The treatment of large-area burn patients who no longer have enough healthy skin intact to close the wound represents a major challenge for medicine. Human skin cell transplants are used on patients when more than 60% of body surface is covered by grade 2 or 3 burns. Such skin transplants have been grown at DZIG in BINDER incubators.
DIZG has had a manufacturing license according to AMG (German Medicines Act) since 2001. Such cell cultures have been classified as "Advanced Medicinal Therapy Products (ATMPs)" since 2011. DIZG filed appropriate applications for approval in regards to AMG by the required deadline at the Paul-Ehrlich- Institut and anticipates issuance of three corresponding permits over the course of 2013. For the preparation of cell cultures, DIZG has a 4-person team, an ISO/GMP-compliant clean room area and a certified quality management system.
To incubate human skin cell cultures, the institute uses several BINDER incubators of the CB150 series. Institute employees appreciate the optimal use of space of the chambers among other things. For cultivation, one to three postage-stamp sized samples of healthy skin are taken from the patient. From the samples, the body's own epidermal cells, so-called keratinocytes, are isolated for subsequent reproduction in a special culture system under standardized conditions. Cell cultures are incubated in cell culture flasks in incubators at 37°C and a supply of 5% CO2 under high humidity. Small cell islands begin to form after just a few days in the cell culture vessels. From these islands, epidermal cell suspensions can be harvested to spray onto the wounds. After prolonged cultivation, epidermal membranes can be harvested, which are placed on the wounds like a bandage. Within three to five weeks, it is possible to cultivate such "sheets" to cover a surface area of 0.5 to 1.5 m². The cultures can then be delivered to the clinic by the transplant date agreed upon by the treating physician and DIZG.
Binder CB series CO2 incubators offer:
Homogeneous CO2 distribution due to gas mixing head with venturi effect
Drift-free infrared CO2 measurement system
PermadryTM humidity system for controlled humidification
Electronically controlled APT.lineTM preheating chamber technology
Seamless deep-drawn inner chamber made of stainless steel with integrated shelf support system
Standard-compliant hot air sterilization at 180 °C
Electronic self-diagnostic system