Biologics are a diverse and a complex set of therapeutic products that are, or are derived from, living entities. Their complexity cannot often be easily defined, but it is directly related to their function. Often the best way to assess a Biologics’ function is to monitor its behavior in a cell-based assay. Such assays provide a surrogate system for a Biologics’ in vivo mechanism of action and thus are related to its intended therapeutic effect.
This webinar will provide an overview of the utility of cell-based assays used during Biologics development from discovery and preclinical studies through commercial launch.
- Understand the basic considerations in developing cell-based assays for Biologics
- Advantages of implementing ready-to-use cell formats for bioassay applications
- Application of cell-based assays for Lot release and stability testing
- Overcoming challenges in developing and validating cell-based assays
- Managing cell-based assays from sample analysis through final report submission
Dr. Eric Bonner
Eurofins Bioanalytical Services
Dr. Bonner serves as a Scientific Director and technical advisor for both clients and internal teams in managing bioassays from development, to validation and application. He received his Ph.D. in Biochemistry from the University of Illinois and has expertise in a wide variety of fields including protein chemistry, molecular biology, microbiology, and immunology. He has scientific expertise in validating PK and biomarker assays, both single-plex and multi-plex, across a variety of analytical platforms. Additionally, Dr. Bonner has expertise in validation of anti-drug antibody assays, with a particular focus on the application of statistical methods for cut point determination.
Jane Lamerdin, Ph.D.
Director, R&D, EFC Division of Eurofins DiscoverX
Dr. Lamerdin leads a diverse group of scientists responsible for the development of novel cell-based assays for discovery as well as qualification of bioassays for lot release and neutralizing antibody applications. Jane has over 18 years of experience in industry generating cell-based assays to support large and small molecule drug discovery, particularly in the oncology, immunooncology and inflammation therapeutic areas. She received her Ph.D. from the University of California, Davis in Genetics, and has broad expertise in molecular and cellular biology, systems biology/signal transduction, high throughput screening, high content imaging, and diverse reporter and phenotypic assay formats.
Cost: No Cost!