A new intact immunoglobulin for intravenous use stabilized by chemically modified gelatin derivatives

The stabilization of human immunoglobulin (IgG) by chemically modified gelatins (Haemaccel and Gelofusine) was investigated. The gelatins prevented IgG from aggregation induced by exposure to interfaces and lyophilization. The stabilization effects of the gelatins were significantly larger than those of amino acids or sugars. These investigations led to the large-scale production of an immunoglobulin preparation for intravenous use in the clinic. The clinical product meets the Japanese minimum requirements for immunoglobulin preparations for intravenous use, and the long-term preservation of this new freeze-dried preparation has demonstrated its stability.