International collaborative study to assess candidate reference preparations to control the level of anti-D in IVIG for use in Europe and the United States

Biologicals

Volumn 34, Issue 3, 2006, Pages 209-212

  Thorpe, Susan J ^a   Fox, Bernard ^a   Heath, Alan ^a   Behr Gross, Marie Emmanuelle ^b   Virata, Maria L ^c   Yu, Mei Ying W ^c  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b European Directorate for the Quality of Medicines   (France)

^c CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Anti Rho; Haemagglutination; Haemolysis; IGIV; Reference preparations; Specification

Indexed keywords

IMMUNOGLOBULIN; RHESUS D ANTIBODY;

ARTICLE; DRUG SYNTHESIS; EUROPE; FOOD AND DRUG ADMINISTRATION; HEMAGGLUTINATION; HUMAN; LABORATORY; LICENCE; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; TITRIMETRY; UNITED STATES; WORLD HEALTH ORGANIZATION;

EUROPE; EVALUATION STUDIES; EVALUATION STUDIES AS TOPIC; HEMAGGLUTINATION TESTS; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; INTERNATIONAL COOPERATION; ISOANTIBODIES; REFERENCE STANDARDS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORLD HEALTH ORGANIZATION;

EID: 33747071825     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2005.11.001     Document Type: Article

References (5)

1. Human normal immunoglobulin for intravenous administration. Monograph 0918 European Pharmacopoeia 5th ed. Suppl. 5.3, p. 3516-8.
2. Test for anti-D antibodies in intravenous immunoglobulin. General chapter 2.6.26. European Pharmacopoeia 5th ed. Suppl. 5.3, p. 3348.
3. Thorpe S.J., Fox B., Heath A., Dolman C., Virata M.L., Yu M.W., et al. International collaborative study to evaluate a candidate reference preparation to define an appropriate specified limit of anti-D in IVIG products. Vox Sanguinis 88 (2005) 278-287
4. Thorpe S.J., Fox B.J., Dolman C.D., Lawrence J., and Thorpe R. Batches of intravenous immunoglobulin associated with adverse reactions in recipients contain atypically high anti-Rh D activity. Vox Sanguinis 85 (2003) 80-84
5. In: Beattie K., Crawford M., Mallory D., and Mougey R. (Eds). American National Red Cross immunohaematology methods and procedures manual (1993) 42