ddPCR-Based Analytics: Applications And Key Parameters In Developing ddPCR-Based Analytical Methods For Cell And Gene Therapies

By Anne Bickel, Senior Manager Process Development & Innovation, and Karin Abitorabi, Head of Process Development and Innovation, Minaris Regenerative Medicine GmbH (Germany)

Cell and gene therapies are revolutionizing the field of medicine and enabling treatment for diseases with previously unmet medical needs. However, the industry is rapidly evolving to leverage innovative technologies and meet regulatory guidelines. Utilizing a robust, dependable process to evaluate product safety and efficacy is crucial as you aim to increase operational efficiency and deliver therapies to patients with ease.

Digital droplet PCR (ddPCR) is becoming an increasingly important tool in the development and quality control of cell and gene therapies. While the well-established and widely used qPCR method provides absolute quantification only when using standards, the partitioning step within ddPCR allows for direct absolute quantification, eliminating the need for standard curves. The digital output of ddPCR also enables simplified data analysis as well as data comparison across different laboratories and studies.

Employing ddPCR can help to optimize cell and gene therapy manufacturing processes by providing reliable detection of vector copy numbers, ensuring that parameter changes during process development are correctly evaluated. Explore the potential of ddPCR to increase the safety and efficacy of advanced therapeutics and optimize process protocols.