Advanced cellular therapy laboratory

Any product intended to be infused on humans must be sterile and cells, by their nature, cannot be terminally sterilized. Product sterility is therefore ensured by manipulation in “asepsis”, which is guaranteed by separation of materials and people flows and by the use of sophisticated air treatment systems within cleanrooms.

Critical parameters such as differential pressures between rooms, particle counts, temperature and humidity are continuously monitored; moreover, all laboratory instrumentation requires qualification (IOPQ).

Production processes and analytical methods must be validated, and analysis methods should be those specified in the European Pharmacopoeia when described.

Clean room

The facility is equipped with two laboratories for cell therapy and one laboratory for gene therapy, together with another one designated for material preparation. Each laboratory is supplied with incubators, laminar flow hoods, microscopes and centrifuges.

Critical parameters of humidity, temperature, differential pressure between rooms, particle counts, and  % CO2 and temperature of incubators are monitored in continuous by a dedicated monitoring system.