Cambridge Healthtech Institute’s 5th Annual

Host Cell Proteins

Detection, Analysis and Control

August 24-25, 2020

 

Controlling process-related impurities, such as host cell proteins (HCPs), is a critical part of bioprocessing. Analytical methods are available, but coverage and specificity is limited. Moreover, the emergence of new techniques, such as mass spectrometry, has further compounded these limitations with regulators now pressing companies for more HCP data.

CHI’s Host Cell Proteins conference brings together industry leaders to discuss critical HCP topics, such as: risk assessment and control strategies, HCP characterization, assay coverage, critical reagents and platforming, plus questions relating to advanced therapies, biosimilars, in-process testing, and the latest data supporting the link between HCPs and immunogenicity.

 

Cover will include, but is not limited to:

  • Regulatory considerations for HCPs – advice from regulatory authorities
  • Risk assessment strategies across companies
  • Impact of process development on HCPs
  • HCPs for gene therapies
  • Control strategies
  • Process development strategies to control HCPs
  • In-Process testing
  • Integrating HCP testing into a platform
  • HCP characterization
  • Mass spectrometry
  • Industry application
  • Improving label-free quantification
  • Assay development
  • Assay coverage
  • Critical reagents
  • When to change assays
  • Criteria for bridging
  • HCPs, biosimilars, and comparability testing

 

* The program is subject to change without notice, due to unforeseen reason.





Premier Sponsors:

NanotemperTechnologies

Vironova