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Characterisation of various intravenous immunoglobulin preparations
J L Lundblad1, N Londeree, G Mitra
1Research & Development, Quality Assurance, Cutter Laboratories, Miles Pharmaceutical, Berkeley, California 94701.
Abstract:
Five commercially available immunoglobulin preparations are characterised with regard to molecular weight distribution, immunoglobulin subclass distribution and antibody content. Preparations processed utilising enzymic or chemical modification demonstrate considerable variance of molecular weight species and subclass distribution when compared to native preparations. Similarly, cytomegalovirus and anti-streptolysin O antibody content is dramatically reduced in the modified preparations. Possible reasons for the differences are discussed. In-process inactivation of Human Immunodeficiency Virus is reviewed with regard to one of the native preparations.