International collaborative study to establish immunoglobulin (anti-D test) BRP batch 1.
1NIBSC, Potters Bar, Herts EN6 3QG, UK.
Pharmeuropa Bio
|February 3, 2007
Summary
This study established European Pharmacopoeia (Ph. Eur.) and US FDA reference preparations for anti-D antibody testing in intravenous immunoglobulin (IGIV). These preparations ensure accurate control of anti-D levels in IGIV products.
Area of Science:
- Immunology
- Pharmacology
- Biotechnology
Background:
- Human normal immunoglobulin for intravenous administration (IGIV) requires precise control of anti-D antibody levels.
- Existing reference materials may not fully meet the stringent requirements for anti-D testing in IGIV.
Purpose of the Study:
- To establish European Pharmacopoeia (Ph. Eur.) and US Food and Drug Administration (FDA) reference preparations for the anti-D antibody test.
- To validate these reference preparations through an international collaborative study.
Main Methods:
- A collaborative study involving 16 laboratories was conducted.
- Candidate positive (IGIV+anti-D) and negative control (IGIV) preparations were compared against World Health Organization (WHO) International Reference Reagents.
- A direct haemagglutination reference method was employed for the assays.
Main Results:
- The candidate IGIV+anti-D and IGIV materials were successfully evaluated.
- The collaborative study provided robust data supporting the suitability of the candidate materials.
Conclusions:
- The assayed materials were granted status as Ph. Eur. and US FDA reference preparations.
- These new reference preparations will enhance the control and accuracy of anti-D antibody testing in IGIV products.
