No critical findings for first-of-its kind inspection of China-based cGMP bio-manufacturing facility.
WuXI Biologics and partner TaiMed biologics recently disclosed the FDA had completed its Pre-License Inspection (PLI) of WuXi’s cGMP biologics manufacturing operations in China, and that for the production of HIV therapy TMB-355 (ibalizumab), the facilities garnered no critical findings.
WuXi said the FDA inspection was the first of its kind in China. Consisting of a 5-inspector, 13-day program the inspection covered both drug product and drug substance processing facilities located in its home country Wuxi, China. WuXi said it expects to quickly conclude all follow-up action within 90 days and not impact the Biologics License Application (BLA) review timeline.
If TMB-355 is approved, the inspected facilities will be the first cGMP biologics manufacturing operations to get a greenlight for the commercial production of biopharmaceuticals in the country. “Marking yet another milestone that WuXi Biologics has set in China,” said the announcement, “This pending US FDA approval continues to reinforce the strong commitment to quality WuXi Biologics has made to its global client base.”
According to WuXi, ibalizumab is a mAb being developed to treat Multiple Drug Resistant Human Immunodeficiency Virus-1 (MDR HIV-1) infection in humans. As opposed to alternative antiretroviral therapies, ibalizumab binds primarily to second extracellular domain of the CD4+ T-cell receptor sites. Because the receptors are located away from major histocompatibility complex II molecule binding sites, WuXI said it has the potential to “prevent HIV from infecting CD4+ immune cells while preserving normal immunological function.”
An FDA-designated Breakthrough Therapy, ibalizumab is currently under review following the acceptance of the company’s BLA, submitted in June 2017 and submission of its Prescription Drug User Fee (PADUFA), set for January 2018.