Meet the regulator: Challenges in reference standard qualification for relative potency assays

Charlotte Mitz , Biologist/Evaluator, Biotherapeutics Quality Division # 4, CBBB, BRDD, HPFB, Health Canada, Ottawa, Canada (cbbbdocorrespondence-cspsbcorrespondance@hc-sc.gc.ca)
Tim Schofield, Na, Retired Expert In Cmc Statistics And Regulatory Science, Md, Usa
Mati Morag, Analytical R&d, Mediwound Ltd., Rehovot, Israel

A reference standard (RS) is used as the foundation for relative potency determination in drug substance and drug product testing and serves as the benchmark against which all samples are measured. Therefore, qualification of a RS for relative potency assays and the determination of an assigned potency value is critical to ensure the intended quality of the product throughout its lifecycle. This criticality is further amplified in the case of biological drug products due to the complexity of their structure and intrinsic properties.  This panel will explore regulatory, scientific, and practical considerations in establishing and maintaining qualified reference standard programs for relative potency bioassays. Key discussion points will include the implementation of a two-tier RS program, comprising primary and working standards, and the common challenges encountered during RS qualification.

The panel will include three short presentations given by the following participants followed by questions from the audience:

• Charlotte Mitz MSc., Biologist/Evaluator, Biotherapeutics Quality Division # 4, CBBB, BRDD, HPFB Health Canada
• Tim Schofield MA, Retired expert in CMC Statistics and Regulatory Science
  
• Mati Morag Ph.D., Executive Director of Analytical R&D, MediWound Ltd.
  

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Short Biography of Presenting Author

Charlotte Mitz MSc., Biologist/Evaluator, Biotherapeutics Quality Division # 4, CBBB, BRDD, HPFB Health Canada

Charlotte Mitz is a Biologist/Evaluator with the Centre for Blood, Blood Products and Biotherapeutics (CBBB) in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada. She holds an MS.c. in Biomedical Sciences (specialization in the field of cellular and molecular biology) from the University of Guelph. Charlotte joined BRDD in 2021 and has since been involved in the evaluation of CMC information for a wide range of biotherapeutic products.
cbbbdocorrespondence-cspsbcorrespondance@hc-sc.gc.ca

Tim Schofield MA, Retired expert in CMC Statistics and Regulatory Science

Tim began his career in the Virus & Cell Biology division of Merck Research Laboratories where he developed a Nonclinical Statistics Group supporting Merck Vaccines and pharmaceuticals.  Due to his interest in the interplay between regulations and industry standards he developed an expertise in CMC regulatory science, resulting in the introduction of a suite of USP General Chapters in bioassay design & development, validation, and data analysis, and a WHO Guidance on stability evaluation of vaccines.  In these and several textbook chapters, articles, and conference presentations, Tim sought to encourage developers and regulators to focus on uncertainty and risk as the basis for a scientific approach to product development and lifecycle management.  Tim has a Master of Arts degree from the Wharton School of the University of Pennsylvania, in Philadelphia, PA, USA.
timothylschofield@gmail.com

Mati Morag Ph.D., Executive Director of Analytical R&D, MediWound Ltd.

Mati Morag studied Analytical Chemistry under the mentorship of Prof. Aviv Amirav at Tel Aviv University, specializing in GC-FID, GC-MS, and advanced analytical techniques. Following his doctoral studies, Mati joined InSight Biopharmaceuticals as an Analytical Chemist, leading a team of analysts in supporting process development for generic antibody production. For the past nine years, Mati has been working at MediWound, initially as a Project Leader and currently serving as Executive Director of Analytical R&D. His work focuses on integrating chromatographic, spectrometric, and bioassay methodologies to support pharmaceutical product development and ensure regulatory compliance.
matim@mediwound.com