cGMP Manufacturing

Cognate Operates a cGMP Compliant Manufacturing Facility

  • Experienced Manufacturing and Quality Staff in cGMP Manufacturing of Cell-Based Products
  • Validated Class 10,000 (ISO Class 7) Production Suites
  • Quality Control (QC) and Process Development Laboratories

Our Comprehensive Package of Cell-Based cGMP Product Manufacturing Services:

  • Large-Scale cGMP-Compliant Production of Cells for Clinical Trials up to Commercial scale, Including the Use of Closed System Manufacturing Configurations
  • Preparation of cGMP Master and Working Cell Banks
  • Fill Finish Services
  • Cryopreservation Process Development and Optimization
  • Manufacturing Process Validation from Design to Implementation
  • Materials Management
  • Preparation of Raw Material Specification, SOPs and Batch Production Records
  • Shipping Validation Protocols
  • Quality Control Testing
    • cGMP assay transfer to QC and assay qualification/Validation
    • Bioburden, mycoplasma and endotoxin testing
    • Design and implementation of product release QC testing and characterization assays (including functionality assays)
    • Stability testing for customized cell culture reagents and products