Security Of Supply For Critical Reagents Used In HCP Analysis

The most common method scientists use to monitor host cell protein (HCP) levels in biologics is the enzyme-linked immunosorbent assay (ELISA). For the reagent, security of supply is a regulatory requirement ⁠— it’s a factor that’s critical to consistently monitoring HCP during biologic production. In this webinar, we discuss why security of supply is important, the consequences of not having it, and how to mitigate this risk.

Topics covered

• Why security of supply is critical to your HCP plans
• Consequences of not securing supply upfront
• How to mitigate risk by securing supply distribution
• Differences between antisera batch and ELISA lot

Speakers:

Joe Hirano, PhD
Program manager, Imaging and Western Blotting
Cytiva

Joe Hirano is a program manager at Cytiva based in Uppsala, Sweden, where he manages products and their applications between Research and Development, 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 proteins and other impurities. Before joining the biopharma industry, Joe studied marine biology as a research scientist.

David Chimento, PhD
VP Custom Services
Rockland Immunochemicals

David Chimento leads the custom services division at Rockland Immunochemicals, based in Limerick, Pennsylvania, US. David coordinates and oversees Research and Development engagements for both internal and external stakeholders with a focus on project design and strategy for customers. David joined Rockland Immunochemicals in 2008 and has been working on critical reagent development and assay development. He has a strong interest in creating tools for traditional and emerging biotherapeutics and biomanufacturing. One of his current focus areas is on bioprocessing and the analysis of host cell proteins and other impurities. Before joining the biotechnology industry, David studied microbiology and molecular biophysics with a focus on protein structure and protein-protein interactions.