CELLnTEC’s HIGHER CERTIFIED (HC) PRODUCTS
Higher Certified (HC) culture media are used in translational bench-to-bedside research projects. They enable a seamless transition from the development of cell-based therapies into clinical trials.
HC culture media are manufactured using upgraded ingredients and processes and are successfully being used in a range of phase of Phase I and II clinical trials. These media are ideally suited for use during early stages like product development, protocol validation, and characterization of the cell-based product before entering clinical trials. Utilization of HC media for the early phases ensures:
All processes and products are finalized using the identical medium formulation that will be used during the clinical trials
Sources of variability are eliminated
Re-validation of protocols following a change in culture medium ingredients is not required
All data submitted for regulatory approval are obtained using the identical products and processes that will be used clinically