Top tips from industry leaders on optimizing your viral vector process intensification strategy

Cell & Gene Therapy Insights 2021


Published: 25 March 2021
Expert Insight

Mike Delahaye

Head of Viral Vector Industrialisation, Cell and Gene Therapy Catapult

“If we think about accelerating process development, the emphasis needs to be on the development and qualification of rapid characterization tools, both from a product and impurity perspective.”

Michael White

Senior Scientist, ‎Affinia Therapeutics

“Incorporating these process models that you build out into early process development, for inter-local screening conditions, will help to predict success or failure for various different AAV variants, and help to differentiate your base process.”

Franz Gerner

Vice President, Technical Operations, Sio Gene Therapies

“For the analytical part, I think more robust and quantitative assays will be in our toolbox in the future.”

Jessica Tate

Head of Science & Technology Development, Viral Vector Services, Thermo Fisher Scientific

“Two big culprits force us to have a large facility or require the use of many CDMOs, and they are productivity versus demand.”

Jim Warren

Vice President, Pharmaceutical Development, Ultragenyx Pharmaceutical Inc.

“Making comparisons of apples to apples is really important. The use of historical data for comparability is somewhat risky, and it is very often prudent to use head-tohead testing, particularly for the high variability assays, in order to confirm that comparability.”

Susan D'Costa

Senior Director, Technical Program Design, Viral Vector Services, Thermo Fisher Scientific

“The fact that you can encapsulate other DNA and protein impurities within that capsid shell is really what increases the amount of impurities that come through the process.”

See our panel of experts' top three tips on optimizing your viral vector process intensification strategy:

1. How to approach the challenge of process intensification to help industrialize your viral vector production from the accelerating bioprocessing side.

2. How to demonstrate comparability between processes when transitioning from early phase to late phase, especially when there are significant differences in processes and analytics.

3. The critical next steps in vector bioprocess analytical technology innovation.