Methods for Assessment of OMV/GMMA Quality and Stability.

Outer membrane vesicles (OMV) represent a promising platform for the development of vaccines against bacterial pathogens. More recently, bacteria have been genetically modified to increase OMV yield and modulate the design of resulting particles, also named generalized modules for membrane antigens (GMMA). OMV/GMMA resemble the bacterial surface of the pathogen, where key antigens to elicit a protective immune response are and contain pathogen-associated molecular patterns (e.g., lipopolysaccharides, lipoproteins) conferring self-adjuvanticity. On the other hand, OMV/GMMA are quite complex molecules and a comprehensive panel of analytical methods is needed to ensure quality, consistency of manufacture and to follow their stability over time. Here, we describe several procedures that can be used for OMV/GMMA characterization as particles and for analysis of key antigens displayed on their surface.