Therapeutics purified from pooled blood plasma contain a wide variety of immunoglobulins (Ig) including the blood typing, anti-A and anti-B Ig, that are responsible for adverse hemolysis reactions. A set of resins, called Eshmuno® P anti-A and Eshmuno® P anti-B, have been developed to specifically target removal of anti-A and anti-B isoagglutinin antibodies from plasma. The resins bind the anti-A/B Ig while allowing the target Ig to flow through. The resins typically show higher than 85% removal of these antibodies from a pool having typical isoagglutinin titers (32/64) at challenging loading levels of desired IgG products. Several loading conditions such as pH, ionic strength were found to have an impact on the removal of anti-A and anti-B isoagglutinin antibodies; however, the removal performance was found to be satisfactory for a wide range of pH (4 – 9) and ionic strength values. Typically, the final product was recovered at yields more than 98% in all of the cases investigated. Additionally, the proprietary chemistries of the base bead synthesis and ligand coupling used for manufacturing of the Eshmuno® P products impart exceptional stability at extreme pH conditions typically used for cleaning and sanitization for over 200 cycles, where 1 cycle corresponds to 1 hour of contact time. Stability was observed under both the acidic and basic cleaning/sanitization solutions such as caustic (0.5 M NaOH) as well as benzyl alcohol containing acidic solutions (for example, PAB). Notably, such stability should allow for the Eshmuno® P resins to be used for a large number of cycles, thereby, improving the effective efficiency and cost of use. The foregoing observations will be discussed in detail. Additionally, a method was established that is independent of anti-A and anti-B titers in a given pool to consistently evaluate the performance of the Eshmuno® P resins. The relationship between the output of this method, and anti-A and anti-B isoagglutinin removal capacity will be discussed.

Eshmuno® P anti-A and anti-B: Affinity resins for removal of anti-A and anti-B isoagglutinins

255th National Meeting (2018)

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