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Surrogate potency assays:Comparison of binding profiles complements dose response curves for unambiguous assessment of relative potencies

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Journal of Pharmaceutical Analysis 2018年第2期8卷 138-146页

作者： Robert Karlsson Veronica Fridh Asa Frostell Purification and Analysis GE Healthcare Life SciencesUppsalaSweden

Surface plasmon resonance(SPR) systems are widely used for detailed characterization of antibody activities including antigen and Fc-receptor binding. During the later stages of development, where the focus is to ensure that established critical quality attributes(CQAs) are maintained during cell culture,purification and formulation processes, analysis is simplified, and relative potencies are often determined. Here, simulation of binding data revealed that relative potency values, determined via parallel line analysis(PLA) and half maximal effective concentration(EC50) analysis accurately reflect changes in active concentration only if binding kinetics remain unchanged. Changes in the association rate constant shifted dose response curves, and therefore relative potencies, in the same way as changes in analyte concentration do. However, for interactions characterized by stable binding, changes in the dissociation rate constant did not result in any shift, suggesting that this type of change may go unnoticed in the dose response curve. Thus, EC50 and PLA analyses of dose response curves obtained with an anti-TNF-α antibody were complemented with the Biacore functionality for sensorgram comparison analysis, whereby changes in antigen and Fc-receptor binding profiles could be detected. Next, analysis of temperature stressed TNF-α antibody revealed that calibration free concentration analysis(CFCA) data correlated perfectly with relative potency values. Together, these results demonstrate that combinations of SPR based dose response curves, sensorgram comparison and CFCA can be used to strengthen the confidence in relative potency assessments, and suggest that SPR can potentially be used as a surrogate potency assay in the quality control of biotherapeutic medicines.

关键词： Surface plasmon resonance EC50 Sensorgram comparison Calibration free concentration analysis Surrogate potency assay TNF-a

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Novel fast FFR derived from coronary CT angiography based on static first-pass algorithm:a comparison study

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Journal of geriatric Cardiology 2023年第1期20卷 40-50页

作者： Lin YANG Wen-Jia WANG Chao XU Tao BI Yi-ge LI Si-Cong WANG Lei XU Department of Radiology Beijing Anzhen HospitalCapital Medical UniversityBeijingChina GE Healthcare China

BACKGROUND Fractional flow reserve(FFR)is the invasive gold standard for evaluating coronary arterial stenosis.However,there have been a few non-invasive methods such as computational fluid dynamics FFR(CFD-FFR)with coronary CT angiography(CCTA)images that can perform FFR assessment.This study aims to develop a new method based on the principle of static first-pass of CT perfusion imaging technique(SF-FFR)and evaluate the efficacy in direct comparisons between CFD-FFR and the invasive FFR.METHODS A total of 91 patients(105 coronary artery vessels)who were admitted from January 2015 to March 2019 were enrolled in this study,retrospectively.All patients underwent CCTA and invasive FFR.64 patients(75 coronary artery vessels)were successfully analyzed.The correlation and diagnostic performance of SF-FFR method on per-vessel basis were analyzed,using invasive FFR as the gold standard.As a comparison,we also evaluated the correlation and diagnostic performance of CFD-FFR.RESULTS The SF-FFR showed a good Pearson correlation(r=0.70,Pge difference between the SF-FFR and invasive FFR was 0.03(0.11–0.16);between CFD-FFR and invasive FFR was 0.04(-0.10–0.19).Diagnostic accuracy and area under the ROC curve on a per-vessel level were 0.89,0.94 for SF-FFR,and 0.87,0.89 for CFD-FFR,respectively.The SF-FFR calculation time was about 2.5 s per case while CFD calculation was about 2 min on an Nvidia Tesla V100 graphic card.CONCLUSIONS The SF-FFR method is feasible and shows high correlation compared to the gold standard.This method could simplify the calculation procedure and save time compared to the CFD method.

