A seamless transition from LAB to CLINICAL TRIALS

A seamless transition from LAB to CLINICAL TRIALS

CELLnTEC’s Higher Certified (HC) products

Higher Certified (HC) culture media by CELLnTEC 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 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

Highlights of HC media

Higher Certified (HC) culture media differ from CELLnTEC’s standard research-grade media in the following ways, to meet progressing user needs with respect to the following criteria:

COMPONENTSClinically compatible, well documented, tight tolerances.
MANUFACTURINGTight documentation, dedicated equipment, additional process certification.
QC PROCESSAdditional Quality Control testing steps for all HC media.
DOCUMENTATIONExtended information regarding component origin, manufacturing processes, chemical composition.
CONSISTENCYProduct formulation will remain consistent. No changes will be made without prior notification to the end user.
SUPPORTAdditional range of services, including custom product documentation, advanced technical & scientific support, support with regulatory processes, lot reservation.
SERUM FREEHC media are chemically defined and serum-free *.

* The Higher Certified (HC) versions are supplied without serum supplementation for those products that do require serum in their standard research versions.
This enables the end-user to supplement with serum validated to deliver the desired cell behaviour and known to meet the necessary regulatory requirements.

CELLnTEC’s HC media portfolio

CATALOG NUMBERHC PRODUCT NAMEAPPLICATION
CnT-PR-HC CnT-Prime Epithelial Proliferation Medium, Higher CertifiedIsolation & Expansion
CnT-07-HCCnT-07 Epithelial Proliferation Medium, Higher CertifiedIsolation & Expansion
CnT-30-HCCnT-30 iPSC Epithelial Differentiation Medium, Higher CertifiedDifferentiation
CnT-40-HCCnT-40 Melanocyte Proliferation Medium w/o Serum, Higher CertifiedIsolation & Expansion
CnT-PR-ECM-HCCnT-Prime Fibroblast ECM Medium, Higher CertifiedDifferentiation
CnT-ENDO-HCCnT-ENDO Endothelial Proliferation Medium w/o Serum, Higher CertifiedIsolation & Expansion
CnT-PR-F-HCCnT-Prime Fibroblast Proliferation Medium w/o Serum, Higher CertifiedIsolation & Expansion
CnT-PR-KM-HCCnT-Prime Keratinocyte/Melanocyte Co-Culture Medium, Higher CertifiedCo-Culture
CnT-ISO-50-HCCnT-IsoBoost, Isolation Boosting Supplement, Higher Certified Isolation

For more information and quotes contact techsupport@caltagmedsystems.co.uk

A seamless transition from LAB to CLINICAL TRIALS