GMP Production Rooms
The GMP Facility for the Production of Biopharmaceuticals and Vectors
The main objective of the GMP Production Facility at the Goldyne Savad Gene Therapy Institute is the production of vectors and cells for use in human gene therapy clinical trials, primarily vectors for use in Phase I/II the trials.
We provide GMP production rooms for those investigators who wish to produce their delivery systems in a standard and approved environment staffed by investigators knowledgeable in the GMP production of biologicals. This unit will also provide technical support to investigators in drafting their standard operation procedures (SOPs), and in performing their study
* physical design of the facility
* air handling
* maintenance and services
* standard operating procedures and policies
* our team (members, current projects, contact information)
Physical design of the facility
The facility occupies about 300 m2. It operates in compliance with current Good Manufacturing Practices (cGMP). Access to the facility is limited to authorized personnel who may enter by activating an electrical door using a personal magnetic card.
The facility consists of two functionally and physically separate areas:
1. A "gray" area, which includes a storage room for materials and reagents, offices, a staff meeting room, a Quality Control (QC) lab outfitted with cell culture and molecular biology equipment, and a chemical fume hood. Adjacent to the QC there is a room for low temperature (-80ºC) freezers.
2. A "white" area, with three separate production laboratories, a module for final formulation filling and common supportive facilities. The QC lab can be transformed into a fourth controlled module and the low temperature freezers room can function as an air lock vestibule with interlocked double doors.
The "gray" and "white" areas are separated by an air lock vestibule with interlocked double doors, which serves as a gowning room. All the modules in the "white area" and in the QC lab are made of prefabricated panels. In order to prevent cross-contamination, access to each one of the production modules and to the aseptic filling room is through additional interlocked double door vestibules, which serve for degowning and re-gowning before entering or leaving each of the production areas.
The common facilities in the "white" area consist of a media and buffer preparation room and a glassware wash room with a pass-through autoclave, in which equipment is sterilized in double plastic bags. One door of this autoclave opens onto the wash room, and the other - onto the "clean tools" room, where sterilized equipment is kept. Biological waste disposal is carried out in a separate pass-through autoclave, with one door on the "white" area and one door on the "gray" area.
Air handling
Air supply to the different zones is controlled by separate air handling units. Air is supplied through highly efficient particulate air (HEPA) filters, under positive pressure. The HEPA filters provide class 100,000, class 10,000 and class 100 environments to the different rooms of the controlled area. For instance, in the aseptic filling room the airborne particles are reduced to 100 particles per cubic feet. Additionally, each one of the three production modules (Class 10,000) contains a biological safety cabinet that provides a Class 100 environment.
For containment purposes, positive air pressure, relative to the adjacent production modules, is maintained in the air lock vestibules. Positive air pressure is also maintained in the corridor, relative to the air lock vestibules.
Maintenance and Services
Maintenance of the equipment for the supply of air, air conditioning, electricity, vacuum, CO2 and additional gasses is carried out from outside of the production areas. In addition, a computerized alert program monitors the rooms and major pieces of equipment located in them, for deviations in temperature, humidity, vacuum, and CO2 content.
The equipment is calibrated periodically and maintained according to GMP requirements by the facility maintenance personnel.
The cleaning of production laboratories is performed on a daily basis by a dedicated facility worker. Cleaning of other areas in the facility is performed on a weekly or monthly basis.
Prospective researchers, please contact:
Linda Rasooly, Ph.D.
Lindar@hadassah.org.il
Hadassah University Hospital
POB 12000
Jerusalem 91120, Israel
Phone: 972-2-677-6793
Fax: 972-2-643-0982