A sample is loaded into a centrifuge capable of generating very high gravitational force and spun in sequential steps to separate particles by size and density, with the vesicle fraction pelleted and resuspended. Request the product-specific preparation and analytical documentation rather than relying on a general description of the method.
Spin time, rotor type and sample viscosity can affect the yield and purity of the recovered fraction, which is one reason two labs processing similar starting material can report different particle counts or marker profiles. Ask which parameters a supplier used and request the supporting documentation for a specific lot.
For a buyer, the isolation method used is part of the characterization record, not a detail to skip past. It affects what a nanoparticle tracking analysis or marker panel on a certificate of analysis actually represents. MISEV2023 recommends that extracellular vesicle preparations disclose the isolation method alongside particle characterization data, which gives clinics a basis for the documentation to request from a supplier before evaluating a lot.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice. Exosome and extracellular vesicle products are not FDA approved. They are generally regulated as biologic drugs under section 351, and purchase and clinical-use decisions rest with the physician and their own regulatory counsel.
The isolation method shapes what population of particles a supplier's characterization data actually describes, which matters when a clinic is comparing documentation across lots or suppliers.