Facility Description
Cell Suite
- ISO 5 BSC in ISO 7 Cleanroom
- 37ºC Warm Room
- General Laboratory Room
- Gowning/Degowning Room
- Materials Storage Room
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 37ºC Warm Room
- One 37ºC 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 4ºC to 37ºC
- 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 -70ºC freezers, two -20 freezers, four 2-8ºC 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
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 IFN?
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