OmniaBio Announces Opening of New Commercial Manufacturing Facility in Canada, Bringing Life-Saving Cell and Gene Therapies to Patients

The site will add state-of-the-art CGT capacity and employ artificial intelligence and automation to achieve critical product supply efficiencies for North American and global biotherapy clients

HAMILTON, ON, Oct. 17, 2024 /PRNewswire/ - Today OmniaBio Inc. will announce the opening of a new North American cell and gene therapy (CGT) manufacturing and artificial intelligence (AI) centre of excellence, which is now Canada's largest contract development and manufacturing organization (CDMO) facility dedicated to CGT. Based in Hamilton, Ontario, the facility is a groundbreaking development for both the Canadian biotech industry and the broader global market.

This commercial-ready facility will enhance the manufacturing of these transformative therapies, further establishing Canada as a hub for innovation, while increasing access and affordability to advanced medical treatments across North America. Initially founded by Canada's Centre for Commercialization of Regenerative Medicine (CCRM) and later joined, in partnership, by MEDIPOST, Co., Ltd., OmniaBio deploys over a decade of manufacturing and analytical technology expertise, developed through Canadian, U.S. and international partnerships.

OmniaBio will collaborate with pharmaceutical and biotech companies and academic centres to deliver comprehensive services from process, analytical and associated AI development to commercial manufacturing.

The new facility's first commercial-stage customer, MEDIPOST, is a recognized innovator in stem cell therapeutics and has plans to manufacture CARTISTEM^® at OmniaBio's Hamilton site for North American patients. CARTISTEM is an allogeneic (sourced from donor cells) umbilical cord blood-derived mesenchymal stem cell product used to treat knee cartilage defects in patients with osteoarthritis caused by degeneration.

The new 120,000 sq. ft. site, located at McMaster Innovation Park and in close proximity to the U.S. border and Canada's largest international airport, is designed to meet specialized needs such as critical cold chain logistics, dedicated staff training infrastructure, intelligently designed production flows, and a multi-modality layout facilitating both cell and vector-focused manufacturing. Using advanced technologies such as robotics, biosensors and machine learning, OmniaBio will be among the first CDMOs globally to integrate these capabilities into its service offering, helping to reduce costs, improve product quality and increase production rates compared to conventional CDMO approaches. OmniaBio's AI-enabled manufacturing will first focus on cellular immunotherapies and iPSC-based therapies.

Quotes:

"I'm thrilled to celebrate the grand opening of OmniaBio's new centre of excellence in Hamilton, which will help create good-paying jobs for Ontario workers and cement our province's role as a world leader in life sciences. This new centre, which our government was proud to support through Invest Ontario, highlights the substantial increase in jobs and investment we've seen in Ontario's life sciences sector and points to the incredible opportunity this sector holds for our province's long-term prosperity."

     -      Hon. Doug Ford, Premier of Ontario

"With a highly-skilled workforce and competitive business environment, Ontario is a prime location for businesses in the life sciences sector to invest and grow. We congratulate OmniaBio on this exciting milestone and look forward to seeing their facility drive further advancements across the province's life sciences ecosystem."

     -      Hon. Vic Fedeli, Minister of Economic Development, Job Creation and Trade

"OmniaBio is partnering with clients to make these essential therapies more accessible and affordable for patients in North America and worldwide. This new facility puts us in a unique position as a specialist commercial CGT manufacturing leader tackling the toughest disease challenges head-on by combining an experienced team with advanced tools and solutions."

     -      Mitchel Sivilotti, President and CEO, OmniaBio Inc.

"The opening of OmniaBio's facility in Hamilton is an exciting milestone in CCRM's efforts to build a strong industry in Canada around its strengths in regenerative medicine, including cell and gene therapy. This facility is a game-changer as it will keep revolutionary companies in Canada and attract global leaders to our ecosystem. With manufacturing, we have the ingredients to see the ecosystem thrive."

     -      Michael May, President and CEO of CCRM and Chair of OmniaBio's Board

"For two decades, MEDIPOST has been advancing cord blood stem cell therapies from basic science to successful commercialization. As demonstrated by the recent complete enrollment of our Phase III CARTISTEM trial in Japan and our plan for a Phase III trial in the U.S. MEDIPOST is fast becoming a global company, and our investment in OmniaBio is an investment in this future and in the people of Ontario who will help bring this vision to fruition."

     -      Antonio Lee, Global President, MEDIPOST, Co. Ltd. & Co-CEO and Director, MEDIPOST Inc.

"The opening of OmniaBio's Hamilton site is the result of the vision, determination, and collaboration of many dedicated people from across the globe. As the first client at this site, MEDIPOST looks forward to harnessing OmniaBio's world-class expertise and manufacturing capabilities to bring our stem cell therapy, CARTISTEM, to North America."

     -      Edward Ahn, CEO, MEDIPOST, Inc. (USA)

About OmniaBio

OmniaBio Inc. is a technology-focused, global cell and gene therapy CDMO with a vision to manufacture a disease-free world. As a subsidiary of CCRM, OmniaBio harnesses over a decade of expertise in regenerative medicine and advanced therapies. Offering comprehensive and tailored CDMO services, cutting-edge development and reliable Good Manufacturing Practices capabilities, OmniaBio specializes in immune cell-based therapies, induced pluripotent stem cell therapies and lentiviral vectors, driving advancements in the field and bringing maturity to cell and gene therapy. With existing clinical and commercial manufacturing capabilities OmniaBio is poised to meet surging global CGT manufacturing demand, enabling access to transformative treatments for patients around the world. Please visit us at www.omniabio.com to learn more.

About CCRM

CCRM is a global, public-private partnership headquartered in Canada. It has received funding from the Government of Canada, the Province of Ontario, and leading academic and industry partners. CCRM supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, investors, and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients with specialized teams, dedicated funding, and unique infrastructure. In 2022, CCRM established OmniaBio Inc., a commercial-stage CDMO for manufacturing cell and gene therapies. CCRM is hosted by the University of Toronto. Visit us at ccrm.ca.

About MEDIPOST

Founded in 2000, MEDIPOST is a leading commercial-stage biotechnology company specializing in the development of umbilical cord-derived stem cell therapies to treat inflammation-driven degenerative diseases. The company's flagship product, CARTISTEM^®, is the world's first allogeneic stem cell therapy for knee osteoarthritis (OA), approved in Korea in 2012 and used to treat over 31,000 patients. As the largest and most trusted umbilical cord blood bank in Korea, MEDIPOST leverages its deep expertise in stem cell research and development to pioneer innovative treatments that improve patient outcomes. In partnership with the Centre for Commercialization of Regenerative Medicine (CCRM), MEDIPOST has established Omniabio, a cell and gene therapy contract development and manufacturing organization (CDMO) based in Hamilton, Ontario. With a focus on global expansion, MEDIPOST is advancing its therapies into the Japanese, U.S. and European markets through ongoing Phase III clinical programs.

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SOURCE OmniaBio Inc.