PROCESS-SCALE PURIFICATION OF IMMUNOGLOBULIN-M CONCENTRATE

An IgM concentrate was purified from Cohn fraction III. Efficiency of euglobin precipitation was shown to be controlled by pH and ionic stre ngth. Prekallikrein activator activity in the product was insignifican t. Overall yield from the octanoic acid supernate and purity of the co ncentrate were 66 +/- 8 (n = 16) and 50 +/- 5% (n = 16), respectively. Solvent-detergent treatment to inactivate lipid-enveloped viruses was demonstrated and implemented into the process. Process studies to con trol residual virucidal agents and C4a generating activity are present ed.