Preparation-free method can enable rapid surfactant screening during industrial processing of influenza vaccines.

摘要: Abstract Triton X-100 (TX-100) is the most common surfactant used to split viruses during production of influenza split-virus vaccines. It a mild not known denature viral proteins; this property makes TX-100 useful for maintaining antigen conformational structure, and, as an added benefit, partially stabilizing vaccine formulations against protein aggregation. Despite its benefits, needs be filtered out after virus splitting has been achieved, due toxicity in large quantities. Accordingly, residual presence implications both formulation stability and safety, necessitating accurate screening processing guide decision-making about filtration repeats quantitation final product. Accurate HPLC-based methods are successfully latter but their use routine far from ideal because they often require extensive sample preparation fairly slow, complicated costly. Here, “deconstruction” UV–Vis absorption spectra into components corresponding different absorbing “species” demonstrated novel viable method samples industrial steps. This more importantly, preparation-free, rapid, simple/user-friendly comparatively inexpensive. evaluated depth terms applicability conditions, limitations potential high-throughput adaptation well generalization other complex biopharmaceutical formulations.