Characterisation of a chromatographically produced anti-D immunoglobulin product.
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 degrees C.
Stucki
M
M
ZLB Central Laboratory, Blood Transfusion Service SRC, Bern, Switzerland.
Moudry
R
R
Kempf
C
C
Omar
A
A
Schlegel
A
A
Lerch
P G
PG
D005591:Chemical Fractionation; D002852:Chromatography, Ion Exchange; D004340:Drug Contamination; D004355:Drug Stability; D005260:Female; D006386:Hemagglutination Tests; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D012203:Rh Isoimmunization / Q000517:prevention & control; D018029:Rho(D) Immune Globulin / Q000009:adverse effects / Q000097:blood / Q000302:isolation & purification* / Q000494:pharmacology; D014780:Viruses / Q000302:isolation & purification
D018029:Rho(D) Immune Globulin