EpiCorneal 3D人體組織模型（EpiCorneal 3D human tissu）

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EpiCorneal™

The EpiCorneal 3D human tissue model provides a highly predictive non-animal alternative to assess ophthalmic drug delivery, wound healing and tissue regeneration, disease modeling (e.g. dry eye) and corneal infection.

EpiCorneal™

The EpiCorneal 3D human tissue model provides a highly predictive non-animal alternative to assess drug delivery, infection, wound healing/tissue regeneration and disease modeling (i.e. Dry Eye).

MatTek’s EpiCorneal tissue model consists of normal human corneal epithelial cells cultured to form a stratified, squamous epithelium which closely parallels normal human corneal tissue. The corneal cells, cultured on specially prepared cell culture inserts with serum-free medium, differentiate to form a multi-layered structure.

TEM Analysis of EpiCorneal illustrates the presence of 1) microvilli, 2) tight junctions (white arrows), and 3) desmosomes (black arrows)

Tight Junction Protein ZO-1 (green)

Used in drug delivery and drug development, EpiCorneal is a mitotically and metabolically active tissue with barrier properties approaching those of the human cornea. EpiCorneal can be stimulated to release many cytokines known to be important in inflammation and diseases such as dry eye. Further, the advanced 3D tissue model expresses cornea specific drug transporters and metabolizing enzymes.

Barrier Properties of EpiCorneal compared to EpiOcular measured by transepithelial electrical resistance (TEER).

Gene Expression Analysis shows the expression of cornea specific markers, drug metabolizing enzymes and transporters including Aldehyde Dehydrogenase (ALDH3A1), Pyrimidine Nucleotide Oxidoreductase (TRXR1) and Mucin 4 (MUC4)

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 MatTek 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.

Shipment: At 4°C on medium-supplemented, agarose gels

Shipment day: Every Monday

Delivery: Tuesday morning via FedEx priority service (US). Outside US: Tuesday-Thursday depending on location

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. For further assistance, please contact your site Safety Officer or MatTek technical service

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)

MatTek公司是麻省理工學院兩個化學工程教授于1985成立的科技公司。1991年，該公司利用其核心的聚合物表面改性技術進入新興的組織工程領域，目前已成長為的組織工程技術公司，致力于生產創(chuàng)新性的3D重構人體組織模型，該模型相較于傳統(tǒng)2D細胞模型具有更可靠的實驗結果。其生產的重構皮膚，眼部和呼吸道組織模型已廣泛應用于化妝品，化工，醫(yī)藥和家用產品等行業(yè)的毒理學監(jiān)控（OECD，歐盟的指導方針）及毒理學研究。

MatTek公司的基于人體細胞的3D皮膚模型EpiDerm于1993年研發(fā)上市，立即獲得巨大的成功。從此MatTek通過以下方式*改變了基于人體細胞的體外模型市場：

（1）低成本（降低50-80％的成本）；

（2）通過發(fā)表質量控制標準（同時具備陽性和陰性對照）以確?？蔀樾袠I(yè)及監(jiān)管機構接受的高可重復性水平；

（3）優(yōu)化研究人員的實驗結果。通過創(chuàng)造性使用非動物的體外測試，融合降低(直接/間接)成本的強大協(xié)同效應及顯著提高的產品質量，MatTek極大的降低產品成本、提高實驗室效率及高質量的高可重復性產品，減少實驗動物的使用，具有無可超越的長期組織可重復性；3-D仿真結構；高度分化的組織模型；代謝和分裂活性；源于正常的人體細胞；培養(yǎng)、操作簡便；無血清培養(yǎng)；可定量的客觀檢測；物美價廉的優(yōu)點。因而使得MatTek人細胞來源的體外組織模型被包括美國、加拿大、歐洲、日本和東亞的眾多跨國公司與研究機構采用。

目前MatTek公司的產品主要包括EpiDerm（皮膚模型）、MelanoDerm（黑色素模型）、EpiOcular（眼周表皮模型）、EpiAirway（呼吸道上皮模型）、EpiDermFT(全厚的皮膚模型) 、EpiVaginal（陰道上皮模型）、EpiOral（口腔上皮模型）、 EpiGingivalTM（牙齦上皮模型）、Psoriasis tissue（牛皮癬組織模型）及樹突細胞。