Cell Manufacturing
The Cell Manufacturing Facility (CMF) was established in 2010 and began cellular therapy production for Canadian clinical trials in 2013. The CMF is a FACT accredited state-of-the-art facility operating under GMP principles to develop novel autologous and allogenic cellular and cell-based gene therapies for use in Phase I/II clinical trials. Members of the CMF provide regulatory support and process development expertise for Canadian Clinical Trial Applications. The facility is a founding member of CellCAN, the Canadian-wide network of cell manufacturing facilities efforts to improve and expedite the roll out of cell therapies across Canada.
The Facility
The CMF is comprised of two clean room suites totalling approximately 3000 ft2 which have been designed and constructed specifically for human clinical cell processing, complete with five HEPA-filtered certified cleanrooms. All cell processing is conducted within a custom-designed BioSpherix Xvivo Closed Incubation System. The BioSpherix is a flexible modularly designed unit operating at better than ISO 5. All cell/material manipulation is conducted inside the closed system which is continuously HEPA filtered with medical grade and filtered gas input from supply tanks. The isolator provides superior contamination control, products and personnel are never in the same space, virtually eliminating any risk of contamination from operators and risk of cells affecting the operators.
Manufacturing
The CMF manufactures cell therapy products for development work in support of clinical trial applications and products for clinical trials approved under the Clinical Trial Application (CTA) procedures in Canada.
The CMF has completed four cell therapy clinical trials to date including:
- The Enhanced Angiogenic Cell Therapy - Acute Myocardial Infarction Trial (ENACT-AMI)
- Cellular Immunotherapy for Septic Shock (CISS)
- Mesenchymal Stem Cell Therapy for Canadian Multiple Sclerosis Patients (MESCAMS)
- Cellular Immuno-Therapy for COVID-19 Acute Respiratory Distress Syndrome (CIRCA-19)
The CMF is currently actively manufacturing cell therapy products for two Health Canada approved clinical trials:
- Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension
- Cellular Immuno-Therapy for COVID-19 Acute Respiratory Distress Syndrome (CIRCA-1902).
With the extensive knowledge and expertise of personnel, state of the art clean rooms and support of the Ottawa Hospital Research Institute, the Biotherapeutics Manufacturing Center Cell Manufacturing Facility has proven to be one of Canada’s key resources for providing access to cellular therapies and positioning Canada as a world leader in regenerative medicine.
