YANTAI, China and SAN DIEGO, Jan. 15, 2019 /PRNewswire-PRWeb/ -- MabPlex International
MabPlex was contracted to develop and manufacture the product from cell line development to IND filing in both the United States and China.
MabPlex provided fully integrated services from cell line development to final drug product including a complete CMC package in support of the United States IND submission. Additionally, the IND filing for the Chinese NMPA will be completed in the near future.
"This approval adds another milestone to our global repertoire of international IND submissions after the successful approval of an Australian IND last year," said Jianmin Fang, Ph.D, Chairman and Chief Executive Officer of MabPlex International, Ltd.
"MabPlex's high standards in development and cGMP quality management have been recognized by US, Australian and Chinese regulators demonstrating the strength of our global CDMO services," Fang added.
About MabPlex MabPlex, a leading and fully integrated Contract Development and Manufacturing Organization (CDMO), offers an advanced biologics platform and comprehensive and integrated solutions to global biopharmaceutical developers. Founded in 2013, MabPlex currently has two sites in China (Yantai and Shanghai) and one site in the United States (San Diego, CA) offering high quality services from biologics drug development to commercial manufacturing. With our state-of-the-art facilities and exemplary biologics development and manufacturing experience, MabPlex commits to being a valuable partner for our clients around the globe.
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