FOR THE PAST 40 YEARS, CLINICAL IMMUNE GLOBULIN AND ALBUMIN HAVE BEEN ISOLATED FROM PLASMA OR CRYOSUPERNATANT BY THE COLD ETHANOL PROCEDURE THROUGHOUT THE WORLD.

FOR THE PAST 40 YEARS, CLINICAL IMMUNE GLOBULIN AND ALBUMIN HAVE BEEN ISOLATED FROM PLASMA OR CRYOSUPERNATANT BY THE COLD ETHANOL PROCEDURE THROUGHOUT THE WORLD. BECAUSE OF THE EXCELLENT RECORDS OF SAFETY AND EFFICACY OF THESE TWO PRODUCTS, IT IS SAFE TO ASSUME THAT, IN THE FORESEEABLE FUTURE, THE COLD ETHANOL PROCEDURE WILL REMAIN AS THE METHOD OF CHOICE FOR MANUFACTURING THESE PLASMA DERIVATIVES. ANY NEW OR MODIFIED PROCEDURE TO ISOLATE THESE TWO IMPORTANT PLASMA DERIVATIVES WILL HAVE TO BE BUILT INTO THE EXISTING SCHEME OF THE ETHANOL FRACTIONATION. IMPROVEMENTS HAVE BEEN MADE THROUGH THE YEARS TO SHORTEN THE PROCESSING STEPS WITH COMPARABLE YIELD AND QUALITY OF THE PRODUCTS, BUT THE LIQUID-SOLID SEPARATION OF EVERY STEP IS STILL BEING DONE BY CENTRIFUGATION, WHICH IS LABOR INTENSIVE AS WELL AS COSTLY FOR MAINTENANCE, AND IS OFTEN THE BOTTLENECK OF THE ENTIRE PROCESS. THE ULTIMATE OBJECTIVE OF THIS RESEARCH PROPOSAL IS TO ADDRESS THE SIMPLIFICATION OF THE PROCESS, AND THE INCREASE IN YIELD, BASED ON A SIMPLIFIED VERSION OF THE COLD ETHANOL PROCEDURE, TO PREPARE ALBUMIN AND IMMUNE GLOBULIN USING EXCLUSIVELY FILTRATION AND ULTRAFILTRATION TECHNIQUES. FILTRATION WILL BE ATTEMPTED TO REPLACE ALL THE EXISTING CENTRIFUGATION STEPS, AND ULTRAFILTRATION WILL BE ATTEMPTED TO REPLACE LYOPHILIZATION AND RECONSTITUTION TO PREPARE THE FINAL SOLUTIONS. PRELIMINARY RESULTS HAVE INDICATED THAT THIS SIMPLIFIED PROCESS WILL NOT ONLY RESULT IN A PREPARATION WHICH IS AT LEAST OF THE SAME QUALITY AS THAT OBTAINED BY THE CONVENTIONAL FRACTIONATION, BUT ALSO IMPROVE THE YIELD DUE TO FEWER FRACTIONATION STEPS. THIS WILL RESULT IN FEWER HANDLING LOSSES, AND THE ABILITY TO RECOVER THE MOTHER LIQUID WHICH IS OTHERWISE ENTRAPPED IN THE PRECIPITATE.