Development and Certification of a Standard Sample for Determining Anti-D Antibody Contents in Human Immunoglobulin Preparations

Materials for the development and certification of a standard sample for anti-D antibody contents in human immunoglobulin drugs are presented. Preparation of the negative component of the standard sample from blood plasma of Rh-positive group IV(AB) donors without anti-D antibodies; the positive component, from blood plasma of Rh-negative group IV(AB) donors is justified. The immunoglobulin should be concentrated to produce a solution with protein contents in the range 48 – 51 mg/mL and anti-D antibody titer 1:8. Flow cytofluorimetry is shown to allow standardization of the preparation of the standard sample positive component.