Fujifilm Diosynth Biotechnologies


Contract development and manufacturing organization (CDMO) providing end-to-end biologics services from cell line and strain development through process development, cGMP clinical and commercial manufacturing, analytical development and regulatory/CMC support. Operations include mammalian, microbial and viral/vaccine platforms, single-use bioprocessing at scales up to 2000 L, and application of high-throughput and automation technologies for process development and scale-up.

Industries

biotechnology
health-care
manufacturing

Nr. of Employees

Very Large (1000+)

Fujifilm Diosynth Biotechnologies

Morrisville, North Carolina, United States, North America


Patents

Protein purification in high salt solutions such as cell culture broth

US-7998705-B2

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Products

CHO-based mammalian expression platform

An integrated mammalian expression platform combining a CHO-derived host cell line, expression vector design, screening and media/feed optimization to deliver high-producing, manufacturing-ready clones.

Advanced microbial protein expression platform

Microbial expression system and process development capability for high-yield recombinant protein production with DoE and high-throughput fermentation screening.


Services

Integrated development and manufacturing services from pre-clinical material through clinical and commercial supply for biologics.

Host selection, expression vector integration, high-throughput screening and generation of manufacturing-ready clonal cell lines for mammalian and microbial systems.

Upstream and downstream process design, DoE, scale-down modeling and transfer to clinical and commercial manufacturing.

cGMP manufacturing for drug substance and drug product across mammalian, microbial and viral platforms including single-use and stainless steel options.

Production and supply of cGMP mammalian cell banks to support development and manufacturing programmes.

Analytical method development, characterization and process qualification including mass spectrometric analysis for complex conjugates.

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Expertise Areas

  • Contract development and manufacturing (CDMO)
  • Mammalian cell culture development and manufacturing
  • Microbial fermentation and protein expression
  • Vaccine and viral/viral-vector manufacturing
  • Show More (5)

Key Technologies

  • Single-use bioreactors (scales up to 2000 L)
  • CHO-based mammalian expression systems
  • Automated high-throughput mini-bioreactor systems
  • Robotic chromatography and automated purification platforms
  • Show More (4)

News & Updates

Acquisition of the Merck BioManufacturing Network assets, adding facilities in Research Triangle Park (NC, USA) and Billingham (UK) to the company's biologics manufacturing footprint.

Completed acquisition of a 49% interest in Kalon Biotherapeutics to expand vaccine and viral manufacturing capabilities and high-containment operations.

Commissioned a new mammalian cGMP cell banking facility to support development and manufacturing programmes at Billingham and RTP sites.

Expanded cell culture manufacturing capacity with installation of 2000 L single-use bioreactors at sites in the UK and USA to support scale-up and commercial production.

Introduced a mammalian expression platform combining host cell line, vector design and optimized media/feed to produce manufacturing-ready clones and high initial titers.

Received renewal of the UK Manufacturer’s Licence authorizing commercial manufacturing at the Billingham site with zero critical or major observations.

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