engleski

Monolithic anion-exchange chromatography as a process step for the preparation of a high-quality immunoglobulin G-based product with relevance for emerging virus outbreaks

Today, when epidemics of infectious diseases are occurring more often, and spreading faster and further than ever, there is a great need for a more sustainable production approach that would be goal-oriented towards assuring easily available, effective and safe plasma-derived immunoglobulin of therapeutic relevance. Unlike other therapies, convalescent plasma becomes available as soon as there are survivors, without any need for further development.1-3 Here, we propose a refinement strategy for the preparation of a ready-to-use IgG from COVID-19 convalescent plasma, achieved through simplification and reduction of processing steps. The manufacturing procedure was guided by the idea of persistent keeping of IgG molecules in a solution, so that preservation of their native structure could be assured. Our production approach involves the sequence of only three steps: caprylic acid precipitation of unwanted proteins, diafiltration of immunoglobulin-enriched fraction and CIM® monolithic anion-exchange chromatography under conditions that allow adsorption of IgA, IgM and other residual impurities exclusively, while at the same time enable passing of IgG through the stationary phase without binding. The recovery of IgG was monitored in every processing step, enabling accurate estimation of the procedure's cost-effectiveness. The manufacturing procedure on a small-scale provided a high-quality IgG product of above the average yield, free from IgA and IgM as mediators of adverse transfusion reactions, as well as from any other residual impurities or aggregates. Also, it offers an immediately available treatment option, filling the gap between onset of emerging infectious diseases and development of other specific therapies.

COVID-19 convalescent plasma ; preparation of high-quality immunoglobulin G ; monolithic anion-exchange chromatography

Poster je nagrađen trećom nagradom