Characterisation of a chromatographically produced anti-D immunoglobulin product |
| |
Authors: | Martin Stucki Radmila Moudry Christoph Kempf Adames Omar Andreas Schlegel and Peter G Lerch |
| |
Institution: | ZLB Central Laboratory, Blood Transfusion Service SRC, CH-3000, Bern 22, Switzerland |
| |
Abstract: | A chromatographic fractionation method has been developed for the production of a liquid-stable anti-D immunoglobulin product for intravenous and intramuscular use. An immunoglobulin fraction, highly enriched with anti-D immunoglobulins, was isolated by cation-exchange column chromatography and further polished, first by anion-exchange chromatography, followed by an aluminium hydroxide gel treatment. The process includes two specific steps for virus inactivation and removal, namely S/D treatment and nanofiltration. The overall anti-D process yield is about 56%. The final product is stabilised with human albumin and glycine and placed in ready-to-use syringes. The anti-D product was shown to be stable in liquid state for at least 30 months at 4°C. |
| |
Keywords: | Nanofiltration Anti-D immunoglobulin Hyperimmunoglobulin |
本文献已被 ScienceDirect 等数据库收录! |
|