Bioanalytical Tools for Biosimilar Development
In this webinar, you will learn about:
- The distinct process by which similar drugs are developed
- Cell-based bioassays that enable determination of functional biosimilarity to reference products
- Protein characterization tools for rapid and reliable mass spectrometry-based analysis of biosimilar structure
Summary
Biologic therapeutics have revolutionized the treatment of cancer and immune-mediated inflammatory diseases. As patent protections on innovator biologics expire, global drug manufacturers are ramping up the development of follow-on drugs known as biosimilars. These therapeutic agents are highly similar to the original patented biologic in structure and function. Because of the complex structure and inherently variable processes by which innovator biologic and biosimilar drugs are manufactured, robust characterization tools are essential. Biosimilar development, in particular, requires extensive analytical comparison of a drug’s structure and function to ensure biosimilarity to its reference product. This webinar will explore analytical tools that enable drug developers to bring these biosimilar products to market, thereby and ensuring patients have access to high-quality, cost-effective therapeutics. The webinar includes a live Q&A session.
Speaker
Jeff Nelson, PhD
Biologics Product Manager
Jeff Nelson is a product manager in the biologics group at Promega. Jeff manages the cytokine and growth factor bioassays as well as the new Lumit™ immunoassays directed toward biologics drug development. Prior to joining Promega, Jeff was an R&D scientist at Stem Pharm, a company creating synthetic biomaterials for cell and tissue manufacturing. Jeff received his PhD in Biology from the University of California, San Diego and completed post-doctoral studies at the Morgridge Institute for Research.