FACILITIES


Cognate is headquartered in Baltimore, MD USA, housing our research and development and process development laboratories.
Cognate’s state of the art cGMP facility is strategically located in Memphis, TN USA – a worldwide air hub for both FedEx and UPS, enabling Cognate to send and receive shipments from anywhere in the US within 24 hours, with multiple choices of carriers. This enables Cognate to handle both fresh and frozen cell products of all types.



Compliant cGMP Facility and Systems

  • Fully qualified cGMP Cell Isolation and Expansion Facility
  • Licensed and inspected by Tennessee State Board of Pharmacy as well as FDA inspected with no 483 findings
  • Multiple class 10,000 (ISO 7) Production/Cell Culture Suites Supported by Individual Air Handling Systems
  • Full Service Analytical and Micro Laboratories for All Standard Analytical In-Process and Release Testing and Routine Monitoring of Production Suites
  • Validated—Siemens APOGEE Building Monitoring system for All Critical Systems, Equipment and Environmental Chambers
  • Robust Planning and Scheduling Systems
  • QA Systems Including: Corrective Action and Preventive Action (CAPA) Program, Vendor Audit Program and Change Control
  • Cryogenic Storage, Distribution, and Tracking Systems

Cognate Offers the Broadest Array of Experience and Services


Key Management and Technical Personnel With Average of 15 Years Experience in Cell Therapy Manufacturing Development:

  • Master and working cell banks
  • Fill finish services
  • Process development and scale-up
  • Genetically modified cells and/or irradiated cells (on-site irradiator)
  • FDA Investigational New Drug CMC Packages and equivalent documentation for International Regulatory Agencies
  • Stability and shipping studies (nearly 24 hour shipping possible, via proximity to FedEx hub)

Clinical and Commercial Manufacturing

  • Process transfer, optimization and validation
  • Large-scale cGMP-compliant cell manufacturing (efficient scale up)
  • Ability and expertise to manufacture both adherent and suspension based cells
  • Packaging, storage and shipment to US and international clinical sites (5 minutes from worldwide FedEx hub in Memphis)

Assay Development and Optimization

  • Cell product characterization, QC in-process, and lot release assays for identity and purity
  • Qualification and validation for pivotal trials or registration