Other Properties
Tissue
Kit: A standard EpiCorneal kit (COR-100) consists of 24 tissues. (Tissue "kits" contain tissues, a small amount of culture medium, and plasticware; contact us for specific kit contents)
Formats: 9mm individual inserts – tissue culture substrate is chemically modified with a pore size of 0.4 μm
Culture: Air-liquid interface
Histology: 4-5 cell layers – stratified, squamous morphology and tissue structure
Lot numbers: Tissue lots produced each week are assigned a specific lot number. A letter of the alphabet is appended to the end of the lot number to differentiate between individual kits within a given lot of tissues. All tissue kits within a lot are identical in regards to cells, medium, handling, culture conditions, etc.
Shelf life: Including time in transit, tissues may be stored at 4°C for up to 3 days prior to use. However, extended storage periods are not recommended unless necessary. In addition, the best reproducibility will be obtained if tissues are used consistently on the same day, e.g. Tuesday afternoon or following overnight storage at 4°C (Wednesday morning)
Cells
Type: Normal human corneal epithelial cells (HCEC)
Genetic make-up: Single donor
Derived from: Healthy donor
Screened for: HIV, Hepatitis-B, Hepatitis-C, mycoplasma
Medium
Base medium: Dulbecco's Modified Eagle's Medium (DMEM).
Growth factors/hormones: Epidermal growth factor, insulin, hydrocortisone and other proprietary stimulators of corneal epithelial differentiation.
Serum: None.
Antibiotics: Penicillin (50 U/ml) / Streptomycin (50 µg/ml)
Anti-fungal agent: Amphotericin B (0.125 µg/ml).
pH Indicator: Phenol red.
Alternatives: Phenol red-free, antibiotic/anti-fungal-free, or hydrocortisone-free medium and tissue are available. Agents are removed at least 3 days prior to shipment.
Maintenance medium: Most experiments with EpiCorneal™ are performed within 48 hours. However, for longer experiments, the tissue can be maintained in COR-100-MM (identical to EpiCorneal™ assay medium).
Quality Control and Sterility
Visual inspection: All tissues are visually inspected and if physical imperfections are noted, tissues are rejected for shipment
Sterility: All media used throughout the production process is checked for sterility. Maintenance medium is incubated with and without antibiotics for 1 week and checked for sterility. The agarose gel from the 24-well plate used for shipping is also incubated for 1 week and checked for any sign of contamination
Screening for pathogens: All cells are screened and are negative for HIV, hepatitis B and hepatitis C using PCR. However, no known test method can offer complete assurance that the cells are pathogen free. Thus, these products and all human derived products should be handled at BSL-2 levels (biosafety level 2) or higher as recommended in the CDC-NIH manual, "Biosafety in microbiological and biomedical laboratories," 1998.
Notification of lot failure: If a tissue lot fails our QC or sterility testing, the customer will be notified and the tissues will be replaced without charge when appropriate. Because our QC and sterility testing is done post-shipment, notification will be made as soon as possible (Under normal circumstances, ET-50 failures will be notified by Wednesday 5 p.m.; sterility failures will be notified within 8 days of shipment)