关键词： coronary admitted angiography

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分层分析影像组学模型在肺腺癌诊断中的价值

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放射学实践 2022年第2期37卷 186-194页

作者：黄雪梅孙英丽高盼谭明瑜段绍峰李铭复旦大学附属华东医院放射科上海200040 GE Healthcare

目的:建立并验证可高效鉴别肺腺癌及其浸润程度的预测模型,并根据结节/肿块性质分层分析模型的预测效能。方法:回顾性分析本院2011年10月-2018年12月经病理证实的肺结节/肿块患者2105例。根据肿瘤性质,分为磨玻璃组(A组,1711例)和实性... 详细信息

目的:建立并验证可高效鉴别肺腺癌及其浸润程度的预测模型,并根据结节/肿块性质分层分析模型的预测效能。方法:回顾性分析本院2011年10月-2018年12月经病理证实的肺结节/肿块患者2105例。根据肿瘤性质,分为磨玻璃组(A组,1711例)和实性组(B组,394例),组内以2017年10月为界,分为训练集和测试集。收集患者的传统影像特征、人口统计学资料;采用3D slicer对兴趣区(ROI)进行手动勾画,Pyraodiomics提取影像组学特征,最大相关-最小冗余(mRMR)和最小绝对收缩选择算子(LASSO)算法对特征进行筛选、降维,构建预测模型,并采用受试者操作特征(ROC)曲线及曲线下面积(AUC),校准曲线和拟合优度检验,临床决策曲线分别评价模型的预测准确性、校准度、临床实用性。结果:在A组、B组分别建立独立组学模型、传统模型和融合组学模型。A组:融合组学模型在训练集、测试集、外部验证集的AUC分别为0.92(0.90~0.93)、0.94(0.93~0.96)、0.87(0.82~0.91);B组:融合组学模型在训练集、测试集以及外部验证集的AUC分别为0.85(0.80~0.90)、0.80(0.72~0.89)、0.70(0.54~0.85)。De-long检验A组测试集组学模型与传统模型间效能差异有统计学意义(P<0.05);B组组学模型与传统模型间的效能结果差异无统计学意义。无论是A组还是B组,Hosmer-Lemeshow拟合优度检验融合组学模型、传统模型P值均大于0.05,校准曲线中融合组学模型预测值与标准基线重合度较高。决策曲线中融合组学模型的净利润率最高。该结果在外部验证集中得到部分验证。结论:影像组学进一步提升了传统诊断模式对肺腺癌的诊断效能。相比于实性肺结节/肿块,融合组学模型在磨玻璃肺结节/肿块中的预测准确性、校准度、临床实用性更为优异。

关键词：肺肿瘤肺腺癌影像组学浸润程度,机器学习

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Design and Simulation of Insulator Cleaning Robot via Pro/E and ADAMS

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International Journal of Plant Engineering and Management 2022年第1期27卷 29-38页

作者： CAI Changliang IMG-SGRY-Engineering GE HealthcareBeijing 100176China

Aiming at the complicated cleaning environment of high-voltage substation insulators,the cleaning robot design principles are put for ward.On this basis,the structure framework of cleaning robot is proposed,and its system composition is introduced,mainly including mobile mechanism,clamping mechanism and cleaning mechanism.The structure has the characteristics of light weight,small size and self-locking without motor.Pro/E software is used to complete the modeling of the cleaning robot.Finally,ADAMS is used to establish the simulation model for the cleaning robot,its moving and cleaning process on high-voltage substation insulators is simulated,and the simulation results are analyzed.The results show that the structural design of the cleaning robot is reasonable.

关键词： high-voltage substation insulators cleaning robot Pro/E ADAMS

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疏水层析在去除复合干扰素聚集体中的应用

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中国生物制品学杂志 2014年第1期27卷 129-130页

作者：董敏刘静罗亮解红艳 GE Healthcare Life Sciences

干扰素（interferon，IFN）是一种具有广泛生物活性的调节蛋白质，临床上主要用于抑制病毒的增殖。重组复合干扰素（consensusinterferon，cIFN）是一种完全由人工设计的重组干扰素，是通过对14种天然亚型IFN序列的扫描，利用重组DNA技... 详细信息

