FUJIFILM Diosynth Biotechnologies (FDB), a world-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting its partners in the biopharmaceutical industry with the development and production of their biologics, vaccines and gene therapies, announced a strategic partnership with OXGENE™, an industry leader in the design and development of gene therapy technologies.
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This partnership will enable FDB to deliver gene therapy products to clients with an approximate 25% lead-time reduction.
FDB has licensed OXGENE's proprietary AAV system for commercial use, to support biotech companies engaged in gene therapy development and manufacture.
The AAV system consists of Helper, Rep/Cap, and Gene of Interest plasmids, used in combination with a clonal suspension a HEK293 cell line. Every aspect of 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, Texas site. Gene of Interest (GOI) plasmid manufacture will be performed in-house using FDB's existing leading 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, which is often associated with delays in initiating process development for novel gene therapies.
With this arrangement, the standard lead-time from the start of process development to the first GMP manufacture could be 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. 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."
Andy Topping, chief scientific officer, FUJIFILM Diosynth Biotechnologies.
Ryan Cawood, chief executive officer at OXGENE said, "OXGENE's ambition is to use our technologies to lead the gene therapy industry's transition to scalable manufacturing solutions, and we are delighted to partner with Fujifilm to do just that."
He continues: "Our AAV production system delivers high titres across multiple serotypes and provides an excellent platform for scalable gene therapy manufacture."