Manufacturing success from promise to patient.
Since opening in 2006, Boreal Biomanufacturing has honed a special expertise in helping clients bridge the “translational divide” — the gap between proof-of-concept of a new advanced therapy and its progression through early-phase cancer and complex disease clinical trials.
As part of The Ottawa Hospital, Boreal offers access to everything – the patients, the clinicians, the researchers, the manufacturing capacity, and hundreds of active clinical trials. We enable clients to connect all the dots that lead from an idea to actual trial-ready therapy.
It works because our clients’ primary goals and ours are in perfect sync: We’re all trying to get the best possible treatments or cures to individual patients, and then out to wider populations, as efficiently and effectively as possible.
For biotech innovators on the precipice of breakthroughs in advanced therapies, Boreal is the catalyst for translating cancer and rare disease innovations into living drugs tailored to first-in-human use, and beyond.
Let’s talk about how we can advance your advanced therapy together, from promise to patient.
Get StartedAt Boreal, our clients are spearheading scientific innovations rich with potential. They understand that turning those innovations into clinical-stage therapies is a complex process that requires the right expertise at every stage.
They’ve come to rely on our proven, multidisciplinary team to help them navigate the critical decisions that shape early-phase development. They’ve seen how we’ve taken pioneering foundational science and turned it into successful therapies in Canada, the U.S., Europe, and Asia. And they know we have everything a CDMO needs to make advanced therapies work on the bench, at the bedside, and in the marketplace.
Every company’s history tells a story. At Boreal, ours reflects decades of scientific innovation — from groundbreaking work in oncolytic viruses, to a pioneering cell therapy treatment for pulmonary arterial hypertension, to the launch of multiple spinout companies.
From our base in Canada, Boreal has been at the forefront of major therapeutic advances that have made an impact across North America and around the world. And we’d be excited to be part of yours in the years ahead.
Established
First Oncolytic Virus Clinical Trial Product
First Cell Therapy Clinical Trial Product
FACT Accreditation of Cell Therapy Facility
BRIF Award
Rebranded as Boreal Biomanufacturing
The challenges you, and we, take on are bigger than any one organization. That’s why Boreal prioritizes partnerships with an array of national networks to accelerate translational development and progression of advanced therapies, including BioCanRx, Stem Cell Network, CellCAN, the Canadian Pandemic Preparedness Hub, and the Canadian Biomanufacturing Cooperative.
More than that, we lead by example. We play a key role in the Canadian-Led Immunotherapies Collaborative, which developed the first made-in-Canada CAR-T cells. And Boreal is home to CanPRIME, the Canadian Partnership for Research in Immunotherapy Manufacturing Excellence, a partnership between The Ottawa Hospital, BioCanRx, and Mitacs, along with Algonquin College and the University of Ottawa, to train the next generation of biotech manufacturing professionals.
Wherever researchers and innovators are pursuing the next breakthroughs in viral vectors and cell therapies, we’ll be there—helping turn scientific promise into clinical progress.
An early-phase CDMO helps innovators transform promising scientific discoveries into therapies that are ready for clinical trials. At Boreal, that means helping researchers and biotech companies navigate the critical stages between proof of concept and clinical testing, including process development, analytical testing, GMP manufacturing, and supply of investigational products for early-stage clinical trials.
Early-phase CDMOs are focused on helping programs navigate the transition from preclinical development to clinical trials. They typically emphasize process development, flexibility, and regulatory readiness. At Boreal, we provide the scientific expertise and collaborative support needed when therapies are still taking shape. Late-phase CDMOs are generally optimized for large-scale manufacturing, commercial production, and supply chain management after a therapy has demonstrated clinical success.
Being embedded in a research hospital environment helps keep manufacturing decisions closely connected to the realities of clinical development. Through our connections to clinicians, researchers, and clinical trial expertise, Boreal operates within an ecosystem that understands the practical requirements of moving therapies into human studies. This can help identify potential challenges earlier and support more efficient planning as programs advance toward the clinic.
