Adapting analytics and quality control to ensure adequate safety, purity, and potency of final products
15 Apr 2025
C & G Manufacturing
- What are the most important critical quality attributes (CQAs) for gene therapy products?
- Should the potency assays include both expression and functional aspects? Why?
- What is the role of infectivity assay in the quality control of gene therapy products? Could it ever be made more robust?
- Does structure-function studies have a role to play for product characterization for gene therapy products?
- What are the considerations in proposing limits of DNA impurities in gene therapy products?
