Residual DNA testing in viral vector manufacture: exploring the challenges and solutions
May 19, 2022
Ilaria Scarfone and Mike Brewer
In this episode Ilaria Scarfone Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific speaks to Mike Brewer, Director and Global Principal Consultant, BioProduction Division, Thermo Fisher Scientific about the challenges for residual DNA testing in viral vector manufacture.
To read this interview and access lots more content, visit the Cell and Gene Therapy Insights website.
Q1. Mike, to begin, could you give a brief introduction and background on the residual DNA testing regulatory requirements in general, and why gene therapy products present some particular challenges?
Q2. Before we analyze each of these particular concerns, let’s discuss some of the challenges in the development and validation of residual DNA analytical assays in general, and in particular for gene therapy.
Q3. Looking at validation and qualification, how does the Thermo Fisher Scientific development validation study help ensure the quality of the kits, and how does this differ from the validation of the method for regulatory approval?
Q5. Do you have any suggestions on how to address copy number versus mass concerns?
Q4, Focusing on gene therapy, and residual DNA testing in particular, let’s address a couple of specific questions I am often asked by customers. How do we help simplify the process of measuring vector DNA, and how do we address the challenges of fragme