Ortho Diagnostic Systems Inc.

Ortho Diagnostics, Inc.

Raymond P Zolton

Paul M Kaplan

John V Padvelskis

Stephen M Autenrieth

Jennifer A Nasser

Histidine-stabilized immunoglobulin preparations and a method for their manufacture are disclosed. The present invention is particularly well suited for stabilization of human gamma globulin (IgG) preparations having a relatively low protein content. Preferred stabilized human gamma globulin preparations comprise about 5 wt-% or less gamma globulin, histidine at a concentration of about 0.025M to about 0.2M, and optionally glycine at a concentration of about 0.05M to about 0.5M. The pH value of the preparations is at least 6.0 but not more than 7.0. A pH value of about 6.4 is most preferred. Conductivity of the preparations is about 2 to about 4 millisiemens at 5.degree. C., preferably about 2.5 to about 3.5 millisiemens at 5.degree. C., and most preferably about 2.7 millisiemens at 5.degree. C.

Histidine stabilized immunoglobulin and method of preparation

Methods for producing from human plasma or serum, human gamma globulin free of hepatitis-B-virus infectivity and products resulting therefrom. Specifically provided are ion exchange resin/buffer systems capable of effectively removing the virus.

Methods for preparation of highly purified, gamma globulins free of

Methods for producing from human serum, human gamma globulin essentially free of HB.sub.s Ag and products resulting therefrom. Specifically provided are ion exchange resin/buffer systems capable of effectively removing HB.sub.s Ag thought to be closely correlated with viral hepatitis type B infectivity. Additional steps can include ultrafiltration to increase reduction of any virus not removed in the column passage as well as the addition of anti-HB.sub.g to substantially eliminate all infectivity.

Methods for preparation of HB.sub.s Ag free gamma globulins

Disclosed is a procedure for conducting anti-thrombin III assays in which the conventional thrombin-anti-thrombin III treatment step is conducted at a pH of 7.9 to 8.5 maintained at the level by a buffer system comprising a buffering amount of N-2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid, N-2-hydroxyethylpiperazine-N'-3-propanesulfonic acid, N-tris-(hydroxymethyl)-methyl-2-amino-ethanesulfonic acid, N-tris-(hydroxymethyl)-methylglycine, or N,N-bis (2-hydroxymethyl)-glycine or a salt thereof. The compositions may also contain bacteriostatic agents.

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Somerville, NJ, United States of America

Raymond P Zolton