices within the bioanalytical community and provide regulators with an overview of current industry thinking on applying LC-MS/MS technology for protein bioanalysis. For simplicity, the scope was limited to the most common current approach in which the protein is indirectly quantified using LC-MS/MS measurement of one or more of its surrogate peptide(s) produced by proteolytic digestion. Within this context, we considered a range of sample preparation approaches from simple in-matrix protein denaturation and digestion to complex procedures involving affinity capture enrichment. Consideration was given to the method validation experiments normally associated with traditional LC-MS/MS and ligand-binding assays. Our collective experience, thus far, is that LC-MS/MS methods for protein bioanalysis require different development and validation considerations than those used for small molecules. The method development and validation plans need to be tailored to the particular assay format being established, taking into account a number of important factors: the intended use of the assay, the test species or study population, the characteristics of the protein biotherapeutic and its similarity to endogenous proteins, potential interferences, as well as the nature, quality, and availability of reference and internal standard materials.
Starting Page	1
Ending Page	16
Page Count	16
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	17
Issue Number	1
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2014-11-13
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Biochemistry Biotechnology Pharmacy
Content Type	Text
Resource Type	Article

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