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.

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).