Webinar: Challenging host cell protein assays for improved risk mitigation

Host cell proteins (HCP) are critical to quality control in biologics development. If left unremoved, they can cause immunogenic responses and reduce drug efficacy.

This presentation will share Cytiva’s strategy for designing a comprehensive HCP risk mitigation strategy. It will address how to challenge your assays early to ensure accurate measurements, build confidence, and reduce the risk of unexpected HCP levels.

Learning objectives:
• Discuss indicators of robustness and compatibility in enzyme-linked immunosorbent assays (ELISA) with process-specific samples
1) Demonstrating dilutional linearity across the purification process
2) Detecting potential detrimental effects of the sample matrixo
3) Ensuring accurate interpolation of HCP concentration from the standard curve
• Show how different HCP ELISA kits detect varying HCP levels across commercial drug substances, reinforcing the importance of assay selection
• Outline ways to measure HCP antibody coverage as required by regulatory authorities
• Explore the benefits of using a large gel format for reporting coverage data

Speakers:

Andrew Hamilton, PhD, Scientist, Imaging and Western Blotting. Cytiva
Andrew is a biochemist with a background in glycobiology, protein interactions, and angiogenesis. He joined GE Healthcare Life Sciences, now Cytiva, in 2017, where he has focused on developing host cell protein ELISAs and validation assays for the past three years. Andrew received his PhD in cardiovascular medicine from Manchester University in 2011, and then moved to Uppsala, Sweden for his postdoctoral training at Uppsala University.

Joe Hirano, PhD, Program manager, Imaging and Western Blotting, Cytiva
Joe Hirano is a program manager at Cytiva based in Uppsala, Sweden, where he coordinates products and their applications between R&D and external collaborators to support customers. Since joining the company in 2000, Joe has been working with genomics, protein research, and biomanufacturing products, including electrophoresis, Western blot, imaging, and upstream and downstream bioprocess products. His current focus is on the analysis of host cell protein and other impurities. Before joining the biopharma industry, Joe studied marine biology as a research scientist.