Parallel Line Analysis – How Can we Use it to Establish Relative Potency?
Time: 8:35 am
day: Pre-conf day - Stream A
Details:
This interactive workshop delves into the critical aspect of determining relative potency in gene therapy potency assays. Relative potency assessment involves comparing the potency of a sample against a reference standard, crucial for ensuring the efficacy and safety of gene therapy products. The session aims to evaluate the different methods of analyzing dose-response curves and establishing parallelisms to develop a comprehensive understanding of relative potency determination.
Attend to Discuss:
- Introduction to relative potency: understanding the significance of relative potency in gene therapy and its role in ensuring product efficacy and safety
- Discussing the relevance of analysis models for relative potency
- Clarifying the requirements for demonstrating parallelism between the dose-response of your reference standard and test sample
- Demonstrating the utilization of software and exploring different statistical methodologies to establish comparability between sample and reference standards
- Brainstorming how to generate reproducible dose-response curves to supply a sufficient linear range
- Case studies and practical applications: analyzing sample dose-response curves and discussing example scenarios
