Where oncology and rare disease innovations start with confidence
Boreal Biomanufacturing serves its biotech and academic partners through a full suite of proven manufacturing capabilities, from process development to fill-finish, all done according to good manufacturing practice (GMP) standards.
At Boreal, our PAD services provide critical early insights into product quality, manufacturability, and scalability—helping you optimize your process and streamline later stages of development.
Boreal specializes in the development and GMP-compliant production of Phase I–III investigational products. Whether you’re developing a viral vector, cell therapy, or another advanced therapeutic, we work alongside you to design the manufacturing approach best suited to your program—even when that requires a novel manufacturing strategy.
Our team established foundational science in oncolytic viruses and co-led the manufacture of Canada’s first home-grown CAR-T therapy. That pioneering experience enables us to support some of the most innovative programs in advanced therapeutics today.
Let’s talk about how we can advance your advanced therapy together, from promise to patient.
Get StartedQuality is built into every stage of our process. Our dedicated quality control (QC) and quality assurance (QA) team at Boreal provide the analytical expertise and robust quality systems needed to support clinical manufacturing and release of your investigational product.
Regulatory support at Boreal is tailored to meet the unique needs of each program, enabling clients to leverage our expertise where it provides the greatest value.
At the strategic level, our team can assess how manufacturing process decisions may influence regulatory requirements, submission strategies, and development timelines. At the operational level, we provide regulatory support throughout the product lifecycle, including the preparation of regulatory submissions and responses to Chemistry, Manufacturing, and Controls (CMC) information requests. Our collaborative approach helps clients navigate complex regulatory requirements while supporting efficient and compliant product development.
Put simply, we know what to expect: We know the timelines, the meetings required with regulatory authorities, which expertise will be called on at each point in the process, and how to facilitate open lines of communication.
Our PAD services provide critical early insights into product quality, manufacturability, and scalability. We offer upstream and downstream process development using a DoE approach, analytical and microbiological method development, engineering batch manufacturing, and seamless technology transfer to GMP readiness.
Boreal manufactures viral vectors (including oncolytic viruses, vaccines, virus-like particles, exosomes, and gene therapy viruses across AAV, LVV, and other platforms), autologous and allogenic cell therapies (including CAR-T and TILs), and cell lines. We also produce master cell and virus banks.
Yes. Our regulatory team provides Chemistry, Manufacturing, and Controls (CMC) documentation as part of our comprehensive regulatory services, supporting Clinical Trial Application (CTA) preparation and lifecycle management.
Yes. Boreal produces GMP-compliant master cell and virus banks as part of our manufacturing services for investigational products.
Yes. Our facilities support GMP-compliant production of both drug substance and drug product, including manual aseptic fill-finish of 2R vials up to 500 units.
Yes. Our regulatory team provides full-spectrum support — from CTA preparation and lifecycle management to CMC documentation, Health Canada strategy, and pre- and post-submission support. We know what to expect at each stage and can help you navigate regulatory requirements efficiently.
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.
