Webinar: Comparability Studies: The Key to a Biosimilar's Success
Sponsored by: Covance
Focused on:
Date: 27th November
Days old: 4453
Time: 3PM London / 10AM New York
Analyzing the key issues in product characterization with reference drugs
Biosimilars are products that are highly similar to reference products without clinically meaningful differences in safety, purity and potency. The recent FDA draft guidance outlines the FDA’s “totality-of-the evidence†approach, the cornerstone of which is the structural and functional analyses of the proposed molecule demonstrating comparability with the reference drug. This assessment should include physico-chemical characterization, biological activity, preclinical in vivo studies and clinical comparability.
The analytical characterization should include primary, secondary, tertiary and quaternary structural assessment, biological activity and analysis of product and process impurities.
The presentation will include case studies demonstrating lot to lot differences identified using techniques for assessing these parameters.
This webinar will explore key considerations in comparability studies:
• The current regulatory specifications
• Considerations in physico-chemical characterization
• Considerations in cell-based assay studies
Presented by
Raymond Kaiser, PhD,
Global Vice President, BioPharmaceutical CMC Solutions, Covance
Dr. Raymond Kaiser is the head of BioPharmaceutical CMC Solutions at Covance. Dr. Kaiser is an expert in the research, development, QA/QC and technical support of biologic, biosimilar and vaccine products. He has spent over 20 years in the biopharmaceutical industry and published over 50 papers and patents on various aspects of the development, characterization and manufacture of biologics and vaccines.
Prior to joining Covance, Dr. Kaiser was Executive Director in the Bioprocess R&D Department at Merck Research Laboratories. He had responsibilities for the development of novel vaccine and therapeutic protein processes, assays and products. Prior to joining Merck, Dr. Kaiser was with Wyeth and Eli Lilly.
Dr. Kaiser is also an expert in application of six sigma methodologies to the optimization of pharmaceutical and business systems as well as application of statistical and Quality by Design principles to development.
Download Slides
Please login to download the slidesKey Learning Objectives
- The current regulatory specifications
- Considerations in physico-chemical characterization
- Considerations in cell-based assay studies
- Case studies demonstrating lot to lot differences identified using chemistry- and cell-based techniques for assessing comparability
Audience
- CEO/President/Chairman/Executive Director
- R&D Executives
- CMC development
- Product Characterization
- Nonclinical and Clinical Development Personnel focused on Biosimilars