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Industry Perspective of International Consortium for Innovation through Quality in Pharmaceutical Development: Complementary LBA and LC-MS Strategies for Large Molecule Protein Bioanalysis and Biotransformation

Kaur, Surinder and Bateman, Kevin and Glick, Jim and Jairaj, Mark and Kellie, John and Sydor, Jens and Zeng, Jianing (2020) Industry Perspective of International Consortium for Innovation through Quality in Pharmaceutical Development: Complementary LBA and LC-MS Strategies for Large Molecule Protein Bioanalysis and Biotransformation. Bioanalysis, 12 (4). ISSN 1757-6180

Abstract

Increasingly diverse large molecule modalities have driven the need for complex bioanalysis involving both traditional ligand binding assays (LBA) and more recent hybrid immunoaffinity liquid
chromatography-mass spectrometry (LC-MS) platforms. Given the scientific expertise in LBA and LCMS typically resides in different functions within the industry, this has presented operational challenges for an integrated approach for bioanalysis. Encouragingly, over time, the industry has recognized the complementary value. This has not been an easy transition as organizational structures vary widely within the industry. However, there are tremendous benefits in adopting fully integrated strategies for biopharma. This paper highlights the technical and operational challenges in current large molecule bioanalysis, value of collaborations across LBA and LC-MS platforms, and scientific expertise for fully integrated strategies.

Item Type: Article
Keywords: biotransformation, hybrid ligand binding LC–MS, immunoaffinity, LC–MS, LC–MS/MS, MS, peptides, proteins
Date Deposited: 07 Apr 2020 00:45
Last Modified: 07 Apr 2020 00:45
URI: https://oak.novartis.com/id/eprint/41595

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