Cell Manufacturing

BMC’s Cell Therapy Manufacturing Facility is designed to manufacture state-of-the-art cell-based therapies for the treatment of acutely or chronically ill patients at The Ottawa Hospital. The facility can produce many kinds of cells (i.e. stem, progenitor somatic) with and without transfection.

The facility is a founding member of CellCAN, the Canadian-wide network of cell manufacturing facilities. Through CellCAN, facility members actively participate in the design and execution of multi-center cell-therapy trials as well as the dissemination and implementation of Canadian regulatory guidelines.

The facility is currently the primary manufacturing site for three Health Canada authorized clinical trials:

  • Enhanced Angiogenic Cell Therapy – Acute Myocardial Infarction (ENACT-AMI)
    • This trial is a phase IIb, double-blind, randomized placebo-controlled trial of genetically transfected autologous endothelial progenitor cells in patients who have experienced a myocardial infarction.
    • Details on clinicaltrials.gov.
    • Details for the general public.
  • Cellular Immunotherapy for Septic Shock (CISS)
    • This is a phase I dose escalation safety trial of allogeneic mesenchymal stem cell (MSC) obtained from healthy bone marrow donors for the treatment of septic shock
    • Details on clinicaltrials.gov.
    • Details for the general public.
  • Mesenchymal Stem Cell Therapy for Canadian Multiple Sclerosis Patients (MESCAMS)
    • This is a phase I/II "proof-of-principle" study to examine the feasibility, safety and potential benefit of autologous MSC therapy for inflammatory forms of multiple sclerosis (MS).
    • Details on clinicaltrials.gov.
    • Details for the general public.

To facilitate these clinical trials, two suites, each with two processing rooms, have been designed and built for cGMP processing which incorporates uniquely designed isolator technology to speed work-flow, limit costs, and increase product safety. The cell manufacturing facilities is operated under the auspices of a qualified director, with personnel trained in aseptic technique.

The Cell Therapy Manufacturing Facility also two novel cGMP suites consisting of four processing rooms for a total of approx. 2000 ft2

Cell Manufacturing GMP Suite (CMGS)

All cell processing is performed in the GMP production rooms, with the room environment operating to a minimum of ISO 8 standards. All open cell processing is performed in a custom designed isolation chamber (glove box) operating to ISO class 5 environment markedly reducing the risk of contamination.

BioSpherix Xvivo Closed Incubation System (BXCIS)

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 with the capacity for internal chlorine dioxide gas sterilization at defined intervals. All cell/material manipulation is done 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.

Process Analytical Technology

The isolator also provides superior process control with the ability to continuously monitor and control production in accordance with the FDA's Process Analytical Technology (PAT). If required, the atmosphere (O2, CO2, temperature, humidity, pressure and volatile organic compounds) inside the Xvivo system can be controlled automatically, and continuously with no interruptions.