(CASE STUDY) Implementing a Tailored Potency Assay Strategy to Ensure GMP Compliance & Overcome Regulatory Concerns
Time: 11:00 am
day: Pre-Conference Focus Day
Details:
- 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
