The Influence of Mass Spectrometry in Development of a Host Cell Protein Monitoring Program for Pharmaceutical Development

The utility of LC-MS in Discovery and targeted modes will be explored for pharmaceutical process and analytical development. The clearance of residual host cell proteins (HCPs), typically introduced from the host cells used to produce the biotherapeutics, is important and usually monitored by enzyme-linked immunosorbent assay (ELISA). Antibodies for ELISA must have suitably comprehensive coverage (immunoreactivity) against the HCP impurities to enable effective monitoring of process clearance. Liquid chromatography-Mass Spectrometry (LC-MS) based analytical methods coupled with affinity purification can be used not only to detect HCPs in Drug Substance but also to monitor reduction of HCPs through purification processes and to assess the HCP coverage of antibody reagents. These methods can be used to assess different antibody reagents for routine ELISA testing and can also be used to elucidate if the coverage is sufficient for a commercial program. Examples of antibody coverage determination, absolute quantification using MRM in DS as well as root cause analysis of impurities will be shared.

For Research Use Only. Not for use in diagnostic procedures.