FUJIFILM Diosynth Biotechnologies Enters Strategic Partnership With OXGENE™ To Address Supply Bottlenecks In Gene Therapy Development And Manufacturing
Capabilities expand to supplying plasmids for triple transfections
BILLINGHAM, United Kingdom, April 23, 2020 /PRNewswire/ -- 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. 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 optimised 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," 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."
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."
About Fujifilm
FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com
FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2019, the company had global revenues of $22 billion, at an exchange rate of 111 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.
About OXGENE
OXGENE™ combines precision engineering and breakthrough science with advanced robotics and bioinformatics to accelerate the rational design, discovery and manufacture of cell and gene therapies across three core areas: gene therapy, gene editing and antibody therapeutics.
Gene therapy: We're transforming the vision of truly scalable gene therapies into a reality; progressing our industry leading transient gene therapy systems towards alternative technologies for scalable, stable manufacturing solutions.
Gene editing: We have automated gene editing to deliver CRISPR engineered cell lines at unparalleled speed, scale and quality and generate complex disease models in mammalian cells.
Antibody therapeutics: We're employing a novel proprietary mammalian display technology to discover antibodies against previously intractable membrane proteins.
OXGENE™ works at the edge of impossible in mammalian cell engineering. Our scientific expertise and technology solutions address industry bottlenecks. For more information, please visit www.oxgene.com
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