Fujifilm Diosynth in Gene-Therapy Mfg Pact
Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization of biologic-based drug substances, has partnered with Regenxbio, a Rockville, Maryland-based biotechnology company, to manufacture Regenxbio’s lead gene-therapy product candidates, including RGX-314 and RGX-501.
Under the agreement, Regenxbio gains guaranteed capacity for the supply of adeno-associated virus (AAV) drug substance through its NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene-delivery platform, manufactured under current good manufacturing practice (cGMP) at large scale (up to 2,000 liters) for three years, with the option to extend the agreement for an additional three years.
Regenxbio says it continues to extend its manufacturing capabilities and intellectual property at its manufacturing and analytics lab in Rockville, Maryland. 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 has the internal capability to produce NAV AAV at a scale of up to 200 liters, according to the company.