CASE STUDY · OPHTHALMOLOGY
GeneVector: analytical package for a dual-plasmid AAV, IND cleared
Challenge
JWK001 for nAMD was the first AAV candidate made with a dual-plasmid system, so there were few precedents for its methods, release testing and stability studies.
Our work
Analytical method development and validation, release testing, stability testing and characterization for the CMC package.
Outcome
China's NMPA approved the IND for JWK001 Injection on Feb 22, 2024.