Technical expertise is essential, but it’s only part of the equation. Look for a partner with deep cell and gene therapy experience, strong GMP capabilities, proven quality systems, and the flexibility to adapt as your program evolves. Just as importantly, look for a team that sees itself as a partner on your journey, not simply a supplier. The most successful programs are often built on collaboration, shared problem-solving, and mutual commitment to clinical success.
Yes. While Boreal has significant expertise supporting oncology and rare disease programs, project opportunities are evaluated on a case-by-case basis. Organizations interested in exploring a potential collaboration are encouraged to contact the Boreal team to discuss their specific therapeutic area and development goals.
Boreal Biomanufacturing is based in Ottawa, Ontario, Canada.
A Canadian CDMO can offer the best of both worlds: access to world-class scientific expertise and a favourable cost environment for international organizations that can help make early-phase development resources go further without compromising quality or expertise. For Boreal clients, it also means working with a team that has spent two decades helping advanced therapies move toward the clinic.
Yes. Boreal is part of The Ottawa Hospital, one of Canada’s leading clinical research centres, with nearly 800 active clinical trials underway. We operate within an ecosystem that includes extensive clinical research expertise and experience. Through our network of researchers, clinicians, and collaborators, Boreal helps connect promising therapies to the resources required for successful clinical development.
Most CDMOs can manufacture products. Boreal was built to help innovators overcome the challenges that prevent promising therapies from reaching patients. We combine a mission-driven, non-profit model, connections that come from being embedded within a leading research hospital, and expertise gained through more than 20 years of advanced therapy development and manufacturing. Our approach emphasizes scientific collaboration and long-term partnership. Together, those qualities help our clients turn promising research into patient care.
Many large CDMOs are designed for scale. Boreal is designed for partnership. We work closely with innovators during the critical early phases of development, providing hands-on support, scientific engagement, and the flexibility needed to navigate complex and evolving programs. Our goal is to help clients overcome obstacles and advance promising therapies toward the clinic.
Many promising therapies stall not because the science is flawed, but because of challenges related to process development, manufacturing readiness, regulatory requirements, or access to specialized expertise. Boreal helps bridge the gap by offering established platform capabilities and manufacturing expertise, allowing innovators to build on proven approaches rather than developing everything from the ground up. This reduces risk and accelerates the transition from preclinical development to clinical trials.
Boreal specializes in cell and gene therapy manufacturing, with a focus on therapies for oncology and rare diseases. We have particular expertise in stem cell therapies, modified cell therapies (including CAR-T), oncolytic viruses, and viral vectors (including adenovirus, AAV, and LVV). Please see “CDMO Services” for more information.
At The Ottawa Hospital, research is integrated into patient care, enabling clinicians to offer innovative treatments and improve patients’ quality of life. Boreal contributes to this mission by transforming promising scientific discoveries into therapies that can be evaluated in clinical trials. By advancing innovations from the laboratory toward the clinic, we put the “Research Is Care” philosophy into practice.
The answer starts with our history. The Ottawa Hospital is one of Canada’s top centres for cancer research and is recognized as a global leader in the development of cancer biotherapeutics. Boreal was born from the need for specialized manufacturing to bring those cancer therapies into clinical testing. Today, many of the same advanced therapy platforms used in oncology are also being developed for rare diseases. As a result, Boreal has built deep expertise supporting both areas while remaining open to innovative programs across a range of therapeutic applications.
Advanced therapy development is rarely a straight line. Boreal was intentionally built to be flexible. Our team works closely with clients to respond to evolving data, changing priorities, and new opportunities. Rather than forcing programs to fit a rigid process, we focus on identifying the best path forward while maintaining quality and regulatory standards.
Boreal is part of The Ottawa Hospital, which is a member of the Ottawa Academic Health Network, a collaborative partnership that brings together the University of Ottawa, its affiliated hospitals, and research institutes. Boreal’s scientific advisors and many of its collaborators are scientists at the Ottawa Hospital Research Institute and professors at the University of Ottawa, and some hold clinical appointments at The Ottawa Hospital. These close connections help foster collaboration across research, education, clinical care, and biomanufacturing, supporting the development of innovative new therapies.
You’ve got a game-changing idea to treat cancer or rare disease. We’re ready to bring it to life. Let’s get started.
