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Vaccine makers, medical researchers and pharmaceutical companies now have a new full-service option to get their products manufactured in Canada, thanks to a partnership announced this week.

The U of A’s Alberta Cell Therapy Manufacturing (ACTM) facility has signed a memorandum of understanding with The Ottawa Hospital’s Biotherapeutics Manufacturing Centre (BMC) and BioCanRx, a Canada-wide research network to develop cancer therapies.

The partners already collaborate to manufacture several products, including a gene therapy for a deadly lipid disorder, therapeutic cells used to treat septic shock, and the Entos Pharmaceuticals COVID-19 vaccine, which has just been approved for Phase 2 human clinical trials.

Greg Korbutt

Greg Korbutt

“For Canada to play a key role in new breakthrough therapies and vaccines, we must invest in multiple facilities across the country and foster collaboration,” said Greg Korbutt, professor of surgery in the Faculty of Medicine & Dentistry and ACTM scientific director. “This agreement sets the stage for a Canadian biomanufacturing ecosystem.”

“Canada has some of the best scientific minds in the world working to develop new therapies and vaccines, but they have been limited by our lack of domestic biomanufacturing capacity,” said Duncan Stewart, executive vice-president of research at The Ottawa Hospital and professor of cellular and molecular medicine at the University of Ottawa. “This new partnership, which combines areas of strength across the country, will greatly enhance Canada’s ability to produce medical treatments and vaccines.”

Duncan Stewart

Duncan Stewart

“Canada has deep biopharma research experience, so it’s great to see expansion in the biomanufacturing sector. Hopefully, Canada continues to invest in initiatives such as this,” said John Lewis, who is the Frank and Carla Sojonky Chair in Prostate Cancer Research at the U of A, a member of the Cancer Research Institute of Northern Alberta and CEO of vaccine developer Entos. “Accessing the facilities and expertise at ACTM and The Ottawa Hospital has significantly helped propel our COVID-19 vaccine candidate into clinical trials.”

The ACTM facility contains six clean rooms, a quality control lab and a soon-to-be-completed fill-finish suite, where medications are bottled and sealed for shipment. The staff and equipment meet Good Manufacturing Practice (GMP) regulatory requirements. The facility was completed in 2014 with $26.2 million from the Canada Foundation for InnovationAlberta Enterprise and Advanced Education and the University of Alberta.

Korbutt was part of the original team that developed the Edmonton Protocol, transplanting donor islet cells into people with Type 1 diabetes, and ACTM will be involved with future islet stem cell research. ACTM is also producing chimeric antigen receptor (CAR) T-cells for use in an innovative treatment now in clinical trials that uses a patient’s own immune system to battle cancer cells.

Korbutt explained that the goal is to automate the fill-finish process, expanding the current capacity of 1,000 vials per day to 5,000. The new partnership will help ACTM reach new clients and markets, and expand its revenue stream.

“The waiting period for fill-finish in the U.S. can be several months,” said Korbutt. “Any pharmaceutical company making a liquid drug that needs to be fill-finished is a potential customer. Our facility is state-of-the-art.”

“This partnership will not only scale up our domestic biomanufacturing capacity, but include hands-on GMP training to meet the astounding demand for biomanufacturing personnel,” said Stéphanie Michaud, president and CEO of BioCanRx. “More importantly, it serves to support our made-in-Canada approach focused on expanding access to clinical trials for potentially life-saving cancer treatments.”

Korbutt said the partnership represents a significant expansion of Canadian biomanufacturing capacity, assuring a reliable and cost-effective domestic supply of vaccines and other medicines for Albertans and Canadians.

“Canada had lost most of its biomanufacturing prior to the COVID-19 pandemic,” Korbutt noted. “This could be one important piece in the process of rebuilding.”

| By Gillian Rutherford

This article was submitted by the University of Alberta’s Folio online magazine. The University of Alberta is a Troy Media Editorial Content Provider Partner.

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