Therapeutic Cell Manufacturing Facility

Therapeutic Cell Manufacturing Facility

Institution
The Ottawa Hospital
Address

501 Smyth Road

Ottawa, ON K1H 8L6
General contact
David Courtman
Scientist

Regenerative Medicine

T: (613) 737-8899 x79181
E: dcourtman@ohri.ca
Research contact
Samantha Hodgins
Facilities and Operations Manager

Regenerative Medicine

T: (613) 737-8899 x75542
E: samhodgins@ohri.ca
Published date: Jan 22, 2014
What the lab/facility does

Clinical cell manufacturing facility dedicated to the production of stem cells and cell-based gene therapies.

Sectors of Application
Health care and social services; Life sciences, pharmaceuticals and medical equipment; Manufacturing and processing
Area(s) of expertise

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.

Research Services
  • Two separate cell manufacturing suites each containing two ISO 7 clean rooms,
  • Capable of running 4 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
Specialized labs and equipment

Name of specialized lab

Name of equipment

Description of function

GMP Cell Manufacturing Facility

3 Biospherix Xvivo custom isolator platforms

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

 

 

Rees monitoring system

 

 

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

 

Private and public sector research partners
  • Canadian Institutes of Health Research
  • Ottawa Hospital Research Institute

GMP Manufacturing Suite Floor Plan

Credit: GMP facility/OHRI


Biospherix X-Vivo Custom Unit

Credit: Facility Stock Photo