人血清白蛋白（HSA）中生物分子稳定性检测方案(圆二色光谱仪)

Application Note 2/2JWSQC-530 SpectrumQC Test ProgramApplication Note JWSQC-530 Spectrum QC Test Program Biopharmaceutical and biotech product production is a long processthat entails years of research， development， and clinical trials. Thesephases demand rigorous chemical stability studies for optimizationof dosage and product scale up， as well as suitability of productpackaging. Circular dichroism (CD) is a commonly used techniquein the pharmaceutical and food science industries for structuralcharacterization of biomolecules. Changes in spectral data couldindicate a loss in stability or change in structure， corresponding tcinhibition of the biomolecule's function. Differentiating between true J-1500 CD Spectrometer structural changes， or differences in spectra due to instrument noise or general sample-to-sample variation， should not beleft to the user's discretion. Comparability software allows users to compare and quantify differences between spectra by eliminating operator bias inthese similarity judgements. The JWSQC-530 Spectrum QC Test program statistically evaluates the similarity and z-scorebetween a comparison sample spectrum and reference model. Since CD monitors the difference in the absorption ofleft-and right-handed circularly polarized light， the measured signal is extremely small， to account for noise in the CDspectrum weighted score calculations are performed for each wavelength using the relation between the noise standarddeviation and the high tension (HT) voltage of the CD spectrometer. This application note highlights the features of the Spectrum QC Test program. Keywords Circular dichroism， JWSQC-530， Pharmaceuticals，Biochemistry， Food science， Comparability Features 3 algorithms available for CD： Correlation coefficient， Euclidean distance， Manhattan distance Sensitive to changes in spectral shape and intensity 21 CFR Part 1 Compliant Optical pathlength and concentration correction for reference model and sample spectrum (Figure 1) Pass/fail evaluation function using z-score (Figure 2) Figure 1. Average reference spectrum and correction dialogue box for specifying the weighting parameters in Reference Mode. Figure 2. Comparison of spectra and Euclidean distance analysis results in Compare Mode. JASCO INC.Mary’s Court， Easton， MD USATel： ( Fax：( pplication Library： http：//www.jascoinc.com/applications 本应用说明了如何使用圆二色的光谱质控软件监测HSA的生物分子稳定性，并突出了光谱质控测试程序的特点。