Un equipo excepcionalmente sólido.
BioThera Solutions opera con experiencia multidisciplinar que abarca biología de EV, biofabricación, medicina clínica, asuntos regulatorios y desarrollo comercial.
Liderazgo
Frédéric St-Denis-Bissonnette
PhD — Fundador y Director Ejecutivo
Perfil
Científico con doctorado y emprendedor en serie con profunda experiencia en biofabricación de vesículas extracelulares (EV/exosomas). Múltiples publicaciones revisadas por pares como primer autor en revistas internacionales de primer nivel, incluyendo contribuyente nombrado en las directrices MISEV2023 de ISEV.
Es contribuyente nombrado en las directrices ISEV MISEV2023 y cofundador de la Sociedad Canadiense de Vesículas Extracelulares (CanSEV). Fuera del laboratorio, tiene una trayectoria comprobada en la creación — habiendo fundado y liderado múltiples iniciativas en contextos científicos, comunitarios y comerciales. BioThera es donde converge esa amplitud.
Liderazgo en la comunidad EV
Cofundó la Sociedad Canadiense de Vesículas Extracelulares (CanSEV) junto a investigadores líderes en EV de todo Canadá. Sirve como miembro permanente del consejo — impulsando la coordinación nacional de la investigación en EV.
Contribuyente nombrado al proceso de directrices MISEV2023 de la Sociedad Internacional de Vesículas Extracelulares — el estándar de oro del campo para la caracterización, fabricación y reporte de datos sobre EV en todo el mundo.
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. It is now crossing borders, powered by a Fulbright Canada Entrepreneurship Award and hosted at MIT.
“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.
Investigación que da forma al campo. Ciencia que define la plataforma.
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.
Por qué importa: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.
Por qué importa: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.
Por qué importa: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.
Por qué importa: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.
Por qué importa: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).
Por qué importa: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 plant-derived EV skincare 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).
Por qué importa: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.
Por qué importa: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.
DOIPersonal clave
Complementando al fundador, el equipo principal de BioThera aporta profundidad científica, disciplina financiera y experiencia traslacional.
Karan MedirattaPhD Candidate
Chief Scientific Officer
Doctoral-level scientist specializing in extracellular vesicle (EV/exosome) biology. Brings deep experimental expertise to BioThera's scientific strategy, characterization protocols, and platform development. Leads R&D execution, manufacturing validation, and product optimization across BioThera's EV biomanufacturing pipeline.
Perfil de LinkedIn
Michael KingCPA
Financial Controller
Experienced financial professional with a track record across early-stage life sciences and biotech ventures in the Ottawa ecosystem. Ensures BioThera's financial operations, reporting, and compliance infrastructure are built to scale.
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