Mulcahy Family Manufacturing Facility

The Ottawa Hospital, Ottawa, Ontario
Area(s) of Expertise

FACILITY 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.
     

COMPETITIVE ADVANTAGE

  • 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.
What the facility does

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

Research Services

FACILITY 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

Name of specialized lab

Name of equipment

Description of function

OHRI GxP Assay Lab

2 Tissue Culture CO2 incubators

 

 

-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

3 -80°C freezers

 

 

-20°C freezer

 

 

2 4°C fridges

 

 

Liquid nitrogen tank

 

 

2 Roller Bottle 40 Incubators (one for GMP and one for Process Development)

 

 

3 Biosafety cabinet hoods

 

 

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

 

 

2 Cole Parmer Pumps

 

 

Spectrum Pump

 

 

Small & large-scale 

 

 

Shaker

 

 

2 Tube Sealers

 

 

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

 

  • Jennerex Biotherapeutics (US)
  • Transgene (France)