GMP production site

Head of the lab

Hadassah GMP production site

Our world class clinical 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. GMP staff has over 20 years experience facilitating companies in material production for clinical trials. The facilities are available for rent by the R&D teams of external companies and academic researchers.

Facilities Description

  • The GMP facility occupies about 300 sqm and contains 4 operational laboratories and other equipment, whereas the larges room is 26 sqm.
  • The rooms are marked ISO 5, Grade A at rest and ISO 7, Grade B in operation
  • Approved for mammalian and non-mammalian cell production 
  • 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

Manufacturing projects examples

GMP facility has provided services to various BioMed companies such as OVCure, Teva, Hapto Biotech, Brainstorm, Gamida Cell and more.
  • 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

Details

Basic equipment for aseptic production provided on the house:

- Grade A hoods
- CO2 incubators
- Centrifuges
- All clean room sampling equipment

Terms benefits:

- Flexible agreement term: from months to years
- Attractive commercial terms for long term or multiple laboratories use
- Monthly to quarterly payment schedule

Clients