Cognate BioServices

Cognate BioServices is a leading contract development and manufacturing organization specialized in cell and cell-mediated gene therapies. We pride ourselves in the level of quality and experience we bring to the table. We are unique in a number of ways, including but not limited to:

  • Our late stage experience in personalized cellular therapies;
  • A wide range of operating, technical and leadership experience spanning cellular immunotherapy and regenerative medicine;
  • A commitment to commercial readiness and PAI inspection for personalized and off-the-shelf cellular immunotherapy products including but not limited to, Car-t, TCR, TIL, MIL, DC, and NK cells.

In our operating history we’ve successfully manufactured and delivered products to and from the US, EU and Asia, and we’ve handled all aspects of the supply chain, manufacturing, storage, shipping and clinical trial logistics, and regulatory support for protocol and IND development for complex products involving multiple drug substance intermediates all the way to minimally manipulated primary cells.

Come visit our website and learn more

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Locations


United States
Commercial Manufacturing cGMP Facility
4600 East Shelby Drive
Suite 108
Memphis, TN  38118
United States, North America

GMP Experience
Mid to late stage clinical and commercial readiness activities, US and EU inspection. EU GMP certificate held.
United States
Development and Analytical Services
2600 Cabover Drive
Suite F&G
Hanover, MD  21076
United States, North America

Contacts


Scott Broughton
VP Sales and Marketing
J. Kelly Ganjei
Chief Executive Officer
Mike Stella
Chief Business Officer
Shari Pire
Chief Legal Officer

Production Lines

Commercial Manufacturing cGMP Facility   Multiple US and EU Production Suites
Location: Memphis, TN, United States
Main Details
Specialization:  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 IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is Not AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 07MAY19

Send Inquiry about this Production Line
Commercial Manufacturing cGMP Facility   Multiple US and EU Production Suites
Location: Memphis, TN, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
GMP Level:  Phase IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  AllAll
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: 07MAY19

Send Inquiry about this Production Line

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