Author Archives: Jared Isaac

An Effective Orthogonal Method for Host Cell Protein Analytics

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Host cell proteins (HCPs) can copurify with a biological drug substance (DS), posing potential risks for both patients and drug manufacturers. Although many HCPs are benign, some are immunogenic, others can interact with a DS and diminish its efficacy, and others can interfere with DS stability. Thus, the quantity and nature of residual HCPs in a DS generally are considered to be critical quality attributes (CQAs) that constitute a significant part of a drug developer’s overall risk-management strategy (1–5). HCP…

August 17, 2023

Investigation of HCP Enrichment During CGMP Scale-Up

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On paper, scaling a bioprocess from a 10-L to a 100-L to a 2,000-L bioreactor may seem like a straightforward math problem that could be solved by software. In practice, however, the exercise relies on a complex set of biological, chemical, and engineering assumptions; on maintenance of healthy cell cultures; and on management of equipment and analytics while adjusting to each increase in scale (1). Process development and quality control groups need to monitor how scale-up might affect critical quality…

October 20, 2022

Host Cell Protein Analysis: Immunoassays and Orthogonal Characterization By Antibody Affinity Extraction and Mass Spectrometry Methods

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Reduction of Host Cell Proteins (HCPs) to the lowest levels practical requires sensitive and robust analytical methods. In this Special Report, Cygnus Technologies discusses industry best practices for HCP analysis and integration of orthogonal methods for in-depth HCP characterization using Antibody Affinity Extraction (AAE) and Mass Spectrometry (MS). Download the report to learn about: Antibody Affinity Extraction for HCP antibody coverage analysis to ensure HCP ELISA is broadly reactive and fit for purpose of process monitoring and product lot release…

August 17, 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