What we offer
Initially, the EXACT™️ team will focus on providing access to our testing services. EXACT's testing protocols establish standardized methods for verifying exosomes quality, integrity, and biological source. Developed by Dr. Carla Mazzeo in collaboration with leading research institutions at Harvard Medical School and Boston University, our comprehensive characterization includes transmission electron microscopy (TEM) for membrane integrity, cargo analysis for functional miRNA/mRNA content, and verification of human tissue origin—the critical factors that determine whether exosomes can effectively communicate with human cells.
As we build our comprehensive oversight framework, testing and certification form the foundation of EXACT's current operations. Additional services including educational programs, regulatory guidance, and the establishment of industry standards are actively under development and will launch in the coming eighteen to twenty four months. We'll be providing regular updates on these initiatives via our monthly newsletters, so do subscribe if you'd like to keep informed. And, of course, organizations interested in shaping these emerging programs are encouraged to contact us.
For testing protocol information, sample submission requirements, or certification criteria, please contact our scientific team directly via the Contact Form below
Testing
Independent laboratory analysis to characterize and evaluate existing exosome products and source, providing detailed reports on quality, composition, and adherence to MISEV/international standards.
Education
Advancing industry knowledge through evidence-based blogs, expert webinars, and educational resources that promote best practices in exosome characterization, quality assurance, and regulatory compliance.
Auditing
Independent facility and process audits to verify compliance and grant certification, confirming that manufacturing systems, protocols, and quality controls meet EXACT standards for approved operations.
Developing comprehensive manufacturing, characterization, and validation requirements through collaborative expert consensus, aligning with FDA, ISO, ISEV, and international regulatory frameworks.
Standards
Connecting industry stakeholders, researchers, and healthcare providers through collaborative networks, working groups, and forums for sharing knowledge and advancing exosome quality.
Community
Providing expert guidance on meeting regulatory requirements and implementing quality systems ensuring product safety, proper documentation, and alignment with evolving global standards.