ArticleVaccines2026
Formulation Development of a Multivalent Bioconjugate ExPEC Vaccine Candidate: Linking Early Design to Late-Stage Stability and Manufacturability.
Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
backgroundExPEC9V was a 9-valent vaccine candidate intended for the prevention of invasive extraintestinal pathogenic
methodsSelected formulation development studies of the ExPEC multivalent vaccine candidate are summarized, spanning formulation screening, confirmation, and design of experiments (DoE)-based robustness, stability and compatibility studies. A formulation initially developed for an early low-valency vaccine candidate was subsequently tested and confirmed for candidates with additional serotypes incorporated based on antigen heterogeneity evidence. Contact materials employed included primary packaging-polycarbonate (PC) and polyethylene terephthalate glycol (PETG) bottles, borosilicate glass vials, stoppers, and prefilled syringes; vessel types-bags and stainless steel vessels used in drug substance (DS) and drug product (DP) manufacturing; and varying concentrations of tungsten and hydrogen peroxide. An evolving analytical panel was applied to assess attributes such as purity, protein concentration and degree of O-acetylation.
resultsA phosphate-based formulation containing sorbitol, methionine, and polysorbate 80 showed superior stability in screening and was confirmed as fit for purpose across increasing vaccine valency. The ExPEC 9V drug product displayed remarkable thermal and formulation robustness, long-term (3 years) stability at 2-8 °C in glass vials and prefilled syringes, and compatibility with assessed primary containers and manufacturing materials. DoE-based robustness studies defined acceptable excipient and pH ranges, supporting a wide formulation design space.
conclusionsThe development trajectory of the ExPEC9V vaccine candidate demonstrates that early prioritization of a robust, scalable formulation that remains fit for purpose across valency evolution supports a stable late-stage manufacturable drug product.
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