Preparation of a Stable Intravenous Gamma‐Globulin: Process Design and Scale‐Up

Abstract
I.v. .gamma.-globulin was prepared on a pilot scale by the process of reduction with dithiothreitol and alkylation with iodoacetamide. The spent reagents are removed by diafiltration followed by ultrafiltration. The product is stabilized with maltose to minimize precipitation. Process design concepts and product characteristics are discussed.