Host Cell Proteins: Analytical and Regulatory Challenges

***Live: Wednesday, Oct. 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST*** Host cell proteins (HCPs) can compromise a biologic drug and delay its development program. Learn about important considerations for optimizing HCP testing in this webcast. ***On demand available after final airing until Oct. 21, 2021***

Register free: https://www.biopharminternational.com/bp_w/regulatory_challenges

Event Overview:

A critical task in biologics manufacturing is the control of process-related impurities, such as host cell proteins (HCP), which co-purify with the drug substance and are known to cause adverse effects such as immunogenicity. For decades, the method of choice for detection has been immunoassays based on polyclonal antisera raised against a population of HCPs. Although immunoassays such as enzyme-linked immunosorbent assays (ELISAs) are well established in many quality control applications—especially for HCP determination—there are some inevitable risk factors (antigen, animals, etc.) associated with this approach. The final performance of the HCP assay strongly depends on the preparation work and materials used at the start.

This presentation will look at case studies from more than 20 years of HCP assay development. The discussion will highlight critical parameters and quality attributes along the entire assay development process, such as:

  • Considerations for choosing a suitable antigen, including regulatory and practical requirements
  • Optimizing the immunization process by cascade/subtractive approaches
  • Qualifying antigen and antisera as reagents for GMP-compliant assay development
  • Targeting enhancement of coverage by combining tools from proteomics, protein synthesis, and immunization
  • Using orthogonal tools (mass spectrometry) for direct analysis of HCP impurities

Key Learning Objectives:

  1. Understand the risk factors associated with HCPs in biopharmaceuticals and how to protect against them
  2. Review the process for HCP custom ELISA assay development, including regulatory and practical requirements
  3. Learn how to use orthogonal tools for analysis of HCP impurities

Speaker: Olaf Stamm, Ph.D., MDRA, Senior Specialist Biological Testing Solutions, Charles River

Time and Date: Wednesday, Oct. 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing until Oct. 21, 2021

Sponsor: Charles River

Register free: https://www.biopharminternational.com/bp_w/regulatory_challenges