POTENCY ASSAY FOCUS DAY
8:30 am Developing Appropriate Reference Standard Materials for Potency Assays to Enhance Batch Comparability
Synopsis
2h Interactive Deep-Dive
- Discussing strategies for developing, characterising, and qualifying in-house primary reference material and working reference materials
- Qualifying methods for ensuring batch-batch comparability and titre consistency.
- Establishing reference standard materials for both AAV serotypes and lentiviruses to enhance lab to lab reproducibility
- Brainstorming the challenges of bridging new reference standards during potency assay development
10:30 am Morning Break & Networking
11:00 am (CASE STUDY) Implementing a Tailored Potency Assay Strategy to Ensure GMP Compliance & Overcome Regulatory Concerns
Synopsis
- Discussing the optimisation of cell lines to reduce background protein expression and ensure GMP compliance
- Building novel cell models to improve potency assay efficiency and reduce costs
- Divulging methods to ensure a potency strategy remains robust through to endpoint analysis
- Implementing appropriate statistical tests for batch-batch comparability
12:00 pm Lunch
1:00 pm PANEL DISCUSSION: Discussing Strategies to Correlate the Outputs of a Potency Matrix Approach to Manage Regulatory Expectations
Synopsis
- Exploring the potency matrix and understanding the relevance of the constituent assays
- Aligning measures of infectivity, mRNA, protein, and biological activity to generate robust potency assay data
- Understanding correction factors and correlation coalitions in potency assay read-outs
- Upper and lower limits: discussing regulatory perspectives on infectivity titres
2:00 pm Assay Optimisation Throughout the Early to Late-Stage Transition to Facilitate Phase-Appropriate Potency Analysis
Synopsis
- Using potency matrices throughout early and late-stage potency assay design
- Understanding how to use MoAs to select potency assay methods during early clinical development
- Formulating robust validation protocols during potency assay upscaling
3:00 pm Interactive session: How Do we Best Measure Potency? Discussing the Implementation of Appropriate Statistical Tests & Success Criteria To Meet Regulatory Expectations
Synopsis
- Determining appropriate analytical methods for measuring product expression
- Implementing model-specific system suitable criteria to assess potency
- Understanding how to use appropriate statistical tests (line vs sigmoid analysis) when designing a potency strategy to competently assess comparability