Feb 28, 2018 – In December 2017, Israel’s Ministry of Health granted Hadassah’s Good Manufacturing Practice (GMP) biological production facility certification for standing as a GMP-compliant facility. This includes the possibility to produce biologicals for phase III studies. Hadassah’s world-class GMP laboratory, established by Prof. Eitan Galun, is where biological and cell based clinical trial materials can be produced by companies and by Hadassah researchers to use in their clinical trials. The facility is unique and the only such facility in Israel in a biomedical clinical institution. So far, the GMP Laboratory have produced over 50 products for human clinical studies in the Hadassah/Hadasit GMP approved facility.
The GMP facility occupies about 300 sqm and contains 4 operational grade B clean room 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. The GMP facility has carried out numerous academic and industrial projects with collaborators in Israel and abroad. These projects have involved manufacture of pharmaceutical quality DNA, proteins, viruses and cells.
Some examples are:
- Production of radioactive antibodies for cancer treatment
- Genetic engineering of skin tissues
- Viral vector production
- Oncolytic virus production (OVCure, Israel)
- Mesenchymal stem cell production (Hadassah and Teva, Israel)
- Amplification of cord blood stem cells (Gamida Cell, Israel)
- Production of embryonic stem cells (Hadassah, Israel)
- Production of tumor antigen-loaded dendritic cells (Hadassah, Israel)
- Cellular immunization production for treatment of multiple sclerosis (Hadassah, Israel)
- Production of coated sponges for wound treatment (Hapto Biotech, Israel)
- Mesenchymal stem cell production (Brainstorm, Hadassah)
The proximity of the GMP to the only university-hospital in Israel makes the translational activity most attractive. Dr. Linda Rasooly (lindaR@hadassah.org.il) is the management director of the facility and would be happy to answer any questions
Link to the GMP laboratory site: http://www.hadasit.org.il/service/hadassah-gmp-facility/
For more information, see: http://www.hadasit.org.il/wp-content/uploads/2018/02/Hadasit-Newsletter-Feb-2018.pdf#new_tab
