A glovebox with three levels of containment and clean room facilities for growing and handling biological material at physiologically correct gas compositions and with optimal quality assessment for tissue-engineering, ex vivo expansion, manipulation

摘要

Traditional two levels of containment provide enclosure and underpressure in order to avoid hazardous material to flow towards e.g. a crewmember and thereby cause severe harm. The present-day demands for laboratory safety have revealed a paradox: In the laboratory overpressure is needed to prevent contamination of biological material and under pressure is needed to prevent the pollution of the environment. A new type of combined workbench/incubator has been constructed to meet future regulatory demands for handling and growing human biological cellular material at safe constant physiological conditions: A so-called three levels of containment glovebox/workbench. This new invention avoids the hazards of prior technology. It sets new standards for proper handling of biological materials and will meet the coming safety demands from the growing field of tissue engineering and ex vivo biotechnology. The invention is computer controlled, has a build in cleaning facility for assuring a particle free and aseptic working facility. We now have invented a solution to the above paradox concerning laboratory safety that seems to fulfil the need for safe biological experiments in micrograv-ity. This concept has already been applied into ground-based research and is expected in a few years also to be applied similarly in the ISS environment. Furthermore, handling biological material mimicking in vivo conditions ex vivo requires precise and stabile monitoring and regulation of the isotherm and isobar conditions. Handling stem cells requires in addition low to very low oxygen tension to mimic the stem cells natural habitats. Besides that, the ex vivo gaseous atmosphere and temperature surrounding the cells has to be of same correct composition and temperature as found in the body in order to mimic in vivo situations in such way, that scientifically correct, reproducible and comparable results can be achieved. This fact is strengthened by forthcoming regulations as being prepared by several international regulatory bodies. The new concept will find its use in microgravity biotechnology and will set new standards on ground and in microgravity in the field of basic research, tissue-engineering , production of patient specific cells and tissue, embryo-genesis and in vitro fertilisation, ex vivo expansion of blood progenitor cells, gene therapy etc.