The agreement between the Chinese contract development and manufacturing organization (CDMO) STA Pharmaceutical, a WuXi AppTec company, and Antengene, follows China’s 2016 Marketing Authorization Holder (MAH) pilot program.
The MAH program allows drug license holders to use a third party manufacturer instead of building GMP manufacturing capabilities in-house, as was previously required.
Jinling Chen, VP of pharmaceutical development services at STA Pharmaceutical, a WuXi AppTec company, told us the company was the first CDMO to support a drug launch through the MAH program.
As an integrated CDMO, Chen explained that having both its drug substance and drug product research and development (R&D) services in the same facility enables “frictionless” communication as the molecule moves down the pipeline.
“Making the drug substance and drug product in one company in close proximity, working together with a shared quality program saves critical time in the race to reach patients,” said Chen.
"Having the supply chain within one company, with each group is geographic proximity, saves time in shipping, release testing, and method transfers," she added.