干扰素（interferon，IFN）是一种具有广泛生物活性的调节蛋白质，临床上主要用于抑制病毒的增殖。重组复合干扰素（consensusinterferon，cIFN）是一种完全由人工设计的重组干扰素，是通过对14种天然亚型IFN序列的扫描，利用重组DNA技术，将这些亚型IFN蛋白质结构中每一位点上最常见的氨基酸序列排列成一复合序列，再通过基因重组技术在大肠埃希菌中进行表达。

关键词：疏水层析复合干扰素聚集体

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Diffusion kurtosis imaging of microstructural changes in brain tissue affected by acute ischemic stroke in different locations

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Neural Regeneration Research 2019年第2期14卷 272-279页

作者： Liu-Hong Zhu Zhong-Ping Zhang Fu-Nan Wang Qi-Hua Cheng Gang Guo Department of Radiology Xiamen Second Hospital Department of Radiology Xiamen Branch Zhongshan Hospital Fudan University MR Research China GE Healthcare

The location of an acute ischemic stroke is associated with its prognosis. The widely used Gaussian model-based parameter, apparent diffusion coefficient(ADC), cannot reveal microstructural changes in different locations or the degree of infarction. This prospective observational study was reviewed and approved by the Institutional Review Board of Xiamen Second Hospital, China(approval No. 2014002).Diffusion kurtosis imaging(DKI) was used to detect 199 lesions in 156 patients with acute ischemic stroke(61 males and 95 females), mean age 63.15 ± 12.34 years. A total of 199 lesions were located in the periventricular white matter(n = 52), corpus callosum(n = 14), cerebellum(n = 29), basal ganglia and thalamus(n = 21), brainstem(n = 21) and gray-white matter junctions(n = 62). Percentage changes of apparent diffusion coefficient(ΔADC) and DKI-derived indices(fractional anisotropy [ΔFA], mean diffusivity [ΔMD], axial diffusivity [ΔD_a], radial diffusivity ΔDr, mean kurtosis [ΔMK], axial kurtosis [ΔK_a], and radial kurtosis [ΔK_r]) of each lesion were computed relative to the normal contralateral region. The results showed that(1) there was no significant difference in ΔADC, ΔMD, ΔD_a or ΔD_r among almost all locations.(2) There was significant difference in ΔMK among almost all locations(except basal ganglia and thalamus vs. brain stem; basal ganglia and thalamus vs. gray-white matter junctions; and brainstem vs. gray-white matter junctions.(3) The degree of change in diffusional kurtosis in descending order was as follows: corpus callosum > periventricular white matter > brainstem > gray-white matter junctions > basal ganglia and thalamus > cerebellum. In conclusion, DKI could reveal the differences in microstructure changes among various locations affected by acute ischemic stroke, and performed better than diffusivity among all groups.

关键词： nerve regeneration apparent diffusion coefficient diffusion weighted imaging diffusion kurtosis imaging acute ischemic stroke mean kurtosis microstructure changes white matter 1.5 Tesla magnetic resonance system neural regeneration

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Swept-Volume Display System Based on Cylindrical Space Projection and Curved Reflectors

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Journal of Donghua University(English Edition) 2015年第4期32卷 672-676,694页

作者：田丰汪浩夏雪张文俊王鹤 School of Film & TV Arts and Technology Shanghai University Applied Science Lab in GE Healthcare

In order to achieve a clear and steady swept-volume display,the method of swept-volume display based on cylindrical space projection was presented. One projector generated the image volume in π× 70 mm × 70 mm × 150 mm space. Experimentally,the resolution of images was 800 pixel × 600 pixel × 360 pixel,which resulted in almost 345 million voxels. In order to achieve space voxels with uniform brightness, curved reflectors were also designed. In addition,the match conditions between triangles and the scanning planes in the volume space were classified and a sweptvolume graphics engine based on embedded platform was designed.The image rendering the hardware foundation for three-dimensional( 3D) dynamic images generation was achieved. Demonstrated in the experiments,light source utilization of the second-generation system based on curved mirror is about three times brighter than the firstgeneration 3D minitor based on flat mirror,and this system is able to display color,clear and well-proportioned 3D images in brighter room light.

