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Fujifilm Diosynth Biotechnologies

Biopharmaceutical Process Development and Manufacturing Services

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Fujifilm Diosynth Biotechnologies

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.

Fujifilm

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.

Microbial:

  • 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

Mammalian:

  • 2x110l and 1×2,000l 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

Contact details:
Fujifilm Diosynth Biotechnologies

Belasis Avenue
Billingham
TS23 1LH
United Kingdom
Phone: +44 1642 363511
Email: enquiries@fujifilmdb.com
Website: www.fujifilmdiosynth.com

About Our Products and Services

We offer a wide range of products, including:

pAVEway™ Advanced Protein Expression - a novel platform of innovative vectors, selected host strains and fermentation methods, leading to industry leading titresProcess Development & scale up using a wide range of constructs and expression optionsDevelopment, scale up and validation of PEGylation unit operationscGMP manufacturing - a range of scales for both mammalian and microbialFull range…

Analytical Development

Our in-house analytical development team is expert in development, invention and verification of methods and assays in support of early stage programmes.

The analytical development group forms an integral part of the programme, ensuring that all process parameters affecting product quality are identified and fully understood. This enables the successful operation of quality by design in routine cGMP manufacture.Assays will typically be developed that detect changes in:The target protein and related speciesProcess impuritiesProtein potencyAfter development, the assays…

One-Stop-Shop for Antibody Drug Conjugation

We can also offer a 'one-stop-shop' for antibody drug conjugates through our alliance with Piramal Healthcare. Through our rapid delivery of ADC drug substance, simplified supply chain and aligned mAb and ADC programmes the benefits include:

Early transfer of material from Fujifilm to Piramal - rapid demonstration of conjugationTransfer of analytical methods from Fujifilm to PiramalIntegrated programme management teams

Process Characterisation

Through this stage we develop and refine your process.

We offer:Process characterisation through design of experiments (DOE) statistical analysisIn-house process and method validation through our analytical development and quality control departmentsValidation master plan creationQuality by design (QbD) 

Process Validation

We offer process validation as an integral part of manufacturing as we know it is the key to your programme's success.

Process validation includes:Determination of key process parameters and their operating ranges appropriate for the facilities on which the process will be runScale-down modeling of limits of re-use (for example, columns) and other formal frameworks to assess risk and aid good scientific judgmentExtractables studiesGood documentation to trace back and support developed rationales

Upstream and Downstream Process Development

Early phase process design as well as optimisation involves the expertise of our cell culture and microbial fermentation specialists.

We have:Experienced R&D staff dedicated to development and support of early phase projectsFormulation development and stability expertiseInvestigational new drug (IND) submission support services, with experience in submissions for over 100 moleculesRapid optimisation enabled by design of experiments (DOE)Development and scale up of refold for inclusion bodiesDevelopment and scale up of PEGylation using various technologies For our…
Quick Contact Fujifilm Diosynth Biotechnologies
Quick Contact Fujifilm Diosynth Biotechnologies


Quick Contact Fujifilm Diosynth Biotechnologies
Quick Contact Fujifilm Diosynth Biotechnologies
Quick Contact Fujifilm Diosynth Biotechnologies


Contact Fujifilm Diosynth Biotechnologies

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Quick Contact Fujifilm Diosynth Biotechnologies