The FDA has been increasingly calling for manufacturers to develop more consistent ways to measure product quality. However, mechanisms of action of cell and gene therapies are poorly understood, and assay design is not rubust, therefore, developers are finding it hard to provide the proof that regulators need to approve products.
Analytical Testing & Characterization
Strategies for Advanced Therapies
Download this free whitepaper to learn about:
- CQA Selection & Assay Development
- Testing Strategies & Technologies
- Orthogonal Methods for Early Product Characterization
- Scale up and Commercial considerations