Ontario’s first Good Manufacturing Practice (GMP) manufacturing facility dedicated to oncolytic virus production.
- 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.
- 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.
- Life sciences, pharmaceuticals and medical equipment
- Manufacturing and processing
Specialized labs and equipment
|
Specialized lab |
Equipment |
Function |
|---|---|---|
|
OHRI GxP Assay Lab |
Tissue Culture CO2 incubators (2) |
|
|
|
-80°C Freezer |
|
|
|
-20°C Freezer |
|
|
|
4°C fridge |
|
|
|
Biosafety cabinet hood |
|
|
|
ViCell |
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 |
|
|
|
Shaker |
|
|
|
Tube Sealers (2) |
|
|
|
Tube Fuser |
|
|
|
Microscope |
|
|
CHEO GLP Facility |
Janus Automated Workstation with Liquid Handler |
|
|
|
Biosafety cabinet hood for Robot |
|
|
|
Spectrophotometer |
|
|
|
Centrifuge |
|
|
Animal Facilities - ACVS |
Small Animal MRI & IVISÒ In Vivo Imaging System |
|
Private and public sector research partners
- Jennerex Biotherapeutics (US)
- Transgene (France)