CGMP Manufacturing Facilities for Clinical Trials
The facility is focused on translational research. The world class GMP laboratory operates according to FDA and EMA standards and is located within Hadassah University Hospital Campus with easy access to hospital laboratories, clinical wards and P3 laboratories. This arrangement provides a unique advantage for facilitating collaborative networks and accelerating the manufacturing for translational research associated with Phase I/II clinical trials.
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. 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
- 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
- Mesenchymal stem cell production (Brainstorm, Hadassah)