Internal manufacturing facility expected to support future clinical and commercial productionFacility will use novel platform suspension cell culture process, which can produce scalable, highly purified NAV Technology-based vectors
“REGENXBIO’s own cGMP production facility is designed to enable us to reach manufacturing scales suitable for future commercial production,” said Curran Simpson, Senior Vice President of Product Development and Chief Technology Officer at REGENXBIO. “The creation of this additional manufacturing capacity using our platform suspension cell culture process will allow us to more efficiently advance our development programs from research stage to the clinic and ultimately to patients, while ensuring manufacturing capacity availability. We expect our manufacturing network to be capable of supporting our internal programs through clinical development and potential commercialization.”
“The manufacturing facility design will enable concurrent production of multiple gene-therapy vectors, and the facility will be co-located with our process development and analytical teams. This integrated approach will allow for more efficient development, manufacture and release of vectors for new indications,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “The new facility will also provide us with scheduling flexibility, allowing for reduced product development timelines at sufficient capacity to meet clinical and projected commercial requirements.”
About REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.
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