EpiOral and EpiGingival In Vitro Testing
- FDA Registration FEI# 1000151293 as a GMP/GLP/GCP Drug Establishment and Cosmetic Facility.
- DEA Registration# RC0199744 (Analytical Lab) | Schedule I-V license | Remember, Schedules I-II require DEA Form 222 | Registration# RC0171568 (Researcher)
- US EPA/NJ DEP Registration# NJD982726648
- ISO/IEC 17025:2017 Accreditation# 80071
Testing at CPT℠ is performed using MatTek’s EpiOral™ and EpiGingival™ tissues to assess the oral irritation potential of raw ingredients and finished products, including over-the-counter oral care formulations and medical devices. The tissues consist of normal, human-derived oral epithelial cells. The cells have been cultured to form multilayered, highly differentiated models of the human buccal (EpiOral™) and gingival (EpiGingival™) phenotypes. The tissues are cultured on specially prepared cell culture inserts using serum free medium and attain levels of differentiation on the cutting edge of in vitro cell culture technology. The EpiOral™ and EpiGingival™ tissue models exhibit in vivo-like morphological and growth characteristics which are uniform and highly reproducible.
The testing involves applying the formulation or chemical directly to the apical surface of the 3D cell culture insert.
After exposure of these formulations at predetermined intervals, a viability assessment is done to determine an ET-50 value using an MTT Viability Assay. This determines the exposure time required to reduce tissue viability by 50%. This MTT assay uses a tetrazolium salt which is converted to a colored formazan product by viable cells and is measured on a Microplate Reader and then analyzed to determine the ET-50 value or irritation potential.