Omniabio: Road to Canada’s largest cell and gene therapy CDMO

New biomanufacturing facility in Hamilton helps take Ontario-made transformative therapies to the market

At the frontier of biomedical innovation, cell and gene therapies (CGTs) hold the promise to revolutionize the treatment of a broad range of life-threatening diseases such as cancer, autoimmune diseases, neurological disorders, and numerous genetic conditions.

While having the potential to transform lives and healthcare, fewer than a hundred CGTs had been approved for clinical use globally by the end of 2023.

However, traction has been growing in recent years through new technical advances alongside the maturation of clinical trials in indications where CGTs have found their niche. The notable clinical pipeline is an indicator that the industry could experience explosive growth in the near future.

Or as Mitchel Sivilotti, CEO of OmniaBio Inc., put it, “CGT is now an established pillar of medicine, and we can point to recent commercial successes like CAR T-cell therapies to provide the momentum for the next wave of innovation for the developers and patients we serve.”

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New facility opened in October 2024

A subsidiary of the Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM), OmniaBio is Canada’s largest commercial-scale contract development and manufacturing organization (CDMO) dedicated to CGTs.

With the support of Invest Ontario, OmniaBio has built a new biomanufacturing facility in Hamilton, Ontario with an overall project investment of over $580 million, creating 250 skilled jobs. Launched in October 2024, it is the largest facility of its kind in Canada.

By providing the missing infrastructure in biomanufacturing, OmniaBio will help CGT companies in Ontario – and from around the world – take their innovations to the global marketplace and capitalize on emerging opportunities, while bolstering Ontario’s presence in the global life sciences sector.

Bridging the commercialization gap

Since the discovery of stem cells by Ontario scientists in the 1960s, the province has emerged as a leader in life sciences research and development.

Boasting Canada’s largest life sciences ecosystem with close to 2,000 firms, Ontario is home to a concentration of multinational pharmaceuticals and pure-play startups focused on making breakthroughs in innovative therapeutics like CGTs.

However, the development and commercialization of CGTs face unique hurdles not seen in the conventional drug space. These include steeper regulatory, supply chain, and patient access challenges stemming from the inherent technical complexity, variability, and high costs of the technology. Throughout the cycle, the problem often comes down to manufacturing expertise and capacity.

This is where OmniaBio steps in – and why it came into existence in the first place.

“CGT companies often turn to CDMOs to outsource the highly specialized function of manufacturing these life-saving medicines,” said Sivilotti. “OmniaBio is ideally positioned to help meet this need.”

Adding to its existing development and clinical manufacturing capabilities in Toronto, OmniaBio’s new facility in Hamilton will round out the company’s strategy to provide end-to-end services from preclinical process development and analytics to commercial supply in three key manufacturing platforms: induced pluripotent stem cell-based therapies, immune cell-based therapies, and lentiviral vectors.

The company is also focused on manufacturing innovation, especially artificial intelligence and automation to optimize production, quality control, and supply chain activities to reduce cost and increase quality and throughput.

“As an industry, we’re starting to harness the power of data and robotics to bring manufacturing efficiency to new levels, which will ultimately translate into improved patient access through lower costs,” Sivilotti added.

Ontario: an enabler of growth and innovation

Like every life sciences company in Ontario, OmniaBio benefits from access to a reliable source of highly skilled human capital (including over 70,000 STEM graduates every year) thanks to the province’s rich pool of talent coming from a network of world-class universities, colleges, and research and medical centres.

Aside from talent, this dynamic ecosystem has enabled OmniaBio to build strong partnerships with leading equipment manufacturers, supply chain alliances, and therapy developers.

Sivilotti also stressed the importance of the government’s role in fostering a business environment that promotes growth and innovation.

This means a forward-looking vision like Ontario’s life sciences strategy, which aims to establish the province as a global biomanufacturing and life sciences hub. This also means having enabling policies and incentives in place, and government agencies such as Invest Ontario dedicated to supporting high-impact investments like OmniaBio’s.

“Simply put, Ontario has the appetite to support and grow CGT companies,” said Sivilotti.

In addition to providing a loan of up to $40 million through the Invest Ontario Fund to support OmniaBio’s project, Invest Ontario has helped raise awareness of the company among the industry and ecosystem, promoting local partnership opportunities.

Invest Ontario’s support of OmniaBio has helped make our new biomanufacturing facility a reality. They worked with us on an innovative partnership to ensure OmniaBio’s extended impact would directly enrich the biotech and biomanufacturing ecosystems in Ontario and Canada. Invest Ontario has been a positive partner and we’re grateful for their ongoing support.

Mitchel Sivilotti

CEO, OmniaBio Inc.

OmniaBio is collaborating with the Canadian Advanced Therapies Training Institute (CATTI), established by CCRM and Montreal-based CellCAN, to build a comprehensive training system to upskill and maintain their Good Manufacturing Practices (GMP) workforce.

A “pivotal” moment

It’s an exciting time to be in the CGT industry, according to Sivilotti.

Over the past decade, only select CGTs have been approved for use by North American regulatory bodies. Now, Sivilotti is witnessing a growing number of CGT companies innovating and running clinical trials, which will lead to more commercial approvals and patients treated.

“On a societal level, CGTs are only beginning to enter the mainstream consciousness. It’s a pivotal time to tell the story of regenerative medicine and the incredible impact it will have on patients’ lives around the world,” he commented.

Once the project in Hamilton is completed, OmniaBio will begin to evaluate additional expansion plans in new geographies.