In 1995, DIZG - the German Institute for Cell and Tissue Replacement - produced the first cultured autologous skin for clinical use. This culture played a major role in the life-saving treatment of a patient who was severely burned. Today, the institute’s Biotechnology Division is still engaged in making cultured autologous skin for such patients in burn centers.
However, the treatment of burn patients who no longer have sufficient healthy skin to close the wound poses a major challenge for medicine. Transplants of human skin cell are used on patients when over 60% of body surface is marked by grade 2 or 3 burns.
Preparation of Cell Cultures
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Figure 1. Growing cell cultures.
DIZG holds a manufacturing license as per the §13 AMG (German Medicines Act). Such cell cultures have been termed as "Advanced Medicinal Therapy Products (ATMPs). DIZG has submitted applications for approval with respect to AMG §4b by the required deadline at the Paul- EhrlichInstitut and anticipates issuance of three related permits by 2013. For cell culture preparation (Figure 1), DIZG has a 4-member team, a certified quality management system, and an ISO/GMP-compliant clean room area. For almost 20 years, the institute has contributed immensely in saving the lives of about 100 severe burns patients.
The following criteria are important for preparation of cell cultures:
- Incubator for human skin cell cultures
- Controlled humidification
- Homogeneous CO2 distribution
- Reliable sterilization
- Optimal use of space
- Minimized risk of contamination.
BINDER Incubators for Cell Cultivation
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Figure 2. CO2-incubator CB 150.
In order to incubate human skin cell cultures, the institute employs a number of BINDER incubators from the CB150 series (Figure 2). For cultivation, one to three tiny samples of healthy skin are taken from the patient. From these samples, the body's own epidermal cells are separated for ensuing reproduction in a unique culture system under standardized conditions. Following this, cell cultures are incubated in cell culture flasks in incubators at a temperature of 37°C and a supply of 5% CO2 under extreme humidity.
After a few days, small cell islands begin to form in the cell culture vessels. From these cell islands, epidermal cell suspensions can be collected to spray onto the wounds. After extended cultivation, epidermal membranes are harvested and placed on the wounds like a bandage. Within a period of three to five weeks, it is possible to grow such "sheets" to enclose a surface area of 0.5 to 1.5m2. The cultures can then be transported to the clinic by the transplant date agreed between DIZG and the treating physician.
Low Risk of Contamination
In order to produce human cell cultures for clinical use, it is necessary to obtain authorization granted by the Paul-Ehrlich-Institut according to AMG §4b or authorization granted by the EMA according to ATMP, as well as production authorization granted by the local regional health authority according to AMG §13. Cultivation is performed in stringently controlled class A and B clean rooms.
Gabriele Dietz, medical technology director at DIZG, informed that is it very important to ensure that contamination risk is kept as low as possible. BINDER incubators meet this specific requirement, thanks to their sterilization capabilities and surfaces that can be disinfected. Racks, fans, fixtures, etc. in traditional incubators often pose a risk of contamination. In BINDER incubators, hidden contamination areas are removed by a seamless deep-drawn inner chamber made of stainless steel. This unique minimization of contamination surfaces ensures the highest safety.
CO2 Incubators CB 150 features a patented BINDER technology and provides hot air sterilization at 180°C. It is suitable for in vitro fertilization (IVF), bio-tissue engineering, clinics and university hospitals.
Conclusion
DIZG supplies human cell and tissue transplants to numerous hospitals, doctors' offices and clinics located at both local and international levels. The institute is certified according to DIN EN ISO 13485 and follows the quality standards and ethical code of the European Association of Tissue Banks (EATB).
This information has been sourced, reviewed and adapted from materials provided by BINDER GmbH.
For more information on this source, please visit BINDER GmbH.