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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 ***,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 *** 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 *** A total of 91 patients(105 coronary artery vessels)who were admitted from January 2015 to March 2019 were enrolled in this study,*** patients underwent CCTA and invasive FFR.64 patients(75 coronary artery vessels)were successfully *** correlation and diagnostic performance of SF-FFR method on per-vessel basis were analyzed,using invasive FFR as the gold *** a comparison,we also evaluated the correlation and diagnostic performance of *** 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,*** SF-FFR calculation time was about 2.5 s per case while CFD calculation was about 2 min on an Nvidia Tesla V100 graphic *** The SF-FFR method is feasible and shows high correlation compared to the gold *** method could simplify the calculation procedure and save time compared to the CFD method.

关键词： coronary admitted angiography

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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 *** 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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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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Axial Cone Beam Reconstruction with Asymptotic Trajectory Extrapolation Implemented by 3-D Weighting Scheme

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Tsinghua Science and Technology 2010年第1期15卷 114-119页

作者： TANG Xiangyang Department of Radiology,Emory University School of Medicine,Atlanta 30322,USA Computed Tomography and Molecular Imaging,ge healthcare,Waukesha 53188,USA Department of Radiology Emory University School of Medicine Atlanta 30322 USA Computed Tomography and Molecular Imaging GE Healthcare Waukesha 53188 USA

Axial scan along circular trajectory has been the most desirable in clinical and preclinical applications. However, due to the violation of the data sufficiency condition, the reconstruction accuracy of axial scan deteriorates rapidly with increasing detector z-dimension. A number of algorithms have been proposed thus far to improve the reconstruction accuracy. It is well understood that, the larger the radius of circular trajectory the more accurate the reconstruction. Ultimately, the reconstruction becomes accurate if the trajectory radius reaches infinite. Inspired by such observations, an asymptotic weighting scheme is proposed here for axial scan at large cone angles to improve reconstruction accuracy. In practice, there may be other ways to im- plement the asymptotic 3-D weighting scheme, and we present one approach in this paper with preliminary results. Further investigation may enable this asymptotic weighting scheme to improve reconstruction accuracy significantly, enabling numerous applications in which axial scan at large z-dimension is desired.

关键词： computed tomography (CT) cone beam volumetric CT volumetric.CT image reconstruction tomography cone beam reconstruction axial scan

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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 *** 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 *** wanted to

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Evaluation of the AGCU Expressmarker 16 and 22 PCR Amplification Kits Using Biological Samples Applied to FTA Micro Cards in Reduced Volume Direct PCR Amplification Reactions

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Journal of Forensic Science and Medicine 2015年第1期1卷 3-7页

作者： Samantha J Ogden Kathryn L Lamerton Peter J Tatnell R&D Bio-Research ToolsGE Healthcare Life SciencesThe Maynard CentreForest FarmWhitchurchCardiffUK

This study evaluated the performance of the Wuxi AGCU ScienTech Incorporation(HuiShan,Wuxi,China)AGCU Expressmarker 16(EX 16)and 22(EX22)short tandem repeat(STR)amplification kits in reduced reaction volumes using direct polymerase chain reaction(PCR)amplification *** commercially available PowerPlex21(PP21)System(Promega,Wisconsin,USA),which follows similar direct workflows,was used as a *** blood applied to chemically impregnated FTATM Micro Cards(ge healthcare UK Limited,Amersham Place,Little Chalfont,Buckinghamshire,HP79NA,UK)was used to represent a complex biological *** concordance,first‑pass success rate,average peak heights,heterozygous peak height ratios(HPHRs),and intracolor and intercolor peak height balance were *** reduced volume PCR reactions,the performances of both the EX16 and EX22 STR amplification kits were comparable to that of the PP21 *** level of performance was maintained at PCR reaction volumes,which are 40%of that *** EX22 and PP21 System kits possess comparable overlapping genome *** study evaluated the performance of the AGCU EX16 and EX22 STR amplification kits in reduced PCR reaction volumes using direct workflows in combination with whole blood applied to FTATM Micro *** concordance,first‑pass success rate,average peak heights,HPHRs,and intracolor and intercolor peak height balance were determined.A concordance analysis was completed that compared the performance of the EX16 and EX22 kits using human blood applied to FTA Micro Cards in combination with full,half,and reduced PCR reaction *** PP21 System(Promega)was used as a reference *** appropriate,the distributions of data were assessed using the Shapiro‑Wilk *** normally‑distributed data,statistics were calculated using analysis of variance(ANOVA)and for nonparametric data the Wilcoxon/Kruskal‑Wallis test was *** significance was set at P<*** interva

关键词： Direct amplification DNA typing dried blood spots expressmarker(EX) forensic DNA analysis forensic science FTA sample collection cards short tandem repeat(STR)profiling

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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 *** this basis,the structure framework of cleaning robot is proposed,and its system composition is introduced,mainly including mobile mechanism,clamping mechanism and cleaning *** structure has the characteristics of light weight,small size and self-locking without ***/E software is used to complete the modeling of the cleaning ***,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 *** 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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Identification of Colored Dyes that are Resistant to Fading on Exposure to Ethylene Oxide;Use with Indicating FTA™Sample Collection Cards

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Journal of Forensic Science and Medicine 2016年第2期2卷 67-73页

作者： Nina Moran Peter James Tatnell R&D Bio‑Research Tools GE Healthcare Life SciencesThe Maynard CentreWhitchurchCardiffCF147YTUK

Regulatory Standards and Forensic Communities are expressing an expectation for HID products to be certified as“DNA‑free.”Recently,“DNA‑free”status was described for HID‑related products using ethylene oxide(EtO);this gas reduces the presence of amplifiable DNA and causes minimal interference to downstream HID‑analytical *** sample collection,indicating cards,for example,Indicating FTA™(ge healthcare Life Sciences,UK),are used to collect and store buccal cell *** cards contain a dye which changes color on application of a colorless ***“DNA‑free”indicating cards using EtO should not impact the dyes’