Biomanufacturing facility expansion
Fujifilm Diosynth Biotechnologies (FDB) embarked on an expansion of its flexible biomanufacturing facility at its College Station location in Texas, US, in February 2020.
The facility supports late phase and commercial production of advanced gene therapies. The expansion is intended to increase facility capacity to meet the demand for commercial-ready manufacturing of gene therapy products, with expected completion before the end of 2020.
The project is being implemented with an estimated cost of $35m and is part of the company’s plans to invest approximately JPY13bn ($120m) in the field of gene therapy.
Fujifilm’s flexible biomanufacturing facility is at 3939 Biomedical Way in College Station, Texas.
It covers an area of approximately 80,000ft², situated adjacent to the planned Gene Therapy Innovation Centre.
Expansion of the facility will add cell culture and high throughput manufacturing suites, supporting the production of high volume products, including those developed for the treatment of rare diseases.
The expansion will also involve the addition of multiple bioreactors with capacities of 500l and 2,000l to meet the increasing production demand for gene therapy products. The facility complements the existing development and early phase manufacturing capabilities at the FDB-operated National Centre for Therapeutic Manufacturing in College Station.
National Centre for Therapeutic Manufacturing is involved in process development and good manufacturing practices (GMP) compliant phase one and phase two production of advanced gene therapies (viral, microbial and plasmid).
Advanced biomanufacturing facility uses mobile cleanroom technology for multiproduct and multi-class production of gene therapy products.
The existing gene therapy manufacturing facility focuses on current good manufacturing practice (cGMP) production of clinical, as well as commercial gene product therapeutics. It offers clinical and commercial fill and finish services for gene therapy products.
In January 2019, FDB included aseptic filling of recombinant proteins in its fill and finish service offering at the flexible biomanufacturing facility.
College Station facility is the centre of excellence for the manufacturing of monoclonal antibodies using FDB’s Saturn™ mAb platform.
The current manufacturing facility can accommodate 12 2,000l single-use bioreactors.
The company’s manufacturing sites support client needs over the entire lifecycle of a product. The house fully segregated and self-contained units and feature vaporised hydrogen peroxide (VHP) based cleaning systems with rapid change-over.
CGMP facilities can connect multiple cleanrooms to facilitate upstream, downstream and recovery processes. The facilities also employ single-use technology in systems ranging from cell banks to product vials.
They include process and analytical development and virology sections. Equipped with an extensive quality system, the facilities also released several clinical viral and non-viral vectors.
FDB’s manufacturing facilities are installed with automatic high-speed robotic aseptic fill and finish capabilities.
Fujifilm Diosynth Biotechnologies is a biologics contract development and manufacturing organisation (CDMO) operating in multiple locations including College Station, Texas, Research Triangle Park, North Carolina, US, Billingham and Redcar, UK, and Hillerod, Denmark. The company develops and manufactures recombinant proteins, monoclonal antibodies, vaccines, viral products, medical countermeasures and other large molecules.
FDB offers cell line development services using pAVEway™ microbial and Apollo™ cell line systems. It also provides services such as analytical and process development, clinical and commercial manufacturing.
The firm completed more than 50 process characterisation and validation programmes and delivered over 2,500 cGMP batches.
In November 2019, FDB announced a $55m investment in a Gene Therapy Innovation Center equipped with upstream, downstream and analytical development technologies, expected to begin operations in 2021.
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