SOURCE: Xtalks

Xtalks Webinars

May 22, 2015 07:30 ET

Comprehensive Identification and Quantification of Host Cell Proteins by Mass Spectometry, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - May 22, 2015) - Join keynote speaker Daniel Chelsky, Chief Scientific Officer at Caprion Proteomics, for a live session on Monday, June 8, 2015 at 11am EDT (4pm BST/ GMT +1).

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 individual host cell proteins (HCP) and other protein impurities, without affinity-based bias.

Caprion is applying its expertise in proteomics to provide comprehensive identification and quantitation of individual HCPs throughout process development and manufacturing. Caprion's mass spectrometry-based HCP workflow begins with a discovery phase to detect and identify host cell proteins in any of multiple processing steps as well as in the final drug product. The method is applicable to DS generated in CHO, yeast or E. coli host cells. Two orthogonal fractionation methods are used to partition the DS from the lower abundance HCPs, thereby increasing coverage without removing the DS and any DS-bound impurities. The relative abundance of each HCP is determined in comparison to other HCPs within the same sample as well as between processing steps, manufacturing sites, host strains, culture media or other process variables of interest.

The discovery phase is followed by the development of a targeted multiple reaction monitoring (MRM) mass spectrometry assay, which utilizes heavy isotope-labeled peptide standards to accurately quantify and positively identify each of the host cell proteins of interest. Typically, up to 50 proteins are selected for this assay, based on their relative abundance in the discovery study as well as on their biology or likely immunogenicity. Since detection is protein sequence-based, the DS can be easily distinguished from related host proteins. The MRM assay can be deployed on a routine basis to provide more detailed and orthogonal characterization of HCPs, as needed during process development and scale-up.

Examples will be shown illustrating the value of this approach for:

  • Identification and quantification of HCP in the low ppm range
  • Demonstration of HCP clearance
  • Assessing the impact of process changes
  • Determining batch reproducibility
  • Comparison of manufacturing sites

The complimentary one hour session includes a Q&A with the audience. To learn more about this event visit: Comprehensive Identification and Quantification of Host Cell Proteins by Mass Spectometry

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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