From concept to clinic: overcoming the challenges of potency assays in cell and gene therapy development

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Potency assays play a critical role in measuring the biological activity of cell and gene therapies (CGTs), ideally aligning with the desired mechanism of action (MOA). These assays must provide quantitative data related to drug dose, reflect product quality and stability, and ultimately demonstrate clinical efficacy. However, unlike traditional biologics, such as recombinant proteins or monoclonal antibodies, CGTs present unique challenges due to the complexity of both the drug substance and the manufacturing process. This complexity makes selecting, developing, and validating potency assays significantly more difficult.

To address these challenges, the FDA issued a draft guidance in December 2023, titled "Potency Assurance for Cellular and Gene Therapy Products," which marks a shift from a single potency test approach to a comprehensive potency assurance strategy. This guidance emphasizes the importance of multiple product-specific potency assays to be used throughout various stages, including product development, comparability studies, product release, stability testing, and clinical dose/efficacy evaluations.

This webinar will explore the intricacies of potency assays in CGT, focusing on the regulatory framework and practical strategies for assay development, qualification, and validation. Case studies with real life practices for successfully transferring, qualifying, and validating GMP potency assays to ensure clinical and commercial success will be presented.

Join us to gain a deeper understanding of how to navigate this evolving landscape and ensure regulatory compliance and product efficacy in the rapidly advancing field of cell and gene therapy, and explore.

Attend this webinar to:

• Expand your understanding of the role of potency assays in measuring biological activity, quality, and stability in CGT
• Gain insights into the FDA’s new draft guidance and how it impacts assay development strategies
• Be able to discern and communicate the unique complexities in selecting, developing, and validating potency assays for CGT, compared to traditional biologics
• Get advice on how to implement a comprehensive potency assurance approach, incorporating multiple product-specific assays throughout the product lifecycle

Audrey Chang

Executive Director, CMC Scientific Advisor at WuXi Advanced Therapies

Dr. Chang has over 28 years of government and industry experience in conducting biological product testing and in managing laboratories. Audrey earned her PhD at the Johns Hopkins University in Biology, and after a post doc at the FDA, joined BioReliance where she held various positions of increasing responsibilities. Prior to joining Wuxi Advanced Therapies, Audrey was VP of QC at Vigene BioSciences which was acquired by Charles River Laboratories. In her current role at ATU, Audrey provides technical solutions and support to clients for both traditional biologics and novel modalities. Audrey has always had a passion for driving innovative products to commercialization and is happy to bring her experience to WuXi Advanced Therapies.

Joe Newcome

Senior Director, Analytical Development at WuXi Advanced Therapies

Joseph “Joe” Newcome is an experienced leader in the cell and gene therapy space, having spent more than 20 years specializing in microbiology, quality control, and rapid testing solutions. Joe is currently a Senior Director, Analytical Development at WuXi Advanced Therapies and focuses on providing innovative solutions for cell and gene therapy manufacturing and testing. With a strong background in GMP-compliant environments and expertise in microbiological testing methods, Joe is dedicated to ensuring high standards of product safety and efficacy, contributing to the success of advanced therapeutic products. In addition to WuXi Advanced Therapies, Joe has held senior roles in Quality Control at Resilience and T-munity.

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SPEAKERS

Audrey Chang

Executive Director, CMC Scientific Advisor at WuXi Advanced Therapies

Joe Newcome

Senior Director, Analytical Development at WuXi Advanced Therapies

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