Abstract: Stable, intravenously-administrable immune globulin preparations are stabilized against aggregation and polymerization and rendered isotonic with amino acid(s) and non-ionic detergents, polysorbate and polyethylene glycol. The immunoglobulins are derived from human or animal sources, or from hybridomas. Optional, additional stabilizers include various physiologically-acceptable carbohydrates and salts. Polyvinylpyrrolidone can be used in addition to the amino acid(s). Apart from the immunoglobulin itself, the preparations are otherwise essentially protein free. The preparations are useful in immunotherapy and as diagnostic reagents.

Abstract: A multi-step process for purifying an immune serum globulin fraction from a crude plasma protein fraction involves precipitating non-serum globulin proteins from an aqueous suspension of the crude plasma protein fraction using a protein precipitant, adding a virus-inactivating agent to the clarified immune serum globulin-containing liquid, absorbing the immune serum globulins onto a cation exchange resin and washing non-serum globulin contaminants from the resin, subjecting the eluate to ultrafiltration to concentrate the immune serum globulins and separate them from low molecular weight species, contacting the concentrate with an anion exchange resin to absorb non-serum globulin contaminants, passing the imune-serum globulins through the anion exchange resin under conditions that leave non-serum globulin contaminants bound to the resin, and subjecting the filtrate to a molecular washing step to produce a purified immune serum globulin fraction.