Mulcahy Family Manufacturing Facility

The Ottawa Hospital, Ottawa, Ontario
What the facility does

Ontario’s first Good Manufacturing Practice (GMP) manufacturing facility dedicated to oncolytic virus production.

Areas of expertise
  • On-site QA department, production manager, facility manager, QC technicians, process and assay development technicians, and 5 full-time GMP-trained staff with a combined 40 years of GMP manufacturing experience.
  • Staff has produced clinical products for phase 1 and 2 clinical trials released in Canada, the US, and South Korea.
  • Fully aseptic manipulation qualified and gown qualified for ISO 6/Grade B cleanroom.
  • Dedicated GxP assay facility able to perform several biochemical, potency, and identity assays
  • Experienced staff in assay development, SOP writing, and assay validation for GMP release and characterization testing of biological products, for GLP toxicity study sample analysis, and for GCLP clinical sample analysis.
  • Experienced staff in production process development, specifically with optimization of tangential flow filtration and other filtration steps, cell culture, virus infection, harvest, and purification.
  • The facility boasts a GMP-compliant and controlled material management system
  • GMP, QA-released on-site VERO and HeLa Cell Banks
  • There is a comprehensive environmental and personnel monitoring system coupled to a rigorous cleaning program, which includes vapourized hydrogen peroxide fumigation.  The cleaning program is qualified for consistency and validated for its ability to inactivate current products.
  • The outer GMP area has several controlled and monitored -80°C, 4°C, -20°C, and liquid N2 freezers.
  • All equipment is qualified, calibrated, and QC-monitored daily, weekly with chart recorders, and 24/7 with an electronic monitoring system that notifies staff upon technical excursions.
Research services
  • A 37 m2 (398 ft2) ISO 6/Grade B compliant production clean room
  • Specially designed to manufacture containment level 2 viruses
  • Facility has both gowning and de-gowning airlocks for proper personnel flow

RollerCell 40 (RC40) incubator and rotor:  Permitting the simultaneous production from 40 extended roller bottles with a combined 170,000 cm2 of cell growth surface area,

Other equipment in the production area: Includes a large 37°C incubator, ISO 5 BSC hood, several scales, pumps, and a Tangential Flow Filtration system for concentration and purification,

Facility qualifications: Staff audited by Transgene (France QP); qualified for manufacturing clinical batches for Europe/ Staff have produced oncolytic virus products approved by FDA for use in Phase IIb trials in US. Group has manufactured virus products released for use in early phase trials around the world.

Sectors of application
  • Life sciences, pharmaceuticals and medical equipment
  • Manufacturing and processing

Specialized lab



OHRI GxP Assay Lab

Tissue Culture CO2 incubators (2)



-80°C Freezer



-20°C Freezer



4°C fridge



Biosafety cabinet hood




 Cell analyzer


qPCR machine



Tissue Lyser



Palltronic Tissue Filter Integrity Tester

 Allows for QC filter integrity testing by bubble point test


2 Environmental Monitor (EM) incubators

QC lab for GMP facility EM

OHRI GMP Facility

-80°C freezers (3)



-20°C freezer



4°C fridges (2)



Liquid nitrogen tank



Roller Bottle 40 Incubators (2)

One for GMP and one for Process Development)


Biosafety cabinet hoods (3)



Viable particle measurer

For EM and Cleaning


Vapourized hydrogen peroxide generator

For EM and Cleaning


Air particle sampler

For EM


ISO 5 glovebox containing a vialing and stoppering robot

For Vialing


Vial crimper

For Vialing


Tangential Flow Filtration system



Cole Parmer Pumps (2)



Spectrum Pump



Small & large-scale 






Tube Sealers (2)



Tube Fuser





CHEO GLP Facility

Janus Automated Workstation with Liquid Handler



Biosafety cabinet hood for Robot








Animal Facilities - ACVS

Small Animal MRI & IVISÒ In Vivo Imaging System


  • Jennerex Biotherapeutics (US)
  • Transgene (France)