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Analytics of Host Cell Proteins (HCPs): Lessons from Biopharmaceutical mAb Analysis for Gene Therapy Products

Bracewell, Daniel G., Smith, Victoria, Delahaye, Mike, Smales, Christopher Mark (2021) Analytics of Host Cell Proteins (HCPs): Lessons from Biopharmaceutical mAb Analysis for Gene Therapy Products. Current Opinion in Biotechnology, 71 . pp. 98-104. ISSN 0958-1669. (doi:10.1016/j.copbio.2021.06.026) (Access to this publication is currently restricted. You may be able to access a copy if URLs are provided) (KAR id:89635)

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Analytics for host cell protein (HCP) analysis of therapeutic monoclonal antibody preparations have developed enormously. We consider how learnings from this can inform HCP analysis of gene therapy viral vector products. The application of mass spectrometry (MS) approaches for analysis of HCPs in viral vector preparations is being established, although such information remains limited and is yet to be widely applied into process or host cell line development to reduce HCP amounts or risk. As these MS approaches, and the data from them, are applied and become available, the process understanding created will speed process development activity. We describe technologies that have been, or can be, applied to viral vector HCP analysis to aid process development, reduce HCP amounts, identify critical HCPs and thus inform risk assessment and management based on a knowledge of specific HCPs, ultimately delivering safe and efficacious gene therapy products to the clinic.

Item Type: Article
DOI/Identification number: 10.1016/j.copbio.2021.06.026
Subjects: Q Science
Divisions: Divisions > Division of Natural Sciences > School of Biosciences
Depositing User: Mark Smales
Date Deposited: 05 Aug 2021 10:41 UTC
Last Modified: 06 Aug 2021 14:05 UTC
Resource URI: (The current URI for this page, for reference purposes)
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