BioPharmaceutical Emerging Best Practices Association

Synopsis: BEBPA’s 2023 Host Cell Protein Conference in Review

Volume 1, Issue 2: Dr. Denise Krawitz provided an excellent wrap up on the last day of BEBPA’s 11th Annual HCP Conference held in May 2023 in Dubrovnik, Croatia. Her quick 10-minute summary captured the essence of the conference and highlighted topics covered during the conference, as well as providing a sneak peek into future topics.

Tech Briefing: Mass Spectrometry In HCP Analysis (USP 1132.1)

Host Cell Protein (HCP) analysis by mass spectrometry (LC-MS/MS) has obviously been growing in importance in the last decade. However, LC-MS/MS analysis is generally used for characterization, so the practitioners have been on their own to develop methods that work for their particular applications. HCP analysis has unique challenges that make it different from the MS-based general proteomics or characterization workflows that dominate the biotech and biopharma landscape. In HCP analysis, the analyst is trying to detect parts-per-million level peptides in a vast ocean of drug product (DP) peptides.

Tech Briefing: Working with Host Cell Proteins

Host cell proteins (HCPs) are a complex and diverse group of proteins produced by the cells used in biopharmaceutical manufacturing processes. We’d like to think that analytical methods used for release of a biopharmaceutical product are unambiguous – i.e., methods having well-defined target analyte(s), complete analyte coverage, high specificity, and a high degree of confidence in the results. The HCP ELISA, which is often used as a release assay, barely has any of those desirable traits. So, what other methods can we use to assess the purity of products? Outside of other immunoassays, mass spectrometry (LC-MS/MS) is most used. However, despite all the high-tech features of this method, it also is imperfect, especially when it comes to being a release assay.