Fujifilm Diosynth Biotechnologies (FDB) has entered a strategic partnership with Oxgene, a developer of gene therapy technologies. FDB has licensed Oxgene’s AAV system for commercial use to support biotech companies with gene therapy development and manufacture. The partnership aims to enable FDB to deliver gene therapy products to clients with an approximate 25% lead-time reduction.

The AAV system consists of Helper, Rep/Cap and Gene of Interest plasmids, used in combination with a clonal suspension a HEK293 cell line. Oxgene’s AAV system, including reconfiguration of the Rep and Cap genes, and clonal cell line selection, has been optimized for maximum AAV yield.

FDB will manufacture and stock a supply of Helper and Rep /Cap plasmids for clients engaged in process development and GMP manufacture of gene therapy programs at FDB’s College Station, TX site. Gene of Interest (GOI) plasmid manufacture will be performed in-house using FDB’s existing microbial capabilities and facilities with cGMP manufacture planned to commence in Q4 2020.

This strategy is expected to reduce the length of the supply chain for FDB’s clients for novel gene therapies. With the start of process development to the first GMP manufacture potentially reduced by 3 to 6 months. The expected timeline reduction is a combination of access to long lead reagents and all plasmids being prepared as research grade allowing process development to begin while GMP GOI production is ongoing.

“Oxgene’s AAV system is superior to off-the-shelf plasmid systems for AAV titers,” said Andy Topping, chief scientific officer at Fujifilm Diosynth Biotechnologies. “This agreement gives Fujifilm Diosynth Biotechnologies “Plasmid to Drug product” capability for AAV systems and allows clients to avoid delays associated with GMP production of plasmids.”