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Preparation of a Stable Intravenous Gamma‐Globulin: Process Design and Scale‐Up
Author(s) -
Fernandes Peter M.,
Lundblad John L.
Publication year - 1980
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.1980.tb01844.x
Subject(s) - diafiltration , iodoacetamide , ultrafiltration (renal) , chemistry , dithiothreitol , chromatography , biochemistry , membrane , microfiltration , enzyme , cysteine
. Intravenous γ‐globulin has been 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 as well as product characteristics are discussed.