Regulatory and Technical Considerations for Effective Monitoring of Host Cell Protein Impurities
Accurate monitoring of host cell proteins (HCPs) in biologic drugs is challenging given the need to assay for hundreds or thousands of unknown host proteins present at trace levels in the background of a vastly abundant biologic protein. The most widely used method for determining the presence of HCPs is ELISA, which employs a combination of polyclonal antibodies raised against host cell protein mixtures.
Even trace levels of HCPs can have deleterious effects on safety or efficacy of biologic drug administration to human patients. Several recent examples of impurities missed by ELISAs have raised regulatory attention to HCP monitoring strategies. In the context of growing regulatory attention, this presentation will introduce robust technical approaches to qualify HCP ELISAs and orthogonal methods to effectively monitor host cell protein impurities missed by ELISAs.
In this webinar, you will learn:
1. More about the regulatory requirements for effective removal and accurate monitoring of process derived impurities, such as host cell proteins (HCPs)
2. Approaches to qualify HCP ELISAs and orthogonal methods to effectively monitor host cell protein impurities missed by ELISAs
3. Bio-Rad’s complete workflow solution for qualifying anti-HCP antibodies by 2D electrophoresis and western blotting.
Register today!
Presented by
Sricharan Bandhakavi, Ph.D.,
Global Product Manager, Applications and Collaborations
Dr. SricharanBandhakavi (Sri) received his PhD in 2001 from the University of Georgia in Biochemistry and Molecular Biology. He completed a post-doctoral appointments at Northwestern University from 2002-2003. Subsequently, he moved to the University of Minnesota where he was a Senior Research Associate/Staff Scientist (2004-2009) and then Assistant Professor (2009-2010). At the above positions, Sri worked on molecular/genetic approaches to eukaryotic cellular signalling and the development of large-scale LC-MS and orthogonal proteomic technologies for quantitative (differential analysis of protein-protein interactions and protein abundance) and descriptive studies (identification of protein and PTM constituents) in cellular systems and biologic fluids.
Sri joined Bio-Rad Laboratories in 2010, wherein he has worked as Senior Scientist and Global Product Manager - Collaborations and Applications. At Bio-Rad, he has focused on new technologies R&D, protein analytical methods development and coordinating a global network of collaborations for developing high quality solutions for life science and pharmaceutical applications.
Sri has authored >30 scientific publications including highly cited peer-reviewed papers (>1250 citations to date) and patent applications, spoken/presented at a variety of international conferences & meetings, and regularly reviews submitted manuscripts to peer-reviewed journals in the fields of proteomics and molecular/cellular biology.
