Spectral Sleuthing: latest insights in HCP MS analysis

Christina Morris, BioPharmaSpec, Jersey, UK (c.morris@biopharmaspec.com)

The proteins from host cell expression systems used to produce biopharmaceuticals will co-express or co-purify with the product material, potentially impacting patient safety and/or product quality. Industry guidelines therefore require the identification and monitoring of process-related impurities in product development, including host cell proteins (HCPs). Typically, HCPs are identified as either part of a routine evaluation or as a result of root cause drivers where total levels may be high or product stability issues have been observed. Mass Spectrometric analysis can be run as an orthogonal approach to multi-analyte (total) ELISA, to identify individual HCPs and achieve greater coverage and knowledge of the HCP profile of a biopharmaceutical. In doing so, on-line liquid chromatography mass spectrometry (LC‐MS) analysis can help to improve the risk assessment associated with a product, thereby assisting with significant decisions during process development. The strategies and rationale for implementing HCP-MS analysis will differ depending on the product, process and other project-specific variables. This talk will include discussion of LC-MS data expectations, with reference to the latest USP 1132.1 Chapter updates. We will also highlight methods used at BioPharmaSpec to target and monitor ‘high risk’ HCPs which are especially important to classify, and from which there has been extensive discussion in terms of their potential impact.  

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Short Biography of Presenting Author

Christina completed her undergraduate and graduate studies at Imperial College in London, UK obtaining her PhD in Biomedical Engineering in 2013. She worked on an Artificial Pancreas project gaining experience in hormone regulation for biologically-inspired medical technologies which also included the development of mass-spectrometric techniques for the measurement of glucagon and insulin from pancreatic tissue. At BioPharmaSpec, Christina has largely focused over the last 7 years on residuals analyses including host cell proteins, using different quantitative mass spectrometry techniques.