We are one of the world’s leading suppliers of contract process development and manufacturing services for the biopharmaceutical industry. Created in April 2011, Fujifilm Diosynth Biotechnologies has more than 900 employees, operating from two sites in Billingham, UK, and the Research Triangle Park in North Carolina, US.
We have more than 15 years' experience of working with an excess of 180 complex proteins. Both our UK and US sites have been successfully FDA-inspected for the manufacture of commercial products. This in turn, demonstrates our established track record in navigating the critical path through validation and regulatory approval.
Over the last year, we have announced additional mammalian cell culture capacity at both our RTP site (commissioned early 2012), as well as a new cGMP mammalian cell culture facility at our Billingham, UK site (commissioned Q3 2013).
A 'one-stop-shop' is available for antibody drug conjugate (ADC) development through our alliance with Piramal Healthcare. The combined ADC development between Fujifilm and Piramal ensures rapid conjugation demonstration and route to market.
Biologics process development
As a full-service contract manufacturer, Fujifilm Diosynth Biotechnologies offers a vast range of process development capabilities to meet customers' needs at every stage of the product lifecycle.
Our experience guarantees process development is applied correctly, depending on the development needs of the customers' products at various clinical stages. Fujifilm Diosynth Biotechnologies provides:
- An extensive range of constructs and expression options, including development of customers' existing system, as well as creating one de novo from our family of microbial therapeutic protein production systems, e.g. our pAVEway™ system
- Microbial capability in the development laboratories, including multiple 5l, 15l and 140l fermenters
- Mammalian cell line development capability
- Mammalian capability in the development laboratories, such as multiple 2l, 5l, 10l, 15l, 20l and 110l bioreactors, wave 20/50, and 2 x 200l Xcellerex systems
- 100l scale pre-cGMP pilot plant for process demonstration and supply of pre-clinical material
Biologics cGMP manufacturing
Both our sites in Billingham and North Carolina, offer a variety of mammalian and microbial cGMP manufacturing skills. We employ protocol-driven technology transfer processes to bring in projects from customers, and seamlessly integrate them into these facilities. Fujifilm Diosynth Biotechnologies' facilities have received successful regulatory inspections from all key regulatory agencies.
- Various scales for rapid cGMP manufacture of material for Phase I-III clinical supply, process validation and commercial supply from 100l to 5,000l
- Flexible plant configurations including disposables technology and refold volumes of up to 10,000l
- 2x110l and 1x2,000l train (20l,145l, 650l) for cGMP manufacture of material for Phase I-III clinical supply, process validation and commercial supply
- 1x1000l single-use bioreactor at RTP site; 1x200l and 1x1000L single-use bioreactor at Billingham site; 1x2000l single-use bioreactor planned for 2014 at Billingham site
Biologics manufacturing support services
The following additional services are offered to reduce complexity and risk of multiple suppliers:
- cGMP cell banking facilities for production of master and working cell banks
- Buffer screening studies to support downstream process development
- Development of stable product formulations
- Full range of in-house analytical methods
- Full range of stability testing capabilities for drug substance and drug product
Quality and regulatory support for biopharmaceutical development and manufacturing
- To make sure our customers' products meet international regulatory requirements, we supply all the necessary quality and regulatory support through an independent quality unit
- We provide regulatory support for IND/CTA submission, DMF and CMC, as required
- We conduct quality control analysis on the release of raw materials, environmental and water in-process/final, sample retention
- We offer ownership and use of qualified or validated methods
- Fujifilm Diosynth Biotechnologies promises quality agreement, followed by routine interactions with customers, throughout the programme