How EPICEL is Made

To make EPICEL, a small biopsy of the patient’s healthy skin is obtained, placed into transport media, and packaged into a specially designed transport kit supplied by the Genzyme cell-processing facility. The biopsy is shipped to the cell processing facility where the cells (keratinocytes) are cultured aseptically for a period of several weeks to expand the cell population into many skin grafts. The resulting grafts are sheets of skin approximately 50 cm2 and two to eight cell layers thick. Upon completion and release, the grafts are hand-delivered by a Genzyme representative to the burn center operating room.

Making EPICEL requires two full-thickness, 2 x 6 cm biopsies of healthy skin, from two different sites, preferably the groin and axilla. These biopsies are then shipped to Genzyme in the provided skin Biopsy Transport Kit. Once the biopsies are received, the manufacturing process begins:

  1. Enzymatic Treatment. The epidermis is separated from the biopsies using Thermolysin, and transferred to a tube containing Trypsin – an enzyme that breaks down the protein that causes cells to adhere to each other. This is incubated at 37°C.
  2. Culture Initiation. Keratinocytes are released from the Epidermis and inoculated onto flasks plated with a feeder layer of irradiated 3T3 cells (mouse fibroblast cells) Although EPICEL is composed of autologous human cells from your skin; it is grown together with mouse cells and contains residual mouse cells. Because Epicel contains mouse cells; FDA considers it a xenotransplantation product. Certain safety measures identified by the Public Health Service (PHS) and FDA are recommended for EPICEL recipients: Never donate blood or blood parts, tissue, breast milk, egg, sperm, or other body parts for use in humans because of the potential risk of carrying an infection that is transmitted from mouse cells to humans.
  3. Culturing. Each lot is segregated from other lots and maintained at 37°C  for approximately 16 – 21 days as required to manufacture the needed quantity of EPICEL.
  4. Grafting. EPICEL lots are assembled and flasks are cut open to expose the culture. Each graft is attached to a rectangular petrolatum gauze backing with stainless steel surgical clips.
  5. Packaging. Grafts are placed into a specially designed, stainless steel shipping box. Refrigerant and CO2 are added, and the box is sealed.
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