实力卓越的团队。
BioThera Solutions凭借横跨EV生物学、生物制造、临床医学、监管事务和业务开发的跨领域专业知识运营。
领导层
Frédéric St-Denis-Bissonnette
PhD：创始人兼首席执行官
简介
拥有深厚细胞外囊泡（EV/外泌体）生物制造专业知识的博士训练科学家兼连续创业者。在顶级国际期刊上发表了多篇同行评审第一作者论文，包括被命名为ISEV MISEV2023指南，全球EV表征领域标准，的贡献者。加拿大及全球EV社区公认的领袖，CanSEV联合创始人。
他是ISEV MISEV2023指南的具名贡献者，也是加拿大细胞外囊泡学会（CanSEV）的联合创始人。在实验室之外，他拥有丰富的创业经历，曾在科学、社区和商业等多个领域创立并主导多项事业。BioThera正是这一切交汇之处。
EV社区领导力
Co-founded the Canadian Society for Extracellular Vesicles (CanSEV) alongside leading EV researchers across Canada. Serves as an ongoing board member, driving national coordination of EV research, clinical translation, and standardization efforts.
Named contributor to the International Society for Extracellular Vesicles' MISEV2023 guidelines process, the field's consensus standard for EV characterization and data reporting worldwide.
From a uOttawa Side-Project to MIT & Fulbright
BioThera Solutions was born from a conviction formed during doctoral research at the University of Ottawa: that the EV field needed a dedicated vehicle to accelerate its path to commercial reality. Powered by a Fulbright Canada Entrepreneurship Award hosted at MIT, it is now establishing manufacturing capacity in Ottawa first, with the goal of scaling across North America.
“Too many anti-aging products make claims science cannot support. We are building the science that changes that. Extracellular vesicles are not just another ingredient. They are a fundamental biological communication system the body already uses, and one of the most compelling platforms science has uncovered for extending human healthspan. The goal was never simply to live longer. Medicine 3.0 asks a harder question: how do we add healthy, functional years, not just years? How do we delay the onset of the chronic diseases that quietly erode quality of life decades before they kill? That is the question BioThera is built around.”
Doctoral research at the University of Ottawa and Health Canada's Centre for Oncology, Radiopharmaceuticals and Research, supervised by Drs. Jessie R. Lavoie and Lisheng Wang. The focus: developing clinically relevant, scalable biomanufacturing workflows for EV-based cancer biotherapeutics, specifically natural killer cell-derived EVs for cancer immunotherapy. What began as rigorous academic science became the technical foundation of BioThera Solutions.
That conviction took its first commercial form through the uOttawa eHub Startup Garage: first the RevUp Circuit bootcamp, then the Exploration Circuit for tailored, one-on-one venture development. The mentorship provided through both programs was instrumental in shaping BioThera into a commercially grounded venture. BioThera took first place at the annual Rally Day pitch competition, marking the transition from research concept to investable company. Lab2Market, a national STEM commercialization program, further deepened go-to-market strategy and regulatory positioning through an equally exceptional mentorship experience. Along the way, BioThera joined forces with Momentum A.I.R., an innovation hub bridging academia and industry to de-risk and validate STEM ventures for investment readiness.
Selected as a 2025–2026 Fulbright Canada Short-Term Entrepreneurship Award recipient, a binational distinction recognizing outstanding innovators who demonstrate both exceptional scientific promise and the entrepreneurial vision to bring their work to market. Hosted at MIT in April 2026, the residency focuses on advancing BioThera's North American commercialization pathway: regulatory positioning, manufacturing scale-up strategy, and U.S. market entry.
Fulbright Canada is a binational, treaty-based organization supported by Global Affairs Canada and the United States Department of State, identifying outstanding innovators across both countries for residential academic and entrepreneurial exchange.
With the commercialization pathway mapped, BioThera is establishing its extracellular vesicle manufacturing capacity in Ottawa first, building a national foundation in Canada before expanding. The goal: scaling operations across North America, carrying the same MISEV2023-characterized, batch-documented standard into every new market.
What Research Underpins BioThera's EV Platform?
Note: Not all of the following publications are directly related to BioThera's current technology. Many originate from doctoral research in cancer immunotherapy and NK cell-derived EVs. The scientific methods, manufacturing rigor, and characterization expertise developed across these studies directly inform BioThera's approach, even where the biological context differs.
F. St-Denis-Bissonnette et al. A clinically relevant large-scale biomanufacturing workflow to produce natural killer cells and natural killer cell-derived extracellular vesicles for cancer immunotherapy. Journal of Extracellular Vesicles.
