The FDA has approved the first batch of ibalizumab (TMB-355) drug substance and sterile drug product manufactured at WuXi’s biologics facilities for ongoing treatment of patients in an expanded access program under an investigator IND.  Ibalizumab, which is being developed by TaiMed Biologics, is a humanized monoclonal antibody and a member of an emerging class of HIV therapies known as viral-entry inhibitors.

The drug substance of ibalizumab was manufactured at WuXi’s cell culture manufacturing facility in Wuxi city, 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.  The automated filling line can accommodate 2-50mL liquid and lyophilized vial products for global clinical trials and product launch.

This is the first reported FDA approval of a sterile biologics product manufactured in China for use under a U.S. IND.  It marks an important milestone in WuXi’s initiative to expedite global development of innovative biologics through creation of an integrated biologics discovery, development, manufacturing and testing service platform.

 

Related links:

WuXi PharmaTech Receives Honorable Mention at 2014 ISPE Facility of the Year Awards
WuXi PharmaTech Facilities for Late – and Commercial-Stage Analytical and Stability Testing and Clinical-Trial Materials Manufacturing Pass FDA Audit
First Chinese-made biologics slated for human trials in the West