Considerations for analytical methods used for DSP characterisation
Time: 9:50 am
day: Day Two
Details:
- Establishing Robust and Reproducible Analytical Methods: Ensuring accuracy and consistency in characterizing downstream processing (DSP) steps to meet regulatory and quality requirements.
- Key Analytical Techniques for Purity, Potency, and Safety Assessment: Evaluating critical quality attributes (CQAs) of gene therapy products, including residual impurities, vector integrity, and biological activity.
- Overcoming Challenges in Method Development and Validation: Addressing sensitivity, scalability, and regulatory expectations to optimize DSP characterization for clinical and commercial applications.
