GMP production site
Our world class GMP laboratory operates according to FDA and EMA standards and is located in close proximity to the hospital laboratories, clinical wards and P3 labs. This arrangement provides a unique advantage, accelerating the processes for translational research associated with Phase I/II/III clinical trials. The service is available to external companies as well as internal research groups in Hadassah.
Facilities Description
The GMP facility occupies about 300 sqm and contains 4 operational class 10,000 laboratories and other equipment.
It operates under a strict Quality Control (QC) and Quality Assurance (QA) program.
Environmental cleaning and monitoring is addressed in a range of Standard Operating Procedures (SOPs) written specifically for this GMP facility.
Main Activities
- Controlled environment/clean rooms online monitoring system
- Calibration and maintenance of the equipment
- Initial training and ongoing oversight of contract giver personnel on facility SOPs
- Handling of deviations related to the facility
- Managing change requests related to the facility whether initiated by Hadassah or the contract giver
Examples of manufacturing projects
- Radioactive antibodies
- Viral vector
- Oncolytic virus
- Mesenchymal stem cell
- Embryonic stem cells
- Coated sponges for wound treatment
- Tumor antigen-loaded dendritic cells
- Mesenchymal stem cell production
- Amplification of cord blood stem cells
- Genetic engineering of skin tissues
- Cellular immunization production for treatment of multiple sclerosis
