Folio Coverage of API’s manufacturing scale-up for COVID-19 drugs

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Below is an article that appeared in the Folio the week of May 11th, covering API’s work to develop increased Canadian-drug production.

https://www.folio.ca/u-of-a-pharmaceutical-institute-leads-effort-to-fill-looming-hospital-drug-shortage/

By MICHAEL BROWN

A University of Alberta-initiated institute is leading a provincewide effort to fill the looming shortage of drugs that are vital in the fight against COVID-19.

Applied Pharmaceutical Innovation (API)—a not-for-profit institute housed within the Faculty of Pharmacy and Pharmaceutical Sciences to help commercialize pharmaceuticals—is co-ordinating labs across the Edmonton region to manufacture the drugs needed to put people on a ventilator.

“It’s an emerging issue that in the longer term will likely overtake the lack of ventilators and personal protective equipment as the primary barrier to caring for patients,” said Andrew MacIsaac, API CEO and assistant dean in the faculty. 

“The shortage of these drugs is expected to continue over the next two years as COVID-19 wreaks havoc on typical supply and demand, and will be further compounded with the resumption of backlogged surgeries and other procedures.”

He said the two drugs API is focused on right now are propofol, an anesthetic, and cisatracurium, a muscle relaxant, that together are taken via IV by someone about to be put on a respirator.

“The primary one of the two is propofol, since it is more critical and shortages of it will affect much more than just COVID-19 patients as it is the drug for sedating someone in hospital for surgery,” said MacIsaac.

Market opportunity

He explained these drugs, which are largely manufactured overseas, have become scarce thanks to exponential ventilator demand and a collapsing supply chain.

“This crisis really drove home the need for Canadian-based manufacturing, but we’ve been flagging this gap for a long time,” said MacIsaac.

He said much of the blueprint outlining the creation of API over a year ago was to take advantage of the province’s, and particularly Edmonton’s, petrochemical expertise to create a pharmaceutical stronghold in Canada.

The pharmaceutical industry is a natural fit for Alberta because a lot of the expertise the province has in the oil and gas sector easily translates to drug development, for a number of reasons, he said. 

One reason is that the initial ingredients in many pharmaceuticals are petrochemicals and, just as important, because Alberta has been an oil and gas region for so long and the U of A conducts research in the area, it provides graduates from chemistry and chemical engineering with the broad understanding of the processes and concepts that can be used in any sort of chemical manufacturing.

“What we’ve been working to do, especially as Alberta looks to diversify the economy, is show that drug development and manufacturing is something that the U of A and Edmonton have a lot of strength in already,” he said.

MacIsaac said that, along with Alberta Health Services and Health Canada, API is identifying drug shortages that will come as a result of COVID-19 and proactively building manufacturing in Alberta based on facilities at the U of A and a number of small companies in the Edmonton region.

“Alone we don’t have the capacity, but as a consortium, we’re able to pull together all the required components to manufacture drugs to meet shortages and likely provide enough of the ventilator drugs for the entire Canadian market,” he said.

Critical capacity

As for technologies developed at the U of A, MacIsaac said the current trend for researchers is to relocate to jurisdictions south of the border capable of developing drugs for initial clinical trials and then larger production.

That is set to change thanks to API and its partners, according to MacIsaac. He said the institute and its partners have built the critical capacity to take a lot of innovators in the early stages of COVID-19 research, and accelerate their programs by skipping over the time-consuming searches for capacity and investment to bring their research to the next level.

“Many researchers across all different faculties do some of the initial synthesis of the drugs that they’re researching, but they’re just prototypes of the drugs, and aren’t something that they can move forward with. Our network can produce at the level that is needed for clinical trials and beyond.

“As a result, we will be able to bring the treatments to Albertans and Canadians much more quickly.”

Besides the in-province drug production to support COVID-19 hospital patients, other COVID-19-related projects API is undertaking include developing a new antiviral drug based on past research on viruses of the same family, and launching a clinical trial for a new antiviral compound that targets more than just COVID-19 and is less toxic, and therefore easier on the immune system.