Clinical cell manufacturing facility dedicated to the production of stem cells and cell-based gene therapies
The facility is fully equipped to manufacture autologous and allogenic stem cells formulated for direct intravascular injection into patients.
COMPETITIVE ADVANTAGE
We are the first therapeutic cell manufacturing facility in Canada to adopt purpose-built and customized BioSpherix Xvivo isolator units for cell processing. These units provide complete environmental control/monitoring during the entire process. The systems are buffered from the external environment, provide an exceptionally clean work space, and all steps of cell manufacturing from microscopic observation through centrifugation can be performed in a single unit. The precise environmental control (gases, temperature, humidity etc.) makes our facility ideal for early stage product development as duplication of environmental conditions can be verified as the therapy moves to more advanced production systems applicable to later phase trials.
Our facility has highly trained staff and extensive expertise in the production of enhanced or gene-modified cell therapy products for use in humans.
- Two separate cell manufacturing suites, Suite #1 contains three ISO 7 clean rooms, Suite #2 contains two ISO 7 clean rooms
- Capable of running up to 6 distinct clinical trial protocols at once
- Cell manufacturing services/adherent cell processing
- Controlled rate freezing
- Cell cryobanking
- Sterile product processing/quality control testing
- Environmental monitoring
- Cell processing in large scale bioreactors
- Healthcare and social services
- Life sciences, pharmaceuticals and medical equipment
- Manufacturing and processing
Specialized labs and equipment
| Specialized lab | Equipment | Function |
|---|---|---|
| GMP Cell Manufacturing Facility | 4 BioSpherix Xvivo units | All equipment PQ, calibrated and monitored |
| 3 Tissue culture CO2 incubators | ||
| 2 -80°C & three -20°C freezers | ||
| 3 4°C fridges | ||
| 1 Biosafety cabinet hood | ||
| 4 centrifuges | ||
| 3 phase and Hoffman-equipped inverted microscopes | ||
| 3 digital cameras | ||
| sterile tubing connector | ||
| Biosafe Sepax-2 cell separation unit | ||
| Spectra Optia Apheresis unit | ||
| Static and dynamic particle counters | ||
| Two liquid nitrogen vapour phase freezers | ||
| Controlled-rate freezer | ||
| Smart-vue monitoring system |
Private and public sector research partners
- Canadian Institutes of Health Research
- Ottawa Hospital Research Institute