Featured CMO:   Cytovance Biologics, Inc.

Cytovance® Biologics offers significant value to biopharmaceutical development programs by providing full service manufacturing solutions to advance recombinant protein, antibody and cell-based therapeutic products rapidly and cost-effectively from the bench, through clinical development and to commercial launch.  In addition to its cGMP manufacturing services, Cytovance offers Cell Line Development, Process Development, Cell Banking, Microbial Manufacturing and Fill/Finish.

Manufacturing occurs in our custom-designed facility that supports multi-product cGMP production of therapeutic proteins from mammalian cell culture and microbial systems and meets the latest international regulatory standards, including current Good Manufacturing Practices (cGMP), the latest European regulations and International Standard ISO 14644 "Cleanrooms and Associated Environments".  The design was reviewed in a Type C meeting with the US Food and Drug Administration prior to construction.

This 44,000 sq. ft. facility features primary production in cell culture suites containing bioreactors at 100L (w/v), 500L (w/v) and 1,000L (w/v) scale under ISO 7 classification.  Recovery and purification occurs in adjacent independent ISO 7 suites.  The facility features an ISO 6 classification suite used for small scale cGMP liquid fill and finish operations.  Microbial fermentation is at the 100L scale.

Cytovance operates an adjacent 6,000 sq. ft. cGMP clean room facility with cell banking and PD operations and two additional suites for pilot production or custom processes.  QC labs are located in an adjacent third facility.


Click here to begin the discussion with a Cytovance representative.

Locations


United States
Cytovance Biologics, PD, QC & Main Offices
800 Research Parkway
Suite 200
Oklahoma City, OK
United States, North America
United States
Cytovance Biologics Manufacturing Facility
885 Research Parkway
Oklahoma City, OK
United States, North America

Contacts


Cathy Smith
Director, West Coast Sales & Business Development
Edwin Beale
Director, Mid-Atlantic Business Development
Valerie McDonnell
VP of Sales and Business Development

Production Lines

Cytovance Biologics Manufacturing Facility   cGMP Mammalian #1
Location: Oklahoma City, OK, United States
Main Details
Drug Substance (API)Drug Substance (API) Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Checked Analytical Services
Checked Cell Banking
Checked Cell Line Development
Checked Preclinical Manufacturing
Checked Process Development
Unchecked Viral Manufacturing
Availability: Available

Last Update: 21DEC11

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Cytovance Biologics Manufacturing Facility   cGMP Mammalian #2
Location: Oklahoma City, OK, United States
Main Details
Drug Substance (API)Drug Substance (API) Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L500L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Checked Analytical Services
Checked Cell Banking
Checked Cell Line Development
Checked Preclinical Manufacturing
Checked Process Development
Unchecked Viral Manufacturing
Availability: Available

Last Update: 21DEC11

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Cytovance Biologics Manufacturing Facility   100L Fermentation
Location: Oklahoma City, OK, United States
Main Details
Drug Substance (API)Drug Substance (API) Platform:  MicrobialMicrobial
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Checked Analytical Services
Checked Cell Banking
Checked Cell Line Development
Checked Preclinical Manufacturing
Checked Process Development
Unchecked Viral Manufacturing
Availability: Available

Last Update: 21DEC11

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Cytovance Biologics Manufacturing Facility   Fill/Finish
Location: Oklahoma City, OK, United States
Main Details
Drug Product (Fill/Finish)Drug Product (Fill/Finish) Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Checked Analytical Services
Checked Formulation Development
Checked Preclinical Manufacturing
Checked Stability Studies
Unchecked Prefilled Syringes
Unchecked Viral Manufacturing
Availability: Available

Last Update: 21DEC11

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Cytovance Biologics Manufacturing Facility   cGMP Mammalian # 3
Location: Oklahoma City, OK, United States
Main Details
Drug Substance (API)Drug Substance (API) Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L1000L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Checked Analytical Services
Checked Cell Banking
Checked Cell Line Development
Checked Preclinical Manufacturing
Checked Process Development
Unchecked Viral Manufacturing
Availability: Available

Last Update: 21DEC11

Send Inquiry about this Production Line
Cytovance Biologics Manufacturing Facility   Mammalian (SUB)
Location: Oklahoma City, OK, United States
Main Details
Drug Substance (API)Drug Substance (API) Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L200L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Checked Analytical Services
Checked Cell Banking
Checked Cell Line Development
Checked Preclinical Manufacturing
Checked Process Development
Unchecked Viral Manufacturing
Availability: Contact CMO

Last Update: 21DEC11

Send Inquiry about this Production Line
Cytovance Biologics, PD, QC & Main Offices   Mammalian (SUB)
Location: Oklahoma City, OK, United States
Main Details
Drug Substance (API)Drug Substance (API) Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L50L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Additional Services
Checked Analytical Services
Checked Cell Banking
Checked Cell Line Development
Checked Preclinical Manufacturing
Checked Process Development
Unchecked Viral Manufacturing
Availability: Contact CMO

Last Update: 21DEC11

Send Inquiry about this Production Line

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