Process Development

Our Comprehensive Package of Process Development Services:

  • Optimization of Cell Culture Conditions for Adherent and non-Adherent Cell Types
  • Including Feed, Passage, Wash Procedures and Formulation
  • Scale-up of Cell Cultures for Manufacturing, including the Use of Closed System Configurations
  • Development and Optimization of Cryopreservation Methods
  • Development and Testing of Master and Working Cell Banks
  • Development of Various Assays Including, but not limited to:
    • Immune monitoring assays, Oligo and antibody based microarray analysis
    • Antibody response monitoring assays
    • In vitro and in vivo immune response assays
    • Cell activation and proliferation assays
  • Stability Testing for Customized Cell Culture Components and Products
  • Quality Control In-Process and Product Lot Release Assay
  • Technology Transfer of Client-Developed Processes to Cognate from and to various Int’l Regulatory Environments
  • Process Technology Transfer of Cognate-Developed Processes to Domestic and International Clients in Compliance with Multiple Regulatory Agencies
  • Development of Critical Process Parameters for Validation
  • Isolation of Hematopoietic Subsets