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Pappu Ramesh Jabbour Serge A. Reginato Anthony M. Reginato Antonio J. 《Clinical rheumatology》2017,36(3):735-735
Clinical Rheumatology - 相似文献
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Ashwinkumar A. Bhirde Meng-Jung Chiang Ramesh Venna Serge Beaucage Kurt Brorson 《Journal of pharmaceutical sciences》2018,107(8):2055-2062
Stability of therapeutic proteins (TPs) is a critical quality attribute that impacts both safety and efficacy of the drug. Size stability is routinely performed during and after biomanufacturing. Dynamic light scattering (DLS) is a commonly used technique to characterize hydrodynamic size of the TPs. Herein, we have developed a novel method to evaluate in-use and thermal stress stability of TPs using algorithm-driven high-throughput DLS. Five marketed TPs were tested under the guidance of customized algorithms. The TPs were evaluated at relevant temperature conditions as well as under dilution and thermal stress for size stability. We found that the TPs were stable under the in-use conditions tested; however, sample loss due to evaporation can lead to large protein aggregates. A combined assessment of autocorrelation function and photos of sample well could be useful in formulation screening. Dilution of TPs also has an impact on the hydrodynamic size. Thermal stress experiments showed the importance of using different data processing methods to access size distribution. Polydispersity index was useful in evaluating sample heterogeneity. Herein, we show that algorithm-driven high-throughput DLS can provide additional supportive information during and after biomanufacturing and the potential to be used in a quality control environment. 相似文献
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Previous studies have investigated the effect of ageing on age estimation from faces as well as the occurrence of an own-age bias in such age estimation from faces. To the best of our knowledge, the occurrence of an own age effect on age estimation from voices has never been examined earlier using an experimental design in which the age of participants (young vs. old) and the age of voice stimuli (young vs. old) were crossed. Results revealed an own-age bias in older adults only. In comparison with younger adults, older participants showed age estimation abilities that are preserved for voices from their own age group and impaired for younger voices. This own age bias was absent in younger participants. 相似文献