Systematic Development and Validation of a Bradford-Based Protein Quantification Method for Novel Multi-Dose R21 Malaria Vaccine Formulated with 2-Phenoxy Ethanol (2-PE).

ABSTRACT: Background: The R21 malaria vaccine is a next-generation, WHO-prequalified vaccine that was introduced to reduce the burden of clinical malaria. In alignment with WHO recommendations, multi-dose vaccine presentations are preferred for large-scale immunization and inclusion in the Expanded Programme on Immunization (EPI). Accurate protein quantification is a critical quality control parameter for lot release, but it remains challenging when the antigen is present at low protein concentrations or formulated with complex matrices, including adjuvants, stabilizers, and preservatives. Methods: In this study, multiple protein estimation methods including Micro-BCA, BCA, and Bradford assays were evaluated to determine their suitability for quantifying the R21 antigen formulated with

SUBMITTER: Jena R 

PROVIDER: S-EPMC12846647 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature