A Mass Spectrometry (MS) based approach in response to recent regulatory guidance

BioPharmaSpec, a leading contract research organization (CRO) providing a full range of characterization services for the biotechnology industry, has announced the launch of “The BioPharmaSpec Approach” for MS-based detection of Host Cell Proteins (HCPs). The new in-house service allows Clients access to a pre-existing approach that detects a wider population of HCPs than possible with traditional ELISA technologies.

In contrast to HCP-ELISA, which relies on the presence of polyclonal antibodies for positive HCP detection, The BioPharmaSpec Approach has the distinct advantage of detecting HCPs in a de novo manner, without specialized polyclonal antibody reagents or product / process-specific method development. BioPharmaSpec apply their renowned MS expertise within a clearly-defined, staged approach, which includes:

1. Qualitative analysis to identify the HCPs present
2. Quantitation against a response from a known spiked protein
3. Quantitation of the HCPs against heavy labeled marker peptides

The application of this in-house service was discussed briefly ahead of the formal launch by BioPharmaSpec’s Technical Director for Structural Analysis, Dr. Richard Easton, during a live webinar entitled: “Characterizing Protein Impurities”. The webinar featured case studies of characterizing process related impurities, with an emphasis on Host Cell Proteins. Scientists can watch this webinar on-demand.