Potency strategy considerations for LNPs containing multiple active ingredients
Time: 4:30 pm
day: Day 2
Details:
- Discussing the requirements of measuring potency for gene therapy products with multiple active ingredients
- Establishing a phase-appropriate approach reflective of the presumed mechanism of action of both drug substance(s) and drug product to maximize product understanding
- Developing an LNP potency matrix linking characterization to product release assays
