Affinity Chromatography: Innovative Approach for Enhanced Yield and Purity in Plasma-derived IgG

Traditional methods for producing Intravenous Immunoglobulin (IVIG) have been relying on ethanol precipitation cascades, often demanding compromises in yield and purity. We present a versatile approach utilizing direct adsorption of plasma IgG as well as recovery of IgG from side fractions via affinity chromatography. This innovative technique significantly enhances IgG yield while fulfilling critical quality attributes for therapeutic IVIG. IgG subclass distribution is maintained identical to that found in plasma and the resulting IgG is fully functional and comparable to commercial IVIG preparations, as demonstrated by Fc in-vitro assays. Our method achieves a substantial reduction of impurities such as IgA, IgM, and FXI/FXIa in a single step, thereby streamlining the purification process and improving product quality. Furthermore, the affinity chromatography resin employed in this process can be re-used multiple times, enhancing the cost-effectiveness and sustainability of the method. By eliminating the need for complex and time-consuming ethanol precipitation cascades, our method offers a more efficient and cost-effective alternative for IVIG production. In addition, this technique can further increase yield by affinity capture of IgG from side fractions where it is traditionally lost. This presentation will show details of the process performance, comparative analyses, and the significant advantages of this novel approach.