Evaluation of an Ion‐Exchange Procedure for Removal of Hepatitis Type B Contamination from Human Gamma Globulin Products

摘要

Abstract.Utilizing a unique human plasma sample that contained extremely high concentrations of hepatitis B surface antigen (HBsAg), we were able in the laboratory to rapidly screen the binding efficiency for HBsAg of various ion‐exchange resins that can be used to purify gamma globulin product from human plasma. ‘Nonrigid’ resins like QAE‐Sephadex and DEAE‐Sephadex showed a high affinity for HBsAg by removing greater than 104of applied challenge. Much lower binding was achieved by ‘rigid’ resins like DEAE‐Sepharose CL‐6B and DEAE‐Spherodex. Also examined were the usefulness of certain auxiliary procedures, special filters and resins, that offer the potential to remove HBsAg. We failed to find any significant removal of the HBsAg, and in some cases large losses of the gamma globulin product occurred. While encouraged by our findings, certain precautions are discussed concerning the conversion from large‐scale production of gamma globulin by the conventional alcohol method to one utilizing chrom