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The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.
REGENXBIO entered into an exclusive strategic manufacturing collaboration with WuXi AppTec, the companies announced June 11, 2015. Through this collaboration, REGENXBIO plans to establish efficient, scalable cGMP manufacturing processes for adeno-associated virus (AAV) gene therapy treatments incorporating REGENXBIO’s NAV Technology.
Under the terms of the agreement, REGENXBIO and WuXi will establish a proprietary production process for NAV Technology treatments designed to enable the rapid advancement of REGENXBIO’s and licensees’ therapeutic programs from clinical trials through commercialization in WuXi’s 145,000 ft2 cGMP facility that is currently under construction in Philadelphia. This facility is designed to accommodate gene therapy products that contain viral vectors such as REGENXBIO’s NAV Technology platform. The partnership will combine REGENXBIO’s expertise in AAV process development with WuXi’s commercial manufacturing proficiency and established infrastructure. As part of the collaboration, REGENXBIO has already initiated with WuXi the production of material to be used in planned clinical trials.
“The proximity of WuXi’s new facility to both REGENXBIO’s corporate headquarters in Rockville, Maryland and Dr. Jim Wilson’s lab at the University of Pennsylvania is expected to help facilitate a successful collaboration," said Ken Mills, president and CEO of REGENXBIO. "We look forward to working with WuXi and view this partnership as an important step toward getting meaningful gene therapy treatments to patients.”