PAT to the future: combining in silico tools and analytics for streamlining process development of aluminum-adjuvanted vaccines

Aluminum-based adjuvants are used in multiple commercial vaccines. However, optimization of drug product formulation and fill and finish processes still present challenges. Aluminum-containing vaccines are generally formulated in stirred tank reactors, as they have been proven to be the best vessel to ensure homogeneity of the product in the solid–liquid system, thus promoting adsorption during formulation phases and increasing the surface area of aluminum particles available for interaction with antigens. The stability of aluminum-containing vaccine suspensions is an important factor that affects several product quality attributes. In addition, antigen adsorption on the surface of aluminum particles may lead to a modification of their colloidal stability, which requires thorough investigation through diverse experiments and off-line analytics for a robust product design. Hence, analytical approaches and technologies that are able to properly characterize the behavior of aluminum-containing vaccine suspensions in stirred tank reactors may represent a game changer for vaccine process design and optimization.

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