Sponsored article provided by CCRM
Globally, the race is on to bring facilities online that can provide dedicated cell and gene therapy (CGT) manufacturing services in time for life-saving therapies that will soon need Phase III clinical and commercial-scale manufacturing to reach patients.
According to the Alliance for Regenerative Medicine’s H1 2022 report, 2093 clinical trials were ongoing at the end of June 2022, and regulatory decisions are expected for 15 therapies in 2023. The future of medicine is approaching, and it will require highly specialized, high-volume CGT manufacturing.
The need for this soon-to-be critically important biomanufacturing capacity has long been on the radar of executives at CCRM, who have been working on the challenge for years. CCRM revealed the fruits of this labour in March 2022, announcing the launch of OmniaBio Inc., a new contract development and manufacturing organization (CDMO) spin-off that will provide focused, commercial-scale manufacturing services to CGT developers around the world.
Built upon platform leadership in induced pluripotent stem cells (iPSCs), lentiviral vectors (LVV) and immunotherapy, OmniaBio is preparing for this future today. The company’s extensive expertise is building on CCRM’s established foundation and reputation in process development and manufacturing for CGTs, expanding on a team and legacy that has been built over a decade.
With scientists experienced in generating and characterizing over 200 iPSC lines, and GMP-compliant reprogramming platforms to produce therapeutic-grade iPSC lines, OmniaBio’s process development and GMP CDMO services are already operational. This offering is set to expand, with construction underway for a new facility in Hamilton, Ontario, enabling OmniaBio to offer their focused CGT manufacturing services at the Phase III and commercial scale – something developers around the world will need in short order.
The Hamilton facility, which will open in a phased launch between 2024 and 2026, was enabled by CAD$40 million in support from the government via the Invest Ontario fund. OmniaBio has also announced $60 million in private investment from Medipost, a South Korean player in cell therapy. This initial financing contributes to an overall project worth $580 million, supporting operations, construction and fit out for OmniaBio.
The added value OmniaBio will bring to the global CGT ecosystem doesn’t stop there: it will also play a key leadership role in positioning Canada as a global leader in CGT biomanufacturing.
In September, Next Generation Manufacturing Canada (NGen), 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. This is one of NGen’s largest investments to date and aims to secure Canada’s leadership in life sciences through CGT manufacturing by delivering against three core objectives: building domestic expertise and world-leading manufacturing capabilities; empowering a pipeline of Canadian-based CGT companies; and, training Canada’s future biomanufacturing workforce.
“Canada is recognized around the world as a leader in the field of life sciences,” said Jayson Myers, CEO, NGen, in a joint NGen-OmniaBio press release announcing the project. “This investment in critical biomanufacturing infrastructure ensures that we will be able to leverage our strengths in research and technology, build a work-ready talent pipeline, and provide the right conditions for our domestic CGT ventures to scale-up in Canada.”
The project consortium, with Montreal-based Morphocell Technologies, ExCellThera, the Canadian Advanced Therapies Training Institute (CATTI), and Vancouver-based Aspect Biosystems, will demonstrate to the world that Canada is an ideal location for CGT ventures to be based. OmniaBio will achieve this by developing world-leading platform technologies focused on automated and closed-system manufacturing, quality management systems, analytics and regulatory compliance.
Announcing the NGen investment back in September 2022, François-Philippe Champagne, Minister of Innovation, Science and Industry noted that: “This new $34 million project will not only solidify Canada’s leadership but also help train more Canadians for these good, well-paying jobs. This new project, led by OmniaBio and its consortium partners, will make a real difference here at home and around the world,” he added.
The training component of the NGen project will be spearheaded by CATTI, a partnership between Montreal’s CellCAN and CCRM. CATTI will lead in developing and scaling e-learning and on-site cGMP training programs that will facilitate an unprecedented capacity in Canada for efficient and rapid upskilling of the workforce for CGT biomanufacturing. OmniaBio is one of CATTI’s first major clients, co-developing a training course with CATTI to meet the needs of its rapidly growing workforce, which is projected to reach over 1,000 in the coming years.
All of this gives cause for optimism. The CGT biomanufacturing ecosystem is strengthening, at a time when international therapeutics developers will be scoping out the best places to manufacture their technologies with seamless access to north American and international markets.
The Hamilton, Ontario, location of OmniaBio’s upcoming facility ticks many boxes, such as easy access to Toronto’s biotechnology cluster that includes world-leading research hospitals and the globally ranked University of Toronto, as well as access to the U.S. border, which is less than a one-hour drive away. Not to mention Hamilton has a proud manufacturing history, a skilled workforce and graduates from McMaster University and Mohawk College to provide talent, and an international airport that is Canada’s largest for air cargo – an advantage when shipping fragile medical products to the global market.
Leaders at CCRM have demonstrated significant foresight through their efforts to bring OmniaBio online, and the Government of Ontario recognized the merit of this effort via the loan that launched the project. Ontario is preparing to take a leading position in this new global industry, providing the manufacturing infrastructure CGTs will need and capitalizing on the province’s strong foundation of industry and scientific expertise.
The new OmniaBio facility will add a fourfold increase to CCRM’s biomanufacturing capacity. The addition of OmniaBio to Ontario’s life sciences cluster will ensure that everything a new therapeutic technology could conceivably need, to be nurtured and supported along the journey from the bench to patient bedsides, is in place.
Learn how OmniaBio can support therapeutics developers at omniabio.com, and keep abreast of the latest developments by signing up to the OmniaBio mailing list.