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Immunoglobulin preparation: safe from virus transmission?
Y Uemura1, K Yokoyama, M Nishida
1Research Division, Green Cross Corporation, Osaka, Japan.
Vox Sanguinis
|January 1, 1989
Summary
Hepatitis transmission from intravenous immunoglobulin (IVIG) preparations is a concern. Heat treatment of IgG, a key component of IVIG, improves safety and stability, making it ideal for widespread use.
Area of Science:
- Immunology
- Hepatology
- Biotechnology
Background:
- Non-A, non-B hepatitis transmission has been linked to immunoglobulin preparations.
- Intravenous immunoglobulin (IVIG) preparations were previously considered safe from viral transmission.
- There is a need for enhanced safety in large-volume IVIG administration.
Purpose of the Study:
- To report the incidence of non-A, non-B hepatitis associated with immunoglobulin preparations.
- To investigate methods for improving the safety and stability of IVIG.
- To assess the efficacy of heat treatment for IgG safety.
Main Methods:
- Analysis of hepatitis incidence in patients receiving immunoglobulin.
- Development of a heat treatment protocol for IgG (60°C for 10 hours) under weakly acidic conditions with sorbitol.
- Manufacturing of IVIG using polyethylene glycol fractionation followed by heat treatment.
Main Results:
- The study reports cases of non-A, non-B hepatitis linked to IVIG administration.
- Heat treatment of IgG at 60°C for 10 hours was found to be feasible.
- IVIG manufactured with polyethylene glycol fractionation and heat treatment demonstrated intact IgG and improved safety and stability.
Conclusions:
- Continued research is essential to enhance the safety of IVIG for large-volume administration.
- Heat treatment of IgG is a viable method to improve IVIG safety and stability.
- The developed IVIG preparation is closer to an ideal product regarding safety and stability.