The Immunovative facility and equipment are properly qualified to perform cGMP manufacturing of the T-StimTM and AlloStim® products. The building is of suitable size, construction and location to facilitate cleaning, maintenance and proper operations. There is adequate space for the orderly placement of equipment and materials. Operations occur within specifically defined areas to prevent contamination or mix-ups. Adequate lighting is provided to all areas. Dedicated equipment for the control of air pressure, microorganisms, dust, and temperature are installed and operational. Air supplied to the production areas is properly filtered and there are adequate systems for exhaust, containment, cleaning and disinfecting to control contaminants. Clean area qualification is performed according to Fed Standard 209E. The testing specifications for each meet or exceed classification for clean rooms classed 100, 10,000, and 100,000. Particulate counts are performed per specifications set by ISO5, ISO7 and ISO8, which also exceed the classifications stated above.
Biohazardous waste is disposed of using a certified biohazardous waste removal/incineration service. The building is maintained in a clean and sanitary condition, free of infestation by rodents, birds, insects and other vermin and is maintained in a good state of repair. Trash and other refuse in and from the building are disposed of in a safe and sanitary manner.
Equipment used in manufacturing is of appropriate design, adequate size and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment is constructed so that surfaces are not reactive, additive, or absorptive. Equipment undergoes IQ/OQ and PQ procedures prior to being placed in the manufacturing facility and is certified, validated or calibrated semiannually as appropriate. Equipment is cleaned, maintained and sanitized according to written procedures at appropriate intervals to prevent malfunction or contamination.
All processing and formulation steps are conducted under a certified ISO 5 biosafety hood (Level A) located within a certified ISO 7 clean room (Level C). The facility is located at Immunovative Therapies Laboratories, at the Malcha technology park, Jerusalem. Regular microbiological environmental and personnel monitoring and cleaning SOPs are in place for preparation of the clean room at the beginning of a cell processing procedure and at the end of the processing. Only one product container of a batch or lot is open and processed in the clean room at any one time.