Caprion

Finding proteins that hit the mark

ProteoCarta™ HCP Detect Assay

With the rapid expansion of biologics and biosimilars and the accompanying improvements in analytical technologies, there is increasing pressure to better characterize both the process and the final product. In contrast to traditional antibody-based methodologies, such as ELISA and Western blot, mass spectrometry can provide more detailed characterization and quantitation of HCP and other protein impurities. The HCP Detect assay development starts with an unbiased discovery workflow to identify host cell proteins and can include retains from multiple processing steps as well as final drug product. The discovery phase is followed by the development of a targeted MRM mass spectrometry assay, which utilizes heavy isotope-labeled standards to accurately quantify each of the host cell proteins of interest.  The assay can then be deployed on a routine basis to provide more detailed and orthogonal characterization of HCP during process development and manufacturing.

Applications

Development and deployment of multiplexed product-specific assays for detection and quantitation of individual host cell proteins

  • Orthogonal method for Identification of individual HCPs throughout process development
  • Demonstration of HCP clearance
  • Assessment of process changes and manufacturing site differences
  • Absolute or relative quantitation of individual HCPs

Benefits of ProteoCarta HCP Detect

Mass-spectrometry based platform enables deep coverage and superior characterization of HCPs from early process development through manufacturing:

  • Positive identification of HCP and other protein-based process impurities
  • More in-depth understanding of HCP compared to conventional assays
  • Antibody-free approach saves time and eliminates affinity-associated bias
  • Rapid assay development and conversion to a quantitative, multiplexed assay
  • Applicable to mAbs, blood products, peptides and other biotherapeutic proteins

 

 

© 2017 Caprion