Droplet Digital PCR (ddPCR) for CGT quality control: a podcast with Mark White


In this podcast, Mark White (Associate Director, Biopharma Product Marketing, Bio-Rad Laboratories, CA, USA) discusses the utilization of Droplet Digital PCR (ddPCR) technology for the implementation of quality control during the development of cell and gene therapy products and the importance of quality control in these studies.

Questions

1. What are the greatest risks to patients if human error is introduced into cell and gene therapy quality control?
2. Why is absolute quantification important for quality control and quality assurance in cell and gene therapy development?
3. Can ddPCR technology be operated under GMP standards?
4. How does leveraging ddPCR assays in cell and gene therapy testing impact regulatory applications?
5. How does ddPCR technology compare to other quality control methods, such as qPCR or culture?

 

This podcast is a part of the Bioanalysis Zone Spotlight feature on cell and gene therapy. For more expert opinions on this topic, visit our feature homepage

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