Extracellular vesicles (EV) are submicron membrane vesicles released by most cells with a fundamental role in cell-to-cell communication. Much interest is flourishing towards their exploitation in therapy and diagnostics. However, the fulfilment of the EV promise is hampered by severe limitations in their isolation, characterization and manufacturing. A particularly arduous task is to move the isolation of specific EV subpopulations beyond the analytical scale and towards scalable processes. MARVEL targets a paradigm shift from antibodies to peptides as an alternative class of affinity ligands for EV capturing by introducing membrane-sensing peptides (MSP) as novel ligands for the capturing of small EV, unbiased by differential surface protein expression. MARVEL mission is to combine and implement reversible isolation and MSP technologies, towards the first and best performing ever affinity-based technology for scalable small EV (<200nm) isolation. The modularity in scaling-up of the novel protocols and kits has been demonstrated on medium/large sample volumes in relevant environments for therapeutic and diagnostics use of EVs and specifically: 1) In the lab-scale manufacturing of EVs as a medicinal product for cardiac repair; 2) In urine-based liquid biopsy for bladder cancer prognosis; 3) in a blood-based workflow for cardiac risk assessment.
MARVEL demonstrated (TRL 6):
• The peptide-based workflow is highly effective in isolating and enriching EVs from conditioned medium, urine, plasma and serum with minimal carry over of contaminants
• Peptide conjugated beads enable the release of structurally intact EVs with no decrease in efficacy.
• The peptide-based workflow can be directly applied using various analytic platforms
A business plan based on multiplatform integration of MSP (Ingredient Model) has been developed opening entrepreneurial perspectives