WuXi PharmaTech and TaiMed Biologics today announced that the FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product manufactured at WuXi's biologics facilities for ongoing treatment of patients under investigator-sponsored IND's.
This is the first reported FDA approval of a sterile biologics product manufactured in China for use under a U.S. IND, which marks an important milestone of WuXi's investment to expedite global development of innovative biologics.
Ibalizumab is a humanized monoclonal antibody and a member of an emerging class of HIV therapies known as viral-entry inhibitors. It is being developed by TaiMed Biologics for the treatment of HIV/AIDS infection.
The drug substance of ibalizumab was manufactured at WuXi's cell culture manufacturing facility, which recently received an honorable mention facility-of-the-year award by ISPE. The ibalizumab drug product batch approved by the FDA was manufactured at the newly completed state-of-the-art cGMP parenteral manufacturing facility located within the same campus as the cell culture facility at Wuxi city. The automated filling line can accommodate 2-50mL liquid and lyophilized vial products for global clinical trials and product launch.
"We congratulate TaiMed for progressing ibalizumab further in development and bringing this important drug one step closer to approval," said Dr. Ge Li, Chairman and Chief Executive Officer of WuXi PharmaTech. "WuXi is proud to serve as a gateway for developing novel biologics in China. Our integrated biologics discovery, development, manufacturing and testing service platform provides our customers with a seamless solution to bring their biologics products to the market globally and in China."
"TaiMed is pleased with the speed and excellent execution of this project to ensure the success of this important drug. We look forward to the next phase of collaboration with WuXi to successfully bring the drug to marketing approval," said Dr. James Chang, Chief Executive Officer of TaiMed Biologics.