Author Archives: Ken Hoffman

Host-Cell Protein Analytics: History and Future Trends

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Different analytical methods have been developed to detect host-cell proteins (HCPs) in bioprocess streams. Advancements in such methods are enabling biomanufacturers to optimize their purification processes and ensure that their products are safe and efficacious. To celebrate the 20th anniversary of BioProcess International, Ken Hoffman (founder of Cygnus Technologies) provides insights into the history, trends, and future of HCP analytics. History: 1990s to 2022 The recombinant therapeutic protein industry was in its infancy in the early 1990s. HCPs were recognized…

August 22, 2022

Antibody Affinity Extraction Enables Identification of Host Cell Proteins by Mass Spectrometry

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Host cell proteins (HCP) constitute a major group of impurities for biologic drugs produced using cell culture technology. Even at nanogram per milligram concentrations of HCP to drug substance (DS), HCPs can elicit undesired immune response, interfere with drug safety and efficacy, or impact DS stability. A broadly-reactive HCP ELISA should be used during the purification processes to ensure removal of HCPs and to demonstrate process consistency and final DS purity. Regulatory authorities are requesting biopharmaceutical companies employ orthogonal methods…

August 1, 2019

Letter to the Editor

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The following letter came in response to recent articles on lot-release testing and host-cell proteins: Schwertner D, Kirchner M. Are Generic HCP Assays Outdated? BioProcess Int. 8(5) 2010: 56–62. Rieder N, et al. The Roles of Bioactivity Assays in Lot Release and Stability Testing. BioProcess Int. 8(6) 2010:33–42. Members of our peer-review board recommended publishing this longer than average communication. A Rational Approach to Process-Specific Host-Cell Protein Detection So-called generic host-cell protein (HCP) antibodies and assay kits have proven to…

December 1, 2010