Our opportunity, our challenge
"Exosome therapy is in its infancy, and the industry must address safety, efficacy, and regulatory issues to realize the potential of promising exosome-based therapies."
Wang et al., Clinical and Translational Science (2024)
Where Rapid Innovation Meets Rigorous Oversight
EXACT™ OVERSIGHT BUREAU is an Independent Association dedicated to establishing comprehensive oversight and quality assurance standards for the rapidly evolving exosome industry. As the definitive global authority for exosome auditing, compliance, and testing, we serve as the critical bridge between innovation and safety in regenerative medicine and aesthetics.
Our Mission
To establish comprehensive oversight and quality assurance standards for the exosome industry through rigorous auditing, compliance testing, and validation protocols. We develop foundational frameworks that ensure the highest quality bioactive products while empowering physicians and patients with complete transparency regarding product composition, cargo, and signaling pathways.
Our Vision
To be the globally recognized authority for exosome quality assurance and regulatory compliance, setting the gold standard for manufacturing, characterization, and validation that transforms the exosome industry into a trusted, transparent, and scientifically rigorous field of regenerative medicine.
Why EXACT™ Matters
The exosome industry stands at a critical juncture where rapid growth has outpaced standardized oversight. Recent research confirms that exosome therapy is in its infancy and the industry must address safety, efficacy, and regulatory issues to realize therapeutic potential. Current global regulatory approaches vary dramatically, creating fragmentation that complicates both compliance and enforcement.
Critical challenges we address:
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Product heterogeneity and batch-to-batch variability
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Lack of standardized testing methodologies
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Quality control gaps in current manufacturing processes
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Regulatory fragmentation across global markets
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Consumer protection in an unregulated landscape
Our Core Pillars
EXACT™ is built on six foundational pillars that define our comprehensive approach to exosome industry oversight:
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Testing. Independent lab analysis of exosome products with detailed quality reports and MISEV compliance verification.
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Education. Evidence-based resources, webinars, and training on exosome best practices and regulatory compliance.
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Auditing. Facility and process audits to verify and certify compliance with EXACT manufacturing standards.
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Standards. Developing manufacturing and validation requirements aligned with FDA, ISO, and ISEV frameworks.
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Community. Connecting stakeholders through networks and forums to advance exosome quality standards.
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Compliance. Expert guidance on regulatory requirements, quality systems, and global standards alignment.
EXACT™ Oversight Bureau Standards Framework
Setting the Global Benchmark for True Exosome Authenticity and Patient Safety
Core Scientific Principle
Exosomes are the only extracellular vesicles formed through the endosomal pathway — the origin that gives them their unique ability for targeted cell-to-cell communication and regenerative function.
EXACT™ certifies only biologically authentic, functionally active exosomes — never unverified particles or unpurified media.
1. Biological Source & Production Integrity
Origin matters. Only vesicles produced in metabolically active cells through the endosomal (multivesicular body) pathway qualify as true exosomes.
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Single, well-characterized cell type — no mixed sources
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Full donor screening and safety evaluation
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Healthy, age-appropriate tissues only
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Complete traceability from source to product
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Regular Bureau audits ensure compliance
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Endosomal origin • Patient safety • Traceability
2. Size Verification — “Size Alone Is Not Quality”
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True exosomes range between 50–150 nm.
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Nanoparticle Tracking Analysis (NTA) confirms particle size but does not define authenticity.
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NTA confirmation • Structural verification • Functional validation
3. Bilipid Layer Integrity
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Structure defines function.
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Authentic exosomes form through endosomal budding, creating intact double-lipid vesicles verified by Transmission Electron Microscopy (TEM).
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Vesicles without intact membranes are non-functional and non-certifiable.
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TEM verification • Intact membrane • Functional vesicles
4. Biogenesis Marker Verification
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Proof of endosomal origin.
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Certified exosomes must express key markers: CD9, CD63, CD81, TSG101, ALIX, SYN - verified by immunoblot or flow cytometry.
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Endosomal markers • Authentic biogenesis • Verified function
5. Continuous Oversight & Certification
EXACT™ oversees all production stages - from cell culture to storage.
Only products meeting all standards receive the EXACT™ Certification Seal.
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Verified endosomal origin
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Intact bilipid membrane
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Authentic biogenesis markers
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Full traceability
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Patient/client safety
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Full lifecycle control • Ongoing audits • Global certification
The EXACT™ Certification Seal
The ultimate mark of trust, authenticity, and verified science in exosome therapeutics.
Products carrying this seal are:
Biologically authentic • Functionally active • Scientifically verified • Safe for patients and clients
“Size defines a particle. Biology defines an exosome.”
- EXACT™ Oversight Bureau
The EXACT™️ Core Team
Dr. Carla Mazzeo, PhD
Director, Exosome Science, Research & Education
Dr. Mazzeo is a leading exosome expert with 20+ years in extracellular vesicles research. Her doctoral work focused on exosome biogenesis, exploring their potential as drug delivery vehicles and diagnostic/therapeutic agents. She completed post-graduate studies at MIT in Drug and Medical Device Development and directs Boston University's Extracellular Vesicles Studies Core. Her research spans cancer (melanoma, breast), gastroenterology (IBD), asthma, immunology, diabetes, and cardiovascular conditions. A highly accomplished scientist, she's published in top journals and co-authored the latest MISEV guidelines. As Director, she ensures rigor and standardization across the EXACT Oversight Bureau's pillars: Education, Auditing, Compliance, and Testing.
Dr. Ortega is an accomplished physician-researcher specializing in regenerative medicine, with expertise in stem cells, exosomes/extracellular vesicles, and medical 3D printing. Medical licensed in Mexico and Spain, with extensive experience in clinical research, healthcare management, and biotechnology innovation. Proven track record of leading research initiatives and implementing advanced medical technologies, while building strong healthcare community partnerships. Core strengths include clinical research methodology, regenerative medicine applications, and healthcare technology integration. Dedicated to advancing medical science through practical patient care solutions and professional collaboration.
Nancy Preston
Head of Business Development and Membership Services
Nancy brings over 25 years of marketing and business development expertise to EXACT, with specialization in advanced skincare technologies and regenerative aesthetics. As Director of Marketing at Penn Smith Skincare since 2020, she has focused on translating complex scientific innovations into accessible, evidence-based content for the consumer market. Her extensive consultancy experience spans nearly two decades, working with leading brands in skincare and regenerative therapeutics. At EXACT, she oversees membership services, strategic partnerships, and industry outreach initiatives, ensuring the organization's standards reflect both scientific rigor and practical market needs.