Dr. Linda Rasooly. is the director of the GMP facility at the Gene Therapy Institute.
The GMP facility is responsible for all aspects of GMP compliance in providing Phase I-III manufacturing facility to external companies as well as internal research groups in Hadassah. The main areas of activity include:
-
Provision of a functioning facility with controlled environment/clean rooms that are monitored online by the facility monitoring system
-
Facility cleaning including the clean rooms
-
Calibration and maintenance of the equipment under Hadassah responsibility
-
Initial training and ongoing oversight of contract giver personnel on facility SOPs
-
Handling of deviations related to the facility and reports from the contract givers regarding any deviations with the potential to affect the facility such as environmental monitoring deviations
-
Managing change requests related to the facility whether initiated by Hadassah or the contract giver
-
Maintenance of documents and records related to the activities under Hadassah’s responsibility and authority
The facility has been inspected and accredited for phase 3 clinical trials by the Israeli Ministry of Health. Currently, the GMP accreditation is in effect until May 2022. Two Israelis Companies are currently working in the facility, Brainstorm and Gamida Cell.