The science of cell and gene therapy (CGT) is advancing rapidly and Toronto- based CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies, has been working on the challenge of bringing the manufacturing capabilities these therapies will need to reach patients. In March 2022, CCRM announced the launch of its subsidiary OmniaBio Inc., a preclinical to commercial-scale contract development and manufacturing organization (CDMO) focused on CGT, already in operation.
“OmniaBio is filling a gap for Canadian cell and gene therapy companies,” explains Mitchel Sivilotti, CEO of OmniaBio Inc. “In addition to offering Canadian developers commercial CGT manufacturing, which is missing in Canada, OmniaBio has been a great option for international developers looking for a CDMO with process development expertise and a laser focus on manufacturing cell and gene therapies.”
Dozens of life-saving therapies will soon graduate from development pipelines and require commercial-scale manufacturing to reach patients. According to the Alliance for Regenerative Medicine, the year ahead is set to herald regulatory decisions on as many as 13 new cell or gene therapies for use in the U.S., Europe, or both. This brings the industry closer to the FDA’s oft-cited 2019 prediction that by 2025, 10-20 new cell and gene therapies will be approved each year.
In searching for a place to nurture and launch CGTs onto the global market, international therapeutics developers will be looking for two key things: manufacturing capacity and the extensive expertise required to keep projects on time and at the quality they need.
Built upon platform leadership in induced pluripotent stem cells (iPSCs), lentiviral vectors (LVV) and immunotherapy, OmniaBio has both. The company’s extensive expertise builds on CCRM’s established reputation in process development and manufacturing for CGTs.
The Hamilton, Ontario, location of OmniaBio’s Phase III and commercial facilities ticks many boxes. It ensures easy access to Toronto’s biotechnology cluster that includes world-leading research hospitals and the globally-ranked University of Toronto, provides proximity to the U.S. border – less than a one- hour drive away – and builds on Hamilton’s proud manufacturing history and skilled workforce, with graduates from McMaster University and Mohawk College to provide talent. Hamilton is also home to an international airport that is Canada’s largest for air cargo – a big advantage when shipping fragile medical products to the global market.
The new facility will open in a phased launch between 2024 and 2026, and was enabled by a CAD$40 million loan from the Government of Ontario via the Invest Ontario fund. OmniaBio also has $60 million in private investment from strategic partner Medipost, a South Korean player in cell therapy.
OmniaBio has also attracted funding from Next Generation Manufacturing Canada (NGen). In September 2022, the industry-led organization behind Canada’s Global Innovation Cluster for Advanced Manufacturing announced it had made a $10.5 million contribution to a $34.8 million project led by OmniaBio, with partners Aspect Biosystems, ExCellThera, Morphocell Technologies and the Canadian Advanced Therapies Training Institute. The project will deliver against three core objectives, one being a mandate to train Canada’s future biomanufacturing workforce.
OmniaBio will be the anchor tenant of a new biomanufacturing campus at Hamilton’s McMaster Innovation Park (MIP). MIP will bolster Ontario’s life sciences cluster, creating a campus that brings together biotech firms, suppliers and the specialized support and logistics services they will need to reach international markets. Everything that international therapeutics developers could conceivably need will be in place, right here in Ontario, enabling developers to nurture, produce-at-scale, and distribute a new CGT to health systems – and ultimately patients – around the world.
Learn how OmniaBio can support therapeutics developers at omniabio.com.
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