ArticleVaccines2025
New High-Throughput Method for Aluminum Content Determination in Vaccine Formulations.
Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Aluminum adjuvant promotes liver inflammation and fibrosis in mice: A novel approach to establish a liver fibrosis animal model.Liver research (Beijing, China) · 2025Article
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Authors and funding
13 authors.
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Abstract
objectiveThis manuscript describes an innovative, non-destructive, high-throughput method for the quantification of aluminum hydroxide in aluminum-adjuvanted vaccines, eliminating the need of reagents and providing real-time results. The method is based on a spectrophotometric principle, and several model proteins were studied and tested with the aim to simulate the behavior of aluminum-adjuvanted antigens.
methodsAs a proof of concept, the MenB vaccine was used, and the titration of aluminum hydroxide (AH) with ethylenediaminetetraacetic acid (EDTA) was used as an orthogonal reference, as it is one of the current release methods for the content determination of aluminum-hydroxide-adjuvanted vaccine drug products (DPs). The factors influencing the spectrophotometric analysis, such as different plate 96/well containers, variation in the sedimentation of the suspension due to component addition errors during formulation, and batch-to-batch variation were studied to assess the method's robustness. Five concentration levels (ranging from 2.0 to 4.0 mg/mL AH) with two different batches of aluminum hydroxide were each measured with independent preparations performed by three different operators, for a total of four sessions/operator and 20 formulations/session. An in-depth statistical study was carried out with generated data to assess the precision (in terms of intermediate precision and repeatability), accuracy, linearity, and specificity of the method.
resultsThe novel spectrophotometric method and the official release one (potentiometric) yielded comparable results, demonstrating the potential of this new method as a release test for AH-adjuvanted products. A simple calibration curve enabled the measurement of samples in a 96-well plate in just a few minutes.
conclusionsWe developed a novel method for Aluminum concentration determination in Aluminum-containing pharmaceutical products, like alum-adjuvanted vaccines. This method is fast, completely automatable, and as precise and accurate as already-in-place release methods.
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