重要原因：We built this because EV (EVs/exosomes) therapeutics cannot reach the clinic without a production method that is both scalable and clinical-grade. We learned that a GMP-compliant, serum-free hollow-fibre bioreactor workflow can generate natural killer cells and their EVs at clinically relevant scale with full particle characterization. For BioThera, this scalable, standards-first manufacturing and characterization blueprint is the direct foundation for how we produce and verify our plant-derived EVs today.
DOIWelsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, St-Denis-Bissonnette F, et al.; Théry C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. Journal of Extracellular Vesicles.
重要原因：We took part because the EV (EVs/exosomes) field lacked a unified standard, which made results hard to compare and products hard to trust. The outcome was a global ISEV consensus defining the minimum characterization, reporting, and quality controls required to credibly call a preparation an EV product (3,043+ citations). For BioThera, the CEO being a named co-author means we do not merely comply with MISEV2023, we helped write the rulebook every credible EV product is now measured against.
DOIF. St-Denis-Bissonnette et al. Natural killer cell-derived extracellular vesicles reprogram cellular human immunity to enhance tumor cytotoxicity. Molecular Therapy Oncology.
重要原因：We ran this to test whether extracellular vesicles (EVs/exosomes) can actively reprogram recipient cells rather than act as passive cargo carriers. We learned that they can: natural killer cell EVs reprogrammed human immune cells toward enhanced tumor cytotoxicity. For BioThera, this confirms the biological premise behind our platform, that well-characterized EVs are functional messengers capable of instructing cell behaviour, and reflects the EV engineering and characterization rigor the founder brings to our plant-derived EV work.
DOIF. St-Denis-Bissonnette et al. Evaluation of resazurin phenoxazine dye as a highly sensitive cell viability potency assay for natural killer cell-derived extracellular vesicle-based cancer biotherapeutics. Journal of Extracellular Biology.
重要原因：We developed this because clinical-grade EV (EVs/exosomes) products need validated potency assays for lot release and regulatory filings (Health Canada, FDA), and that was an open methods gap. We learned that a resazurin phenoxazine dye works as a highly sensitive cell-viability potency assay for natural killer cell EV biotherapeutics. For BioThera, the same assay-development discipline underpins our batch-release testing and characterization standards, directly lowering regulatory risk as the platform scales.
DOIF. St-Denis-Bissonnette et al. Ultracentrifugation and Ultrafiltration Differentially Alter the Composition and Functionality of the Biomolecular Corona of Extracellular Vesicles. Journal of Extracellular Biology.
重要原因：We investigated this because how you isolate EVs (EVs/exosomes) may quietly change their surface and function, yet that effect was poorly characterized. We learned that ultracentrifugation and ultrafiltration differentially alter the composition and functionality of the EV biomolecular corona. For BioThera, this directly informs our process design and batch-to-batch consistency standards, since the isolation method we choose shapes the bioactive surface of the final product.
DOIM. Kirkby, F. St-Denis-Bissonnette et al. Natural Killer Cell-Derived Extracellular Vesicles Exhibit Cytotoxicity Against Bulk Tumor Cells and Cancer Stem Cells in Triple-Negative Breast Cancer. Nanomaterials (MDPI).
重要原因：We asked whether natural killer cell EVs (EVs/exosomes) could act not only against bulk tumor cells but also the treatment-resistant cancer stem cells that drive relapse. We learned that in triple-negative breast cancer models they showed cytotoxicity against both populations. For BioThera, the depth of functional EV characterization developed here reflects the analytical rigor and scalable EV biomanufacturing know-how that underpins our EV biomanufacturing platform today.
DOIF. St-Denis-Bissonnette et al. Scalable Biomanufacturing Workflow to Produce and Isolate Natural Killer Cell-derived Extracellular Vesicle-based Cancer Biotherapeutics. Journal of Visualized Experiments (JoVE).
重要原因：We published this because a manufacturing process is only valuable to partners if it is documented reproducibly enough to transfer. The result is a peer-reviewed, step-by-step protocol to produce and isolate natural killer cell EV (EVs/exosomes) biotherapeutics. For BioThera, it confirms that our underlying production know-how is fully documented, reproducible, and ready for tech transfer and partnership.
DOIF. St-Denis-Bissonnette et al. An Optimized Positive Staining Protocol for Clear Visualization of Extracellular Vesicles by TEM Using Uranyless and Lead Citrate. Langmuir.
重要原因：We optimized this because TEM imaging is a mandatory MISEV2023 characterization step, yet the standard uranium-based stains are hazardous and inconsistently reproducible. We learned that a uranium-free positive-staining protocol (Uranyless with lead citrate) gives clear visualization of extracellular vesicles (EVs/exosomes) by TEM. For BioThera, it closes a reproducibility and safety gap in a required characterization method and keeps our characterization toolkit at the methodological frontier.
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