Analytical Assays with qPCR and dPCR in CGT Development, Characterization, and Regulatory Compliance

Explore the critical role of quantitative PCR (qPCR) and digital PCR (dPCR) technologies in cell and gene therapy development through this 42-minute webinar presented by Dr. Lee Landeen from Angiocrine Bioscience. Gain insights into regulatory requirements for cell and gene therapy products, understanding how these analytical assays ensure safety and efficacy standards are met before patient use. Learn about the regulatory landscape governing cell and gene therapies, discover how qPCR and dPCR serve as essential analytical tools for product characterization and compliance, and examine successful case studies that can guide future therapy development. The presentation provides a high-level overview of regulatory standards and guidelines while highlighting sources of information to support development processes. Dr. Landeen brings over 30 years of biotechnology experience across tissue engineering, regenerative medicine, and cell-based therapies, offering practical perspectives from roles spanning product development, preclinical research, process development, analytical development, quality control, manufacturing support, and CMC. Participants can earn PACE credits by completing the viewing requirements and accessing the continuing education portal through Labroots' Cell & Gene Therapy 2025 virtual event platform.