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Methods to monitor oligomeric state of HIV vaccine antigen evaluated.
2004 OCT 6 - (NewsRx.com & NewsRx.net) -- Researchers have evaluated on-line high-performance size-exclusion chromatography, differential refractometry, and multi-angle laser light scattering analysis for the monitoring of the oligomeric state of human immunodeficiency virus vaccine protein antigen.
"Chiron has developed a novel mutant form of the human immunodeficiency virus (HIV) envelop protein, o-gp140, that is currently entering Human Phase I clinical trials for testing as a prophylactic HIV vaccine. The o-gp140 protein is oligomeric and the quaternary structure is thought to play an important role in its activity as an antigen. As o-gp140 proceeds through the clinical trial process and prior to marketing approval, analytical methods that are able to demonstrate manufacturing consistency with respect to degree of oligomerization will need to be developed and validated," investigators in the United States report.
"On-line high-performance size-exclusion chromatography, differential refractometry, and multi-angle laser light scattering analysis (HPSEC-RI-MALLS), a method commonly used to obtain the molar mass of macromolecules based on the Rayleigh-Gans-Debye approximation, was evaluated for this purpose," said John Barackman and colleagues at Chiron Corporation. "The results obtained demonstrated intra- and inter-day precisions to be 0.9 and 3.6% R.S.D., respectively. Accuracy was found to be equal to, or better than, 11% when comparing the known molar masses of test proteins to ...
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Source: HighBeam Research, Methods to monitor oligomeric state of HIV vaccine antigen evaluated.