Innovators and researchers will have a new path to developing new drugs with the Canadian Critical Drug Initiative. As we add new production and manufacturing facilities API will offer support for all phases of commercialization, including clinical trials.
The Covid 19 pandemic made clear how fragile the global supply chains for critical drugs are, and Canada’s lack of capacity to develop new drugs here. But help is now on the way when it comes to developing new small-molecule therapeutics in Canada and manufacturing them here. It is the Canadian Critical Drug Initiative, or CCDI.
Up until now, the development of new drugs in Canada has been hindered by a lack of manufacturing capacity for small-molecule ingredients and injectable finished products. And that means limited opportunity for innovators to commercialize within the country.
That is where CCDI comes in. It’s a revolutionary initiative led by Applied Pharmaceutical Innovation (API), which was founded in 2017 as an industry-led, not- for- profit organization.
API’s role
“We launched API with the goal of better supporting the growth of the life sciences sector here in Alberta and Canada. The big challenge that we were looking to address was the disconnect between academic research and the needs of industry,” said Andrew MacIsaac, CEO of API.
API helps innovators move potential medicines of the future from early-stage research to something that is approved and on the market. Commercializing new drugs can be difficult. There’s a ten year runway, sometimes a twenty year runway, from when something is first discovered to when it’s actually an approved treatment.
“There’s a lot of work, time, and risk taking between its discovery and that drug becoming a treatment. We maximize the chances of that discovery making it to market,” said MacIsaac. “We offer our 45 staff and one hundred affiliated experts – these aren’t just scientists but also people who thoroughly understand things like regulations, gathering data, and reporting.”
Ottawa steps in to help
With Ottawa’s support for the CCDI, and the previous support from the Government of Alberta, API’s ability to help innovators will be greatly enhanced as it will expand support for Phase III clinical trials.
The project received $80.5 million in funding from The Government of Canada. 20 million dollars of the federal money is going towards commercialization work at the Li Ka Shing Applied Virology Institute at the University of Alberta, and the remaining $60 million goes to adding much-needed infrastructure for producing and manufacturing drugs.
New manufacturing facility
Specifically, the infrastructure being added includes a new 40,000 square foot manufacturing facility. It will be able to produce 200 litre batch sizes of small-molecule active pharmaceutical ingredients, and it will have a sterile/aseptic fill/finish facility capable of producing 70 million doses a year.
What’s more, it will have a multipurpose robotic filling line able to produce three thousand vials per hour, ranging from 1ml to 100ml, both liquid and powder, a rotating autoclave for emulsion products, two to four suites for API manufacturing, cold storage, and a flash freezer that can handle RNA vaccines. The anticipated opening of the new manufacturing facility is 2026.
In the meantime, so that CCDI can hit the ground running, there will be upgrades to the 72,000 square foot Biotechnology Business Development Centre at the Edmonton Research Park to include an additional Good Laboratory Practice lab, core facilities, and improvements to enable the incubation of life science scale-up companies.
API CEO grateful
MacIsaac is really pleased. “Investments in capacity related to the pandemic have focussed predominantly on vaccines and there hasn’t been investment in small molecule manufacturing despite the fact that it makes up 80 to 90 per cent of the drugs that are in the health care system. This investment in capacity is critical for Canada’s resiliency when it comes to these drug shortages.”
MacIsaac said the manufacturing facility will not only help create new drugs, but will address these shortages of drugs that are currently in short supply. “Even prior to Covid 19 there had been shortages and they have had to delay surgeries because they don’t have medication on hand. Having this local production will be a great benefit to the health care system. Not only in times of crises or pandemics but also just in terms of improving resiliency and efficiency.”