Zobrazeno 1 - 10
of 67
pro vyhledávání: '"Izydor Apostol"'
Autor:
Chao-Hsiang Wu, Izydor Apostol, Chetan T. Goudar, Pavel V. Bondarenko, Da Ren, Zhongqi Zhang, David J. Semin
Publikováno v:
Current Opinion in Biotechnology. 71:206-215
Rapid technological advances have significantly improved the capability, versatility, and robustness of mass spectrometers which has led to them playing a central role in the development, characterization, and regulatory filings of biopharmaceuticals
Autor:
Richard Wu, Mee Ko, Jiu-Li Song, Gregory Schlobohm, Wojciech Szpankowski, Izydor Apostol, Lan Li
Publikováno v:
Journal of pharmaceutical sciences. 109(4)
Methods that determine the relative purity of biopharmaceuticals represent the most widely used form of analysis for the pharmaceutical industry. The ability to rapidly assess method capability or the uncertainty of measurements under actual use cond
Publikováno v:
Analytical Chemistry. 89:3562-3567
A significant challenge of traditional glycan mapping techniques is that they do not provide site-specific glycosylation information. Therefore, for proteins containing multiple glycosylation sites, the individual glycan species present at a particul
Autor:
Szilan Fodor, Izydor Apostol, Tian Wang, Suminda Hapuarachchi, Xinzhao Grace Jiang, Kenneth Chen, Gang Huang
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 72:59-64
Protein aggregation was observed in a purification intermediate of a therapeutic Fc-fusion protein stored at -30 °C, even though the protein was stable at 4 and -80 °C. The protein was expressed in Escherichia coli as an inclusion body, refolded, a
Autor:
Drew N. Kelner, Xin Zhang, Dave Meriage, Jette Wypych, Jessica Gastwirt, Leszek Poppe, Wojciech Szpankowski, Szilan Fodor, Suminda Hapuarachchi, Xinzhao Grace Jiang, Kenneth Chen, Frank Ye, Gang Huang, Izydor Apostol
Publikováno v:
Pharmaceutical Research
Purpose To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry. Methods We have conducted a comprehensive survey of purity
Quantification of protein posttranslational modifications using stable isotope and mass spectrometry
Autor:
Shun Luo, Quanzhou Luo, Xinzhao Grace Jiang, Izydor Apostol, Ronald N. Keener, Xin Zhang, Matthew Jerums, Gang Huang, Jette Wypych, Jeffrey Lewis
Publikováno v:
Analytical Biochemistry. 421:506-516
With the increased attention to quality by design (QbD) for biopharmaceutical products, there is a demand for accurate and precise quantification methods to monitor critical quality attributes (CQAs). To address this need we have developed a mass spe
Publikováno v:
Analytical Biochemistry. 388:273-278
Monoclonal antibodies (mAbs) produced from mammalian cell culture may contain significant amounts of dimers and higher order aggregates. Quantitation of soluble aggregates in the cell culture is time-consuming and labor-intensive, usually involving a
Publikováno v:
Analytical Biochemistry. 385:101-106
Several different techniques suggested by the International Conference on Harmonization (ICH) Q2R1 guideline were used to assess the signal and concentration at the limit of detection (LOD) and limit of quantitation (LOQ) for a purity method. These a
Publikováno v:
Protein Science. 18:424-433
Susceptibility of methionine residues to oxidation is a significant issue of protein therapeutics. Methionine oxidation may limit the product's clinical efficacy or stability. We have studied kinetics of methionine oxidation in the Fc portion of the
Publikováno v:
Protein Science. 10:1466-1469
Isotope ratio monitoring (IRM) mass spectrometry was used to measure the relative abundance of stable isotopes in several samples of adult human hemoglobin expressed in E. coli, yeast, and human blood. The results showed significant differences in th