탁월하게 강한 팀.
BioThera Solutions는 EV 생물학, 바이오제조, 임상 의학, 규제 업무, 사업 개발을 아우르는 교차 도메인 전문 지식으로 운영됩니다.
리더십
Frédéric St-Denis-Bissonnette
PhD — 설립자 & 최고경영자
프로필
세포외 소포(EV/엑소좀) 바이오제조에 깊은 전문 지식을 가진 PhD 훈련받은 과학자이자 연속 창업가. ISEV의 MISEV2023 지침 — 전 세계 EV 특성화의 현장 표준 — 에 명명된 기여자를 포함하여 최고 수준의 국제 저널에 다수의 동료 검토 제1저자 논문. 캐나다 및 글로벌 EV 커뮤니티에서 인정받는 리더이자 CanSEV 공동 창립자.
그는 ISEV MISEV2023 가이드라인의 명명된 기여자이자 캐나다 세포외 소포 학회(CanSEV)의 공동 창립자입니다. 연구실 밖에서는 과학, 커뮤니티, 상업 등 다양한 분야에 걸쳐 여러 벤처를 설립하고 이끌어 온 탁월한 실적을 보유하고 있습니다. BioThera는 그 모든 다양성이 하나로 수렴되는 곳입니다.
EV 커뮤니티 리더십
캐나다 전역의 선도적인 EV 연구자들과 함께 캐나다 세포외 소포 학회(CanSEV)를 공동 창립했습니다. 지속적인 이사회 멤버로 활동 — EV 연구, 임상 번역, 표준화 노력의 국가 조정을 주도합니다.
국제 세포외 소포 학회의 MISEV2023 지침 프로세스에 명명된 기여자 — 전 세계 EV 특성화, 제조, 데이터 보고의 현장 표준.
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.
분야를 형성하는 연구. 플랫폼을 정의하는 과학.
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.
중요한 이유:Establishes the knowledge and expertise behind BioThera's biomanufacturing approach. Demonstrates a GMP-compliant, serum-free hollow-fibre bioreactor workflow with extensive particle characterization — the foundation for a clinically relevant, fully scalable production system.
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.
중요한 이유:The field-defining global consensus standard for EV research (3,043+ citations). BioThera's CEO helped write the rulebook that governs acceptable EV characterization worldwide — we do not merely comply with MISEV2023, we helped establish it.
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.
중요한 이유:Validated potency assays are a regulatory requirement (Health Canada, FDA) for IND filing and clinical-grade lot release — directly addressing a key CMC gap and reducing regulatory risk.
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.
중요한 이유:Demonstrates how isolation method shapes EV surface composition and bioactive corona — directly informing BioThera's process design and batch-to-batch consistency standards.
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).
중요한 이유:Functional preclinical evidence that NK cell-derived EVs exert direct cytotoxic activity against both bulk triple-negative breast cancer cells and the cancer stem cell subpopulation associated with tumour recurrence — reinforcing the scientific case for BioThera's longer-term immuno-oncotherapeutic EV roadmap.
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).
중요한 이유:Published, reproducible step-by-step protocol for NK-EV manufacturing — confirms that the production process is documented, validated, 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.
중요한 이유:TEM imaging is a mandatory MISEV2023 characterization requirement. This uranium-free protocol addresses a key reproducibility gap and positions the founder at the frontier of EV characterization methodology.
DOI주요 인력
창립자를 보완하여, BioThera의 핵심 팀은 과학적 깊이, 재무 규율, 번역 전문 지식을 제공합니다.
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.
LinkedIn 프로필
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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