Summary
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To address these challenges, the FDA issued a draft guidance in December 2023, titled “Potency Assurance for Cellular and Gene Therapy Products,” which marks a shift from a single potency test approach to a comprehensive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.
Watch this video recording of our Cell & Gene Therapy Insights Live 30 webinar and panel discussion held on December 10th, 2024
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Gain insights into the FDA’s new draft guidance and how it impacts assay development strategies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