University researchers and drug developers in Edmonton are joining forces to create what they say will be the first facility in Canada that can bring the latest scientific pharmaceutical knowledge from the laboratory through clinical trials to market.
The partnership, announced Monday, brings together a leading global laboratory and an existing drug manufacturer to plug a hole in Canada’s drug supply system, said Andrew MacIsaac of Applied pharmaceutical innovation, the nonprofit corporation involved in the effort.
“This is the first large-scale union of what API is doing and what researchers at a postsecondary institution are doing,” he said.
The MacIsaac firm, which currently employs about 40 scientists at its Edmonton facility, is partnering with the renowned Li Ka Shing Institute of Virology at the University of Alberta to form the Canadian Critical Drugs Initiative.
“This was a good marriage for both of us,” said Lorne Tyrrell, co-director of the institute and discoverer of the first oral treatment for hepatitis B.
Canada currently lacks the capacity to manufacture its own drug supply, a gap that became apparent when the federal government was trying to block supplies of the COVID-19 vaccine.
Since then, the federal government has funded specific research and manufacturing facilities in Montreal, Winnipeg, and Saskatoon.
But Alberta’s effort would be unique in linking the lab bench and the pharmacy shelf, as well as the type and breadth of drugs it would help develop.
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Michael Houghton, the institute’s other director and Nobel laureate, said the initiative would focus on so-called “small molecule” drugs, chemically synthesized drugs that make up the vast majority of what is in people’s medicine cabinets. Ibuprofen, for example, is a small molecule drug.
“What we’re trying to do at the institute is develop novel vaccines, novel therapies, and novel drug detection tools.”
“We have a pipeline that will fit very well with the API infrastructure,” Houghton added.
Academic labs do the initial research, taking a novel drug to a proof-of-concept stage in a laboratory, MacIsaac said.
The institute can recreate that work under conditions that meet regulatory standards, conduct further studies on how the drug will behave in the body and how it should be formulated. You can then manufacture it for clinical trials.
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The Canadian Critical Drugs Initiative will unite both parties, MacIsaac said. It will also improve the supply chain of existing drugs, such as propofol, which is commonly used to induce unconsciousness in procedures from surgery to ventilator placement.
“It was often in short supply before COVID-19, then COVID-19 exacerbated that.
“Having a strong supply chain for that drug is critical.”
MacIsaac’s company now manufactures drugs in quantities appropriate for clinical trials – a few thousand doses a month. Part of the goal of the new association is to increase that.
“We will be able to produce around 70 million doses of drugs a year, a wide variety from the security of supply of basic drugs that are needed in the hospital environment to novel drugs that are coming out of institutes like Li Ka Shing,” he said. said. That will require some expansion.
The initiative seeks to expand its facilities at the University of Alberta and the Alberta Research Park in Edmonton. A 40,000-square-foot manufacturing facility is also planned.
The entire project will cost around $ 169 million. Private investors, as well as municipal and provincial governments, are on board and about half of the money has been raised. A request for funding has been sent to Ottawa.
MacIsaac said the initiative could produce drugs in two years. It is an economic opportunity for a province seeking to diversify, he said.
“It will create hundreds of jobs in the short term and many, many more in the long term. We will be able to find a home for many of the talents that we have developed in the oil and gas industry. “
The initiative could help create a group of companies to add to the hundreds of drug manufacturing jobs already in Edmonton, he said.
Edmonton scientists are already waiting to go ahead with clinical trials of vaccines against flagella, such as hepatitis C, or viruses that threaten transplant patients, Houghton said.
One way to bring those advances to market is the missing piece of the puzzle.
“We have a future pipeline,” he said.
“We are going to need the infrastructure of the Canadian Critical Drugs Initiative to finish and help us manufacture these vaccines for clinical trials and deliver these vaccines.”
© 2021 The Canadian Press
Reference-globalnews.ca