Facility

therapurebio-facility

Therapure Biopharma Inc. has two cGMP facilities (biomanufacturing facility and warehouse) and both are conveniently located in the Greater Toronto Area (Mississauga) near Toronto Pearson International Airport. Whether we're receiving starting or raw materials or shipping finished product, our team, systems and convenient location minimize costs and simplify logistics.

FEATURES OF OUR 136,000 SQ. FT. (12,800 SQ. M.) cGMP BIOMANUFACTURING FACILITY

Our state-of-the-art 136,000 ft2 (12,800 m2) cGMP biomanufacturing facility was built to meet FDA (USA), HPFB (Canada), EMA (Europe) and MHRA (UK) standards. It was also designed with flexibility, versatility and scalability in mind. Located at 2585 Meadowpine Blvd. in Mississauga, it consists of the following:

  • 33,000 ft2 (3,100 m2) for administrative offices
  • 32,000 ft2 (3,000 m2) of cleanroom suites, ranging from Class A (Class 100:ISO 5) to Class D (Class 100,000:ISO 8)
    • Solvent-handling capabilities in our explosion-rated suites
  • 20,000 ft2 (1,900 m2) for utilities
  • 18,000 ft2 (1,700 m2) for the HVAC penthouse
  • 14,800 ft2 (1,400 m2) for other support areas
  • 12,200 ft2 (1,100 m2) for development and quality control and analytical labs
  • 6, 000 ft2 (600 m2) cGMP warehouse with cold storage
    • Temperature-controlled storage at +4°C and low temperature (-20°C to -80°C)
    • Fully monitored secure storage
    • Inventory-control system (unique item number traceability)
    • Segregated shipping and receiving docks
    • Explosion-rated storage
  • 10 L to 3,000 L stainless steel process tanks
  • 5 Clean-in-Place (CIP) units for process equipment
  • Water for injection (WFI) Steam-in-Place (SIP) capability
  • USP- and EP-compliant utilities: purified water system, WFI (120,000 L per day capacity), clean steam, oil-free
    compressed air
  • Central service chase, allowing independent utility changes and minimizing clean-operation downtime
  • Easy installation and maintenance of equipment through
    • Roll-up doors
    • Outside wall access panels
    • Processing area with removable cleanroom walls
  • Processing areas with dedicated, pressurized air locks
  • Negative-pressure containment area

FEATURES OF OUR 44,000 SQ. FT. (4,100 SQ. M.) cGMP WAREHOUSE AND ADMINISTRATIVE OFFICES

Located at 420 Ambassador Road in Mississauga, this facility consists of the following:

  • 30,000 ft2 (2,800 m2) cGMP warehouse with cold storage
  • 14,000 ft2 (1,300m2) administrative and other support functions
    • Ambient warehouse is temperature controlled and monitored, at +15°C to +25°C with full HVAC
    • Temperature-controlled cold storage walk-in cooler +2°C to +8°C (Setpoint 5°C)
    • Temperature-controlled walk-in freezers storage at -40°C (+/- 5°C)
    • Fully monitored secure storage
    • Inventory-control system (unique item number traceability)
    • Shipping and Receiving dock area fully segregated from storage areas

ADDITIONAL DISTRIBUTION SERVICES

  • Established and validated shipping protocols for both cold and frozen products
  • Next-day deliveries throughout North America (clinical or commercial materials)