In the rapidly expanding arena of biotherapeutic analysis and bioprocess development, the analysis of host cell proteins (HCP) is transitioning to a new phase. HCPs are contaminants in biotherapeutic drug preparations, often at low ppm concentration levels, and must be monitored due to stability, efficacy and immunogenicity concerns. Often, these protein impurities will be considered Critical Quality Attributes (CQA) and can contribute to an overall risk assessment for the product.
Immunospecific assays such as ELISA are currently the gold standard for QC applications, but there are long lead times for new assays based on process changes. The main advantage of mass spectrometry is the ability for unbiased, highly sensitive detection, although this generally comes at the cost of very long run times.