Aluminum Phosphate Vaccine Adjuvant: Analysis of Composition and Size Using Off-Line and In-Line Tools

Structure and compositional analysis of aluminum oxyhydroxide adsorbed pertussis vaccine

“…4 ) contain rich information that can be used for in-process testing to verify vaccine bulk drug product identity prior to filling. These observations were similar to those observed for AlPO 4 adsorbed vaccines reported previously [21] , [26] , [29] .…”

“…Process analytical technology (PAT) can be used for inline monitoring of material attributes, critical quality attributes, to enable real time characterization of vaccine formulations. It has been previously demonstrated that in-line PAT can be used to monitor particle size and chemical composition for the various stages of adjuvant manufacturing from raw materials through intermediate to final adjuvant product stage [26] . In this study, a feasibility of two in-line methods was assessed for their potential use in multivalent vaccine formulation.…”

Immunodominance of Epitopes and Protective Efficacy of HI Antigen Are Differentially Altered Using Different Adjuvants in a Mouse Model of Staphylococcus aureus Bacteremia

“…AlPO 4 is a classic adjuvant that is used in most approved vaccines. It enhances the immune response by facilitating phagocytosis and slowing the diffusion of antigens from the site of injection, and it efficiently induces a Th2 immune response (30). AddaVax is a squalene-based oil-in-water nanoemulsion that efficiently elicits both cellular and humoral immune responses (31).…”

Aggregation and Size Attributes Analysis of Unadsorbed and Adjuvant-adsorbed Antigens using a Multispectral Imaging Flow Cytometer Platform

“…Particle size is often measured by laser diffraction (LD) or dynamic light scattering (DLS) depending on the size range and sample composition. 23,24 Specifically, LD may be suitable for both aluminum salt adjuvant-based samples and unadsorbed antigens in the micrometer range, whereas DLS is suitable for assessing the oligomeric state of proteins in the nanometer size range but does not accurately measure size of complex size distributions which may occur upon aggregation. While these techniques can detect changes in size, visualization of the particles is often dependent on microscopy.…”