AI Article Synopsis
- Analytics for host cell protein (HCP) analysis in monoclonal antibodies have advanced significantly and can inform HCP analysis in gene therapy viral vector products.
- Mass spectrometry (MS) is emerging as a key method for analyzing HCPs in viral vector preparations, but its application is still limited and not yet widely incorporated into development processes.
- As MS techniques improve and data becomes more accessible, they will enhance understanding of the processes involved, helping to reduce HCP levels and assess risks, which will ultimately support the creation of safe and effective gene therapies.
Article Abstract
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.
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| http://dx.doi.org/10.1016/j.copbio.2021.06.026 | DOI Listing |
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