engleski

Efficient and sustainable platform for preparation of a high-quality immunoglobulin G as an urgent treatment option during emerging virus outbreaks

During the pre-vaccine era of the COVID-19 pandemic convalescent plasma (CP) has once again emerged as a potential therapeutic form. But, there is a growing concern that variable concentration of neutralizing antibodies, present in CP which originates from different donors, affects its effectiveness. The drawback can be overcome through the downstream process of immunoglobulin fraction purification into a standardized product of improved safety and efficacy. All modern procedures are lengthy processes. They are also based on fractionation of large plasma quantities whose collection is not attainable during an epidemic. When outbreaks of infectious diseases are occurring more frequently, there is a need for a more sustainable production approach that would be goal-oriented towards assuring easily and readily available immunoglobulin of therapeutic relevance. We proposed a simple strategy for the IgG preparation. It was designed as a small but scalable process to offer an immediately available treatment option that would simultaneously be harmonized with an increased CP availability over the viral outbreak time-course. The proof of concept was demonstrated on anti-SARS-CoV-2 plasma but is likely applicable to any other type depending on the current needs. Our procedure provided a high-quality IgG product of above the average recovery. It was proved free from IgA and IgM as mediators of adverse transfusion reactions, as well as of any other residual impurities. Undisturbed IgG subclass composition was accomplished. However, the fractionation principle affected the final product's capacity to neutralize SARS-CoV-2 infectivity. Decrease in neutralization potency significantly correlated with the IgM amount in the CP.

convalescent plasma processing ; polyclonal anti-COVID-19 IgG ; IgG subclass ; passive immunotherapy ; wild-type SARS-CoV-2 neutralization assay ; caprylic acid precipitation ; ion-exchange chromatography ; mass spectrometry

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