Yesterday marked a significant milestone in Canadian pharmaceutical manufacturing as our team at API breaks ground for the Critical Medicines Production Centre (CMPC) in the Edmonton Research Park. This 83,431-square-foot manufacturing facility will be a cornerstone for our nearly $200 million Canadian Critical Drug Initiative (CCDI), which is led in partnership with the University of Alberta.
The CMPC will produce vital hospital drugs to mitigate market risks and stabilize supply of critical medicines for Canadians.
Expanding our level of Contract Development and Manufacturing Organization (CDMO) support, the CMPC will develop small-molecule active pharmaceutical ingredients with the capability to perform sterile, aseptic fill, and finish operations. With a steady-state capacity of 73.2 million doses per annum, and a sprint capacity that can meet the demands of the entire Canadian population for a critical product within 100 days.
“The development of the CMPC will catalyze the expansion of Alberta’s biotech industry, fortifying Canada’s readiness against present and future pandemics. Additionally, it will drive the research and development of medications targeting prevalent diseases lacking preventive measures. Through these efforts, we aim to safeguard and enhance lives globally.”
– Sir Michael Houghton, Nobel Laureate & Chief Scientific Officer
One of the first products to be produced at the CMPC will be the generic drug, Propofol, a critical hospital drug with a tenuous supply chain that is frequently on the Health Canada tier three shortage lists. Used to sedate patients, Propofol is the backbone of the healthcare system, and shortages of the drug cause surgery delays and cancellations.
Alongside its portfolio of generic hospital drugs, the CMPC will serve a key role in enabling the scale-up of innovative discoveries coming from Canadian post-secondary systems and beyond, enabling new treatments to be manufactured for late-stage clinical trials locally.
Cutting-Edge Critical Drug Manufacturing Technology
The CMPC will feature a custom Sterile Filling Line capable of producing an extensive volume range from 1 ml to 100 ml. This versatility ensures we can meet various demands while complying with the latest regulatory requirements. Featuring a state-of-the-art isolator, it’s designed to adhere to updated standards, integrating seamlessly with the system that provides 100% in-situ weighing for both vials and bottles. The sterilizing process accommodates both standard formats and emulsions, offering unparalleled flexibility.
The facility’s line is able to sterilize the vials it uses, eliminating the need for costly pre-sterilized vials, and enhancing its flexibility, particularly critical during times of pandemic or shortage.
The inspection line incorporates advanced vision inspection, leak detection, and Container Closure Integrity Testing (CCIT), a newly mandated requirement, ensuring the highest quality control. The cartoner system automatically loads vials or bottles into trays, a task typically done manually with smaller systems.
Furthermore, the CMPC will feature a rotating sterilizing autoclave, one of only a few in North America, critical for the production of emulsion products such as Propofol.
Catalyzing Life Science Innovations
API has the ability to support companies through all phases of drug development, from early lead selection to phase 2 clinical research with services ranging from product development, regulatory strategy, training, biostatistical analysis, clinical trials, and more.
With the CMPC, API will be unique in its ability as an innovator support organization to produce phase 3 and commercial volumes. This will propel innovations from researchers across Alberta and Canada, resulting in the development of life-saving drugs.
“Alberta can and should be a leader in discovering and manufacturing the critical medicines that will save and improve lives. The CMPC and the broader CCDI are tremendous steps forward towards building this role. This initiative will create potentially thousands of jobs in the life sciences sector, delivering substantial benefits to Canada’s life sciences ecosystem by attracting investment, fostering job creation, and retaining intellectual property and talent within the country. More importantly, it will provide access to life saving treatments when we need them most.“
Andrew Maclsaac, Chief Executive Officer
Construction for the CMPC is set to be completed by 2026.