The Manufacturing
Process
The manufacturing process is deceptively simple. Its main function is to trick the extracted fibroblasts into believing that they are in the human body so that they communicate with each other in the natural way to create new skin.
Mesh scaffolding method
- Fibroblasts are thawed and expanded. The fibroblasts are transferred from the vials into roller bottles, which resemble liter soda bottles. The bottles are rotated on their sides for three to four weeks. The rolling action allows the circulation of oxygen, essential to the growth process.
- Cells are transferred to a culture system. The cells are removed from the roller bottles, combined with a nutrient-rich media, flowed through tubes into thin, cassette-like bioreactors housing the biodegradable mesh scaffolding, and sterilized with e-beam radiation. As the cells flow into the cassettes, they adhere to the mesh and begin to grow. The cells are flowed back and forth for three to four weeks. Each day, leftover cell suspension is removed and fresh nutrient is added. Oxygen, pH, nutrient flow, and temperature are controlled by the culture system. As the new cells create a layer of dermal skin, the polymer disintegrates.
- Growth cycle completed. When cell growth on the mesh is completed, the tissue is rinsed with more nutrient-rich media. A cryoprotectant is added. Cassettes are stored individually, labeled, and frozen.
Collagen method
- Cells are transferred to a culture system. A small amount of the cold collagen and nutrient media, approximately 12% of the combined solution, is added to the fibroblasts. The mixture is dispensed into molds and allowed to come to room temperature. As the collagen warms, it gels, trapping the fibroblasts and generating the growth of new skin cells.
- Keratinocytes added. Two weeks after the collagen is added to the fibroblasts, the extracted keratinocytes are thawed and seeded onto the new dermal skin. They are allowed to grow for several days and then exposed to air, inducing the keratinocytes to form epidermal layers.
- Growth cycle completed. The new skin is stored in sterile containers until needed.
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