Adeno-associated virus (AAV) has emerged as the primary vector for in vivo gene therapy applications. AAV samples are measured and dosed based on DNA concentration, traditionally assessed through conventional quantitative PCR (qPCR). However, digital PCR methods, which allow for absolute quantification of target sequences and eliminate the need for a standard curve, are replacing qPCR methods due to their improved precision. An accurate AAV titration method is crucial throughout the entire drug development process, including preclinical studies, process development, and clinical dosing.
 
This webinar will cover the following topics:

  • Highlights of method development for establishing well-controlled AAV titration methods
  • Comparison of multiple digital PCR platforms for AAV titration
  • Strategies for transitioning from legacy qPCR methods to enhanced digital PCR platforms
About the speaker
Stuart Nelson, Technical Lead of Analytical Control Strategy
Eli Lilly and Company
Stuart Nelson is a Technical Lead of Analytical Control Strategy at Eli Lilly. Stuart has over a decade of industry experience in drug development for several biologic modalities. He joined Prevail Therapeutics in 2018 (acquired by Lilly in 2021), holding increasing levels of responsibility over the last 4+ years. His most recent contributions were as part of the CMC and analytical development teams, helping advance multiple gene therapy programs from pre-IND to clinical dosing.
Date of recording:20 June 2023
Duration:60 minutes
Categories
Webinar
Pharma / Biopharma
Genetherapy
dPCR
Digital PCR