REGENXBIO forays into Strategic Partnership with FUJIFILM Diosynth Biotechnologies

Leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Technology Platform, REGENXBIO, forays into strategic agreement with FUJIFILM Diosynth Biotechnologies (FUJIFILM) for manufacturing REGENXBIO’s lead product candidates namely RGX-314 and RGX-501 endorsing late stage clinical development and early commercialization.

Curran Simpson, Senior Vice President of Technical Operations at REGENXBIO said “By aligning our agreement with FUJIFILM to our internal capabilities, we believe we will be well-positioned to meet the NAV AAV production requirements for our current lead product candidates through early commercialization, and to support new, emerging product candidates that may enter our pipeline.”

REGENXBIO gains guaranteed capacity for the supply of NAV AAV drug substance manufactured under current good manufacturing practice (cGMP) at large scale – up to 2,000L – for three years, with the option to extend the agreement for an additional three years. FUJIFILM facilities adhereto global regulatory standards in support of the initiation of worldwide clinical trials for any REGENXBIO lead product candidate.

REGENXBIO persists on extending its manufacturing capabilities and intellectual property at its advanced manufacturing and analytics lab in Rockville, Maryland.