关键词： three-dimensional(3D) display swept-volume display cylindrical space voxel

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基于高分辨率T_(2)WI的影像组学列线图预测直肠癌脉管侵袭的研究

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中国临床医学影像杂志 2021年第7期32卷 500-505页

作者：张益飞李月玥杨彦松龚海鹏郑桂华葛亚琼南通市肿瘤医院江苏南通226000 GE Healthcare 上海210000

目的:探讨高分辨率MR影像组学列线图预测直肠癌脉管侵袭(LVI)的价值。方法:回顾性入组本院2016年12月—2019年12月的直肠癌患者140例,选取病灶最大截面的斜轴位勾画病灶,提取影像组学特征。采用最大相关最小冗余对影像组学特征进行初步... 详细信息

目的:探讨高分辨率MR影像组学列线图预测直肠癌脉管侵袭(LVI)的价值。方法:回顾性入组本院2016年12月—2019年12月的直肠癌患者140例,选取病灶最大截面的斜轴位勾画病灶,提取影像组学特征。采用最大相关最小冗余对影像组学特征进行初步筛选,然后进行LASSO回归分析降维,计算影像组学标签。单因素和多因素Logistic回归分析临床特征、MR影像表现、影像组学标签与LVI的关系并构建预测LVI的模型。结果:LVI发生率约20.7%(29/140),LVI组和无LVI组两组间年龄((61.7±11.7)vs(65.8±9.6),P=0.049)、组织学分级(9/83/19 vs 8/19/2,P=0.011)、磁共振肿瘤T分期(79/32 vs 19/19,P<0.001)、磁共振肿瘤N分期(72/39 vs 11/18,P=0.011)、环周切缘状态(27/84 vs 14/15,P=0.020)、壁外血管侵犯状态(21/90 vs16/13,P<0.001)有统计学差异,余指标无统计学差异。最终预测LVI的列线图包括年龄、组织学分级、磁共振肿瘤T分期、影像组学标签,训练集曲线下面积(AUC)=0.84(95%CI:0.73~0.94),验证集AUC=0.81(95%CI:0.62~1.00)。结论:基于高分辨率MR影像组学列线图能较好的预测直肠癌LVI。

关键词：直肠肿瘤磁共振成像

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最新“美国防治骨质疏松症医师指南”解读

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中国骨质疏松杂志 2008年第5期14卷 371-375页

作者：周琦周建烈 GE Healthcare Technologies Asia PCD200336 Wyeth Consumer healthcare China

美国NOF联同美国医学会等9家学术团体制定了最新"美国防治骨质疏松症医师指南",经循证医学论证,建议:①确保足量钙和维生素D摄入;②定期的负重和肌肉强化运动,减少跌倒风险;③骨密度检测对象:所有65岁以上妇女;有危险因素的较年轻绝经... 详细信息

美国NOF联同美国医学会等9家学术团体制定了最新"美国防治骨质疏松症医师指南",经循证医学论证,建议:①确保足量钙和维生素D摄入;②定期的负重和肌肉强化运动,减少跌倒风险;③骨密度检测对象:所有65岁以上妇女;有危险因素的较年轻绝经后妇女和65岁以上男性;有脆性骨折的绝经后妇女;④骨质疏松症治疗的指征;⑤治疗的药物。我们建议:中国医师可以参考这个指南,结合实际情况,检测骨密度,评估风险因素,识别高危人群,防治骨质疏松症和骨质疏松性骨折。

关键词：骨质疏松症骨质疏松性骨折预防治疗

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1D LC Pre-fractionation of Samples pre-labeled with Cy Dyes prior to Difference gel Electrophoresis (DIge)

1D LC Pre-fractionation of Samples pre-labeled with Cy Dyes ...

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第二届全国植物蛋白质组学学术研讨会

作者： Viola C.Ruddat Phil Beckett Christine R.Rozanas G.Reid Asbury GE Healthcare Biosciences Sunnyvale CA GE Healthcare Biosciences Piscataway NJ

Introduction: Two common challenges in proteomics are sensitivity and resolving power.The technique of 2Delectrophoresis is still superior to other methods in this respect. However,there is still the possibility that some proteins will co-migrate,producing misleading results in both quantitative analysis and identification.We wanted to

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