The cell factory


Features

The cell therapy facility will be fully operational in few months. The facility consists of three laboratories, outfitted with biosafety cabinets, incubators, centrifuges, microscopes, and other equipment needed for tissue culture. Cross-contamination between various spaces is minimized by standard operating procedures and an electronic door monitoring system. Consistent with GMP regulations, each laboratory has its own dedicated equipment, so that individual patient cell manipulations and/or cultures can be physically isolated. Fully redundant air handling systems are used to maintain class B air supplies. These rooms were built using clean room construction standards, and are routinely monitored for viable and nonviable air particulate counts and surface microbial contamination. All operations requiring open manipulations of patient tissues are carried out in class A air quality biological safety cabinets. Facility access is restricted to authorized, trained personnel.

European Good Manufacturing Practices

Medicinal products for human and veterinary use: Good manufacturing practices: Basic requirements and Annexes http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm