Robert E. Fitzhenry Vector Laboratory

The Robert E. Fitzhenry Vector Laboratory has played a pivotal role in the development of immunotherapies in Canada. It was the first academic GMP facility in Canada that has manufactured viral vectors approved for use by Health Canada for human clinical trials in 2009. We are committed to supporting translational medicine by providing virus-vector manufacturing services to researchers who want to move forward to clinical trial testing of their product.

For further information, please contact:

Maria Fe C. Medina

Manager, Robert E.Fitzhenry Vector Laboratory

P: 905-525-9140 ext. 22946

mmedina@mcmaster.ca

 

 

 

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Facility

 

  • Cell Suite
    • ISO 5 BSC in ISO 7 Cleanroom
    • 37˚C Warm Room
    • General Laboratory Room
    • Gowning/Degowning Room
    • Materials Storage Room
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  • Vector Production Suite
    • One ISO 5 BSC in ISO 7 Virus Purification Cleanroom
    • One ISO 5 BSC in ISO 7 Vial Fill Room
    • One ISO 7 37˚C Warm Room
    • One 37˚C Unclassified Warm Room
    • Two Unclassified Cell Culture Rooms
    • General Laboratory Room
    • Gowning/Degowning Room
    • Materials Storage Room

Equipment

 

  • Five 6-foot Microzone and Nuaire Biosafety Cabinets, three of which are located inside ISO 7 cleanrooms
  • Three walk-in Honeywell temperature-controlled rooms that can be converted between 4˚C to 37˚C
  • Three Beckman Allegra benchtop centrifuges with SX4750 and GH3.8 rotors
  • One Beckman J6 MI floor centrifuge with JS4.2 rotor
  • Two Beckman Optima ultracentrifuges with two SW41 and one SW 55 rotors
  • 1 Bio-Rad NGC Quest Plus Chromatography System
  • One SpectrumLabs KrosFlo MiniKros Pilot TFF pump
  • Two Masterflex L/S peristaltic pumps with Easy-Load 3 pump head
  • One -70˚C freezers, two -20 freezers, four 2-8˚C refrigerators,
  • Seven CO2 incubators
  • Two Hach HHPC-6 particle counters, two EMD MAS-100 air samplers
  • One Locator 6 liquid nitrogen tank, one Thermo Electron Cryo Plus Liquid Nitrogen storage system
  • 24-hr continuous monitoring of temperature-controlled equipment
  • Two 50 Liter TFF bins for disposable bioreactor bags

 

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GMP Manufacturing Experience

 

  • Creation of six master virus banks and clinical lots that passed quality testing for sterility, mycoplasma, endotoxin and adventitious viruses
  • Two qualified HEK 293 master cell banks
  • Serum-free suspension cell culture in disposable, sterile, pyrogen-free, single-use plasticware
  • Grown in chemically defined media, without serum or any animal-derived product

Clinical Lots Manufactured to date: 

  • Human Adenovirus 5-based tuberculosis vaccine approved by Health Canada for use in a phase 1 trial in healthy volunteers and in a phase 1 aerosol trial
  • Human Adenovirus 5-based cancer vaccine approved by Health Canada in combination with an oncolytic virus immunotherapy
  • Human Adenovirus 5-based feline vaccine approved by Health Canada for use in a veterinary clinical trial
  • One clinical lot of Human Adenovirus 48-based canine vaccine to be used in a veterinary clinical trial
  • Chimpanzee Adenovirus C68-based tuberculosis vaccine
  • Human Adenovirus 5-based vector expressing human IFNα

Pre-clinical Manufacturing Service

  • Manufacturing of Adenovirus and VSV batches for Toxicology testing using the same quality of starting materials as for GMP manufacturing
  • Creation of new Adenoviral vectors from cloning up to virus rescue and scale-up manufacturing
  • Catalog of ready-made recombinant Adenoviruses and VSV vectors expressing various reporter genes and cytokines available for pre-clinical research applications. Orders placed per vial or custom manufacturing for larger amounts
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