Cell Therapy Services

Cognate Offers Client Stem Cell Services:

  • Cell Characterization for Purity and Identity by Flow Cytometry and for Multipotency by Differentiation Assays
  • Molecular Biology Capabilities and Expertise Including Vector Design and Engineering, Transfection and Transduction
  • Preclinical Services
    • GLP cell manufacturing with expertise in isolation and culture of stem cells from various tissue sources
    • Various preclinical studies including immunologic studies for immunogenicity of cell products
    • GLP study auditing
  • Manufacturing Process Validation from Design to Implementation
  • Large-Scale cGMP-Compliant Production of Cells for Process Development, Clinical Trials and Commercial Applications Including the Use of Closed System Configurations
  • Availability of specialized equipment on site including an irradiator within one of our clean room suites
  • Preparation of FDA or Int’l equivalent Investigational New Drug Application/CMC Packages
  • Expertise in Int’l Technology and Process Transfer across regulatory guidelines Including GMP/GLP Documentation, Raw Materials Specifications, SOPs, QA/QC, Materials
  • Management, Facilities and Metrology
  • Stability Testing for Cell Culture Components and Products