EpiVaginal 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
EpiVaginal In Vitro Testing at CPT℠ uses MatTek’s EpiVaginal™ tissue, which is an in vitro, non-animal alternative for the safety and irritation potential testing of products, especially feminine care and intimate care hygiene products, contraceptive products, lubricants, and personal care washes that come in contact with the female reproductive tract.
MatTek’s EpiVaginal™ tissues are based on normal, human-derived VEC epithelial and dendritic cells (DC).
All VEC tissues are cultured on specially prepared cell culture inserts and are multilayered and highly differentiated. This laboratory-engineered tissue closely mimics the structure, thickness, metabolic activity, and cellular physiology of live human vaginal tissue.
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.