Matrix Approach Enhances Potency Assay Development For ATMPs

Developing potency assays for advanced therapy medicinal products (ATMPs) such as cell and gene therapies is a complex but critical step in ensuring product safety, efficacy, and regulatory compliance. These assays confirm manufacturing consistency and stability, yet challenges like limited batch sizes, short shelf life, and lack of long-term reference materials often complicate the process. A matrix approach, starting with early in vivo proof-of-concept and evolving to optimized in vitro systems, helps address these hurdles by aligning assay design with the product’s mode of action. Key considerations include regulatory requirements, dose-response curve optimization, and implementing quality-by-design principles to minimize variability. Advanced technologies, including automation and robust analytical software, further enhance consistency and throughput.

Explore practical strategies and expert insights to streamline potency assay development for ATMPs.