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 robust. Therefore, developers are finding it hard to provide the proof that regulators need to approve products.
This whitepaper explores the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.
Learn more about:
CQA Selection & Assay Development
Testing Strategies & Technologies
Orthogonal Methods for Early Product Characterization
Scale up and Commercial considerations
Learn more about CBM services here, or simply call us: 866-274-4009.
