Overcoming Comparability Issues in Regenerative Medicines Manufacturing – Webinar Recording/ Transcript
Overcoming Comparability Issues in Regenerative Medicines Manufacturing: The Latest on Cell and Gene Therapy Regulation
Comparability studies may be the most significant challenge in the development and commercialization of regenerative medicine products — and the difficulties only become more pressing as development progresses. In the course of gaining final approval, a product’s materials and methods will likely evolve. These evolutions may improve the therapy, but they risk its critical quality attributes, or CQAs. Comparability studies mitigate those risks and allow manufacturers to retain those CQAs. A successful study will match the level of changes, with stricter comparability needed as greater adjustments accumulate.
Do you thoroughly understand comparability requirements and how to meet them?
In this FDAnews presentation, Scott R. Burger will discuss how to best navigate the FDA’s stipulations around these studies. He will share best practices around determining the necessary level of your comparability study, planning and preparing for your analysis, and avoiding common mistakes in a package for the FDA.
Key Presentation Takeaways:
- FDA Requirements for Comparability Studies
- Assembling the best comparability package
- Best practices around comparability study risks
- Determining the necessary rigor of a comparability study
- Using the right analytical tools, samples, and statistical analyses
- In vitro versus in vivo comparability studies
- Understand common mistakes and how to avoid them
Managing comparability studies to achieve approval for regenerative medicine products is a complicated but imperative process. Ensure your products retain their CQAs and meet all FDA requirements.
Meet Your Presenter:
Scott R. Burger, MD, is the principal of Advanced Cell and Gene Therapy, a consulting firm specializing in the development, manufacturing, and regulatory affairs of cell and gene therapy products. Mr. Burger has more than 25 years of experience developing these products and has consulted for over 140 companies in North America, Europe, Asia, and Australia. He has directed and consulted on process development, manufacturing, and CMC regulatory aspects of a wide range of cell and gene therapy products, including CAR T-cell, NK, and DC immunotherapies, gene-edited cell therapy products, and stem cell- and somatic cell-based regenerative medicine products.
Who Will Benefit:
- Pharmaceutical and biopharma staff developing cell and gene therapy products
- Product and service providers supporting cell and gene therapies
- Cell and gene therapy CMOs and CDMOs
- Quality and regulatory affairs staff
- Manufacturing process development and analytics staff
- Research and development staff
- Senior management at companies developing cell and gene therapies