Carlo Giannelli, Francesca Necchi, Elena Palmieri, Davide Oldrini, Beatrice Ricchetti, Maria M Papathanasiou, Zoltan Kis, Cleo Kontoravdi, Cristiana Campa, Francesca Micoli
In recent years, Generalized Modules for Membrane Antigens (GMMA) have received increased attention as an innovative vaccine platform against bacterial pathogens, particularly attractive for low- and middle-income countries because of manufacturing simplicity. The assessment of critical quality attributes (CQAs), product-process interactions, identification of appropriate in process analytical methods, and process modeling is part of a robust quality by design (QbD) framework to support further development and control of manufacturing processes...
March 8, 2024: AAPS Journal