Fujifilm Diosynth Biotechnologies

Fujifilm Diosynth Biotechnologies, based in Research Triangle Park, North Carolina, USA and Billingham, UK have combined to form the Fujifilm Diosynth Biotechnologies.

Fujifilm Diosynth Biotechnologies offers industry-leading cGMP contract manufacturing services for recombinant proteins, vaccines and monoclonal antibodies. Our combined expertise enables customers to improve the cost-effectiveness and profitability of new therapies by providing fast-track progress into and through their clinical development program, validation and commercialization.

At our sites in Research Triangle Park, NC and Billingham, UK, we offer fully flexible clinical and commercial cGMP facilities for both microbial and mammalian cell culture production. We employ protocol-driven technology transfer processes to bring in projects from customers and seamlessly integrate them into these facilities. We are currently licensed to manufacture four commercial products.

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Locations


United States
Fujifilm Diosynth Biotechnologies RTP
6051 George Watts Hill Drive
Research Triangle Park, NC  27709
United States, North America

GMP Experience
Our facilities have an excellent record of regulatory compliance and have hosted inspections from the FDA, EMEA and other global regulatory authorities.
United Kingdom
Fujifilm Diosynth Biotechnologies Billingham
Billingham,
United Kingdom, Europe

GMP Experience
FDA and MHRA inspected. These facilities have successfully manufactured over 50 protein therapeutics for use in human clinical trials.

Contacts


CMO Locator
CMO Locator

Production Lines

Fujifilm Diosynth Biotechnologies RTP   Merck BioManufacturing Network #1
Location: Research Triangle Park, NC, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L2000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 05OCT10

Send Inquiry about this Production Line
Fujifilm Diosynth Biotechnologies RTP   Merck BioManufacturing Network #2
Location: Research Triangle Park, NC, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L110L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 05OCT10

Send Inquiry about this Production Line
Fujifilm Diosynth Biotechnologies RTP   Merck BioManufacturing Network #3
Location: Research Triangle Park, NC, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L110L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 05OCT10

Send Inquiry about this Production Line
Fujifilm Diosynth Biotechnologies RTP   Merck BioManufacturing Network #4
Location: Research Triangle Park, NC, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L2000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 05OCT10

Send Inquiry about this Production Line
Fujifilm Diosynth Biotechnologies RTP   Merck BioManufacturing Network #5
Location: Research Triangle Park, NC, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L2000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 05OCT10

Send Inquiry about this Production Line
Fujifilm Diosynth Biotechnologies RTP   Merck BioManufacturing Network #6
Location: Research Triangle Park, NC, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L2000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 05OCT10

Send Inquiry about this Production Line
Fujifilm Diosynth Biotechnologies Billingham   MSD 1000
Location: Billingham, United Kingdom
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L1000L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 30SEP10

Send Inquiry about this Production Line
Fujifilm Diosynth Biotechnologies Billingham   MSD 5000
Location: Billingham, United Kingdom
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Scale:  2000L-5000L5000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 30SEP10

Send Inquiry about this Production Line

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