Regenxbio, a clinical-stage biotech that offers gene therapies based on its proprietary NAV Technology Platform, has teamed up with Fujifilm Diosynth Biotechnologies for the manufacture of Regenxbio’s lead product candidates, including RGX-314 and RGX-501, which will support late-stage clinical development and early commercialization. This partnership builds on the foundation of Regenxbio’s internal manufacturing and process development capabilities.

“We are excited to enter into this partnership with Fujifilm, which secures access to capacity and resources that will enable us to produce our lead product candidates at commercial scale using processes developed at Regenxbio,” said Curran Simpson, senior vice president of technical operations, Regenxbio. “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.”

Under the terms of the agreement with Fujifilm, 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 are compliant with global regulatory standards in support of the initiation of worldwide clinical trials for any Regenxbio lead product candidate.

“We look forward to strengthening our relationship with Regenxbio, a leader in the development of innovative gene therapy products providing hope for patients,” said Martin Meeson, president and chief operating officer, Fujifilm Diosynth Biotechnologies, USA. “With our strong track record of execution, and with facilities and systems that are suitable for late stage and commercial production, we are well positioned to support the manufacturing needs of Regenxbio as it continues to move multiple product candidates toward commercialization.”

The agreement with Fujifilm does not limit Regenxbio’s flexibility to invest in its own cGMP manufacturing capabilities as clinical data emerge on lead product candidates. Regenxbio will continue to maintain existing relationships with contract manufacturing organizations for access to additional capacity, if so desired. Regenxbio continues to extend its manufacturing capabilities and intellectual property at its advanced manufacturing and analytics lab in Rockville, MD. Regenxbio has developed the ability to manufacture NAV AAV across multiple platforms from adherent-based processes to the scale-up of suspension-based systems, and now has the internal capability to produce NAV AAV at a scale of up to 200L.