This is where your breakthroughs break through.

The cancer-fighting cell
and gene therapy CDMO

Bridge the Translational Gap →
Boreal cleanroom

The Ottawa Hospital’s Biotherapeutics Manufacturing Centre (BMC) — a not-for-profit, early-phase cell and gene therapy CDMO focused on turning promising advanced oncology and rare disease research into clinically proven therapies — is now Boreal Biomanufacturing.

A rich history of
manufacturing success.

Boreal is built on repeated success — on the production line, in patient rooms at The Ottawa Hospital, and out in the world.

This is where the hope that drives development of investigational products for cancer and rare disease is realized, through Phase I-III development and GMP-compliant production. It’s home to creative breakthroughs and disciplined manufacturing capabilities. And to a team of determined professionals working side-by-side with more than a thousand clinicians to give each patient something even better than hope: a tomorrow brighter than today.

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Pioneered the development of oncolytic virotherapy treatments

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Co-led development of the first made-in-Canada CAR-T therapy and public health infrastructure

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Fostered the development and successful launch of multiple advanced therapy start-ups

Boreal cleanroom manufacturing
Boreal researcher

Let’s work together
to make things better.

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.

Get Started

Phase I-III Contract Development
& Manufacturing Experts.

Go from the seed of an idea to a fully realized product.

Boreal brings together translational expertise and deep early-phase capabilities — as well as direct access to patients through a leading clinical centre conducting hundreds of active trials — to offer true bench-to-bedside capabilities, and streamline your efforts to turn research into care.

Our manual and automated solutions for personalized cancer therapies deliver the product modality that works best for your innovation. We specialize in the development of investigational products, whether your program requires a single dose or thousands.

  • Generation of material suitable for preclinical, toxicology studies and engineering batches
  • Analytical/microbiological method development
  • Upstream/downstream manufacturing process development
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  • Vectored products, autologous and allogenic cell products, and cell lines
  • Master cell and virus banks
  • GMP-compliant Production for Investigational Products
  • In accordance with Health Canada GUI-0001 & GUI-0119 and U.S. Food and Drug Administration 21CFR210 and 21CFR211
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  • Testing of incoming raw materials for production
  • Sampling and testing of GMP environmental and personnel monitoring
  • GMP-compliant, product analytical testing
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  • Clinical Trial Application (CTA) preparation and lifecycle management
  • Chemistry, Manufacturing and Controls (CMC) documentation
  • Health Canada strategy and communication
  • Pre- and post-submission support
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Boreal by the numbers

Work with people who’ve put in the work.

19Years of manufacturing experience
300+Clinical batches produced
15+Phase I-III clinical trials supported

The Boreal Difference.

The early-phase CDMO for oncology and rare disease.

As unique as a fingerprint.

Every project — just like every cancer, and every patient — is unique. Our processes evolve to ensure we give our clients’ therapies every chance to succeed. The focus is always on results, and relentlessly working our way toward the best, most efficient way to achieve them.

As interconnected as
the boreal forest.

You get the benefit of our deep roots: almost 20 years of insight, experience, and institutional knowledge. So you can count on getting expert guidance, making the right connections, and giving your advanced therapy the greatest chance to grow and thrive.

As dynamic as a
living promise.

We take the trust you put in us seriously. At every step, we evaluate, strategize, and enhance — establishing the conditions for success, supporting the transition from preclinical development to first-in-human studies, and helping programs progress through rigorous clinical development.

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Oncology and rare disease viral vector and cell therapy experts.

Implausible missions welcome.

Our clients think big, no matter what size organization they come from. They’re tackling some of the most complex challenges in medicine, and they need a partner with the expertise to help turn ambitious ideas into clinical-stage therapies.

Sound like you?

You’ll find a proven, fully engaged ally in Boreal.

We can help you advance complex therapies swiftly and strategically. We can take your inspired ideas and transform them into real-world breakthroughs. And we can do the most important thing of all: streamline the path from bench to bedside and speed the delivery of viable, clinically tested treatments.

Start Here →
Boreal technician

GMP Facilities for viral
vector and cell and gene
therapy manufacturing.

Boreal already offers advanced therapy development, production, and quality control capabilities here in our Canadian facilities, including six CL2 GMP suites across multiple grades.

And they’re about to get even better. In 2029, we’ll double our current capacity with the opening of our new facility inside the University of Ottawa’s Advanced Medical Research Centre, bringing Boreal together with researchers, innovators, and biotechnology companies in a collaborative environment designed to accelerate therapeutic development.

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Boreal facility

Frequently Asked Questions

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.

Picking the right CDMO

Your first early-phase win?
Picking the right CDMO.

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.