Detecting Residual HCPs Demands a Holistic Approach

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BioPharm International, BioPharm International, 2021 Biopharmaceutical Analysis eBook, Volume 2021 eBook, Issue 3
Pages: 20–24

Gene therapy products present a unique set of challenges for the control of host cell protein impurities.

In biopharmaceutical products, residual host cell proteins (HCP) are inevitable impurities.

Viral vector-based gene therapy products, however, present additional HCP control challenges, especially those intended for severe indications and placed on an accelerated development pathway. Time-to-market pressures may conflict with the timelines required to develop a product-specific immunoassay.

HCP content is a critical quality attribute highly relevant to the safety of a gene therapy product. The authors present a holistic approach to ensure that the analytical methods used in process development and quality control are suitable for their intended use by providing accurate results.

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The points that should be considered for a risk mitigation strategy are presented, including a discussion on the use of generic immunoassay kits versus project-specific assays.

Read this article in BioPharm International’s July 2021 Biopharmaceutical Analysis eBook.

About the authors

Olaf Stamm, PhD, is scientific advisor, biologics testing; Andrew Hanneman, PhD, is scientific advisor, biologics testing; Art Cansizoglu, PhD, is senior scientist, and Thorsten Strahl is supervisor protein and scientific officer, all with Charles River.

Article Details

BioPharm International
eBook: Biopharmaceutical Analysis, July 2021
July 2021
Pages: 20–24

Citations

When referring to this article, please cite it as O. Stamm, et. al., “Detecting Residual HCPs Demands a Holistic Approach," BioPharm International Biopharmaceutical Analysis eBook (July 2021).