Date: 2015-06-11
Type of information: Production agreement
Compound: adeno-associated virus (AAV) gene therapy treatments
Company: RegenXBio (USA - MD) Wuxi Apptec (China)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: manufacturing production
Action mechanism: gene therapy
Disease:
Details: * On June 11, 2015, RegenXBio, a leading biotechnology company in gene therapy, announced that it has entered into an exclusive strategic manufacturing collaboration with WuXi AppTec, a leading technology platform company that provides clients with a broad and integrated portfolio of laboratory and manufacturing services, including expertise in characterization and analysis of biologics. Through this collaboration, RegenXBio plans to establish efficient, scalable manufacturing processes within current Good Manufacturing Practice (cGMP) guidelines for the production of 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 square-foot cGMP facility currently under construction in Philadelphia. This facility is specially 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.
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