Table 2 Differences in CMC considerations for EVs vs. LNPs as vaccine vehicles
From: Engineered EVs with pathogen proteins: promising vaccine alternatives to LNP-mRNA vaccines
Aspect | EV-based vaccines | LNP-based vaccines |
|---|---|---|
Product Characteristics | Complex Characteristics requiring multiple assays e.g., NTA, TEM, mass spectrometry, ELISA, flow cytometry | Precise lipid composition: standardized lipid, size, and charge characterization |
Manufacturing Process | A biological process using eukaryotic cells | A chemical process where the RNA is synthesized by enzymatic reaction or by microbials |
Product testing | Cell debris, protein aggregates purity | Lipid and chemical/biological reactants; Elimination of contaminants through purification steps; Meticulous control of lipid purity and reactants |