Tackling the regulatory uncertainty with qPCR and ddPCR in cell and gene therapy development
This webinar will explore recommendations for aligning ddPCR and qPCR development and validation with a regulatory landscape that has yet to be fully defined.
As the rate of cell and gene therapy development increases, droplet digital PCR (ddPCR) and quantitative polymerase chain reaction (qPCR) utilization have increased accordingly. Both can support work across chemistry, manufacturing and control (CMC), preclinical biodistribution and a range of clinical applications (shedding, tracking, adventitious agent detection and the testing of replication competent viruses) for complex cell and gene therapies. While the use of these technologies is common place, the consensus around development and validation under regulatory guidance is less certain. In this webinar, we will focus on better understanding the current regulatory landscape related to the use of ddPCR and qPCR analysis in cell and gene therapy development.
What will you learn?
- An overview of qPCR and ddPCR validation as well as the applications best suited for each one
- Current activities surrounding regulatory guidance in the development of cell and gene therapies
- A deep dive into the recent BMV guidance related to qPCR and ddPCR and its challenges related to cell and gene therapies
- A proposed approach to developing and validating these methods to fit specifically to the development of cell and gene therapies
Speaker
Paul Byrne
Principal Scientist, Cell and Gene Therapy
Labcorp Drug Development (NC, USA)
As Principal Scientist at Labcorp Drug Development, Paul focuses on the evolving field of cell and gene therapies, providing scientific and regulatory leadership and direction on projects throughout the drug development continuum. In addition, he leads an integrated global Labcorp team delivering innovative analytical solutions for clients’ cell and gene therapy programs. In this role, Paul also brings client-specialized expertise in the development and validation of analytical tools and strategies, development of regulatory compliant and molecular biology. Paul has over 20 years of industry experience and can frequently be found speaking at symposia on topics such as analytical development challenges for ATMPs, biodistribution and safety assessment considerations for cell and gene therapies and more.
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