Front view of the Biologics Manufacturing Centre in Montreal
June 2021

Construction Completed

  • Full end-to-end manufacturing capabilities
  • Good Manufacturing Practices (GMP)-compliant
  • Tech transfer of client vaccine process ongoing

The Building

  • 58,000 sq. ft on 2 Floors
  • 12,500 sq. ft of manufacturing space
  • 2 individual production suites (500L/2,000L)
  • Quality control laboratory
  • Warehouse
  • Mechanical area
  • Offices and common spaces

Production Equipment

  • 250+ pieces of equipment
  • Bioreactors (2,000L/500L)
  • Buffer and media preparation (multiple vessels up to 1,000L)
  • Chromatography columns
  • Tangential flow filtration
  • Aseptic flow equipment
  • Secondary packaging line (future)
  • Autoclaves (decontamination and sterilization)
  • Parts washer

Infrastructure & Services

  • 30 critical interdependent systems
  • GMP-compliant Control and Data Management Systems
  • Purified water
  • Water for injection
  • Pure stream
  • Effluent treatment system
  • 12 HVAC units
  • Clean compressed air and gases
  • Chilled water
  • Cell and viral seed storage

Offering full end-to-end manufacturing capabilities

The Biologics Manufacturing Centre’s two-level building facility with a total area of approximately 54 900 square feet (ft2), is equipped with end-to-end production capability for vaccines and cell-based biopharmaceuticals from mammalian and insect cell cultures for human use.

It has the production capacity for drug substance, fill-finishing, visual inspection, labelling, packaging, and warehousing, including testing.
The HVAC systems are designed to control the filtration for airborne particulate and microbial bioburden based on GMP requirements, and biosafety containment level requisites.

The BMC is designed to treat the local supply of potable water to produce purified water (PW) meeting current USP and EP monographs. The PW feeds the Water for Injection (WFI) system meeting the current USP and EP monograph with a production capacity of 1200 LPH.

There are no cytotoxic, highly potent or sensitizing agents handled on site.

Production Suites


The upstream biomanufacturing process is the initial stage of the production where cells are gradually expanded from flasks to bioreactors. Initial cell culture manipulations are performed by Technologists in biosafety cabinets (BSC) and then, transferred to bioreactors.

The BMC bioreactor capacity totals 2,500 litres with one train up to 2000L and a second train up to 500L and supporting expansion bioreactors of 50L and 200L with flexibility embedded into its physical config- uration for future increase in production capacity.

Harvesting the product is performed through centrifugation and filtration, followed by clarification steps to further harvest the cell lysate or broth to remove any remaining cellular debris or particles.

Upstream bio-manufacturing process in the facility's 2,500 litre bioreactors.
BMC's tangential flow filtration chromatography columns for product recovery and purification.


The downstream process involves the isolation of the desired product.

The specific methods and equipment used can vary depending on the nature of the cells, the product, and the process requirements.

Product recovery and purification steps can be performed through tangential flow filtration (ultrafiltra- tion/diafiltration / buffer exchange) chromatography columns, and/or steps to concentrate and purify the product. The equipment train can be tailored to suit your process and scale requirements for opti- mizing the yield, purity, and quality of your product.

Fill & Finish and Secondary Packaging

Once the bulk drug substance has been manufactured, it is transported to the filling suite, where it is formulated and filled into sterile vials using specialized filling equipment.

For glass vial filling BMC uses a closed isolator equipment from VanRx and container volumes can range from 2mL to 10mL.

Each vial is then carefully inspected in inspection booths, then labeled and packaged in their desired packaging format in the packaging area, and finally stored in the warehouse, in temperature-controlled areas as per required specifications, until they can be shipped to their next destination.

BMC uses a closed isolator equipment for filing glass vials of 2 to 10 ml.

Quality Control Laboratory

The QC department consists of 2 key groups based on their respective activities:

Analytical Laboratory

This laboratory performs chemical, physical-chemical, immunochemical, in-process, and release testing on raw materials, packaging materials, intermediates, drug substances and drug products. Its activities also include testing of stability samples, analytical method transfer activities, process and cleaning validation studies and utility monitoring. The analytical laboratory equipped with a cell culture platform for cell-based assays.

Microbiology Laboratory

This laboratory performs microbiological in-process and release testing on raw materials, packaging materials, intermediates, and drug products. Its activities also include sample testing of utilities, environmental monitoring, stability testing, analytical method & technology transfer activities, process and cleaning validation studies (e.g. microbial identification, bioburden, microbial limit, endotoxin, and sterility testing).


There are many systems constantly running in the background of the Biologics Manufacturing Centre to enable the vaccine production processes to run smoothly, with the absolute sterility required for good manufacturing practices (GMP) compliance, and to ensure that the end product is safe for human use. Some of these important utilities include:
GMP-compliant Control and Data Management Systems
Clean utilities - Purified water, Water for injection (WFI) and Pure steam
Biological effluent treatment system
12 HVAC units - Heating, ventilation and air-conditioning monitored by environmental monitoring system (EMS)
Clean compressed air and medical grade gases - Oxygen, Nitrogen, Carbon Dioxide
Process drainage
Emergency power generator and uninterruptible power supply (UPS)
Cell and viral seed storage
The largest ingredient in most vaccines is very pure water, this makes the water systems an important part of the equipment at the Biologics Manufacturing Centre (BMC) Inc.
Bio-processing equipment to ensure a smooth running vaccine production.
Three blue shipping doors allowing access to the 8,400 sq. ft. warehouse facility.

Supply Chain & Warehouse

The 8,400 square foot warehouse within the BMC, is used to receive and store all the consumables and raw materials required to both maintain the facility in a continuous GMP readiness state and support client production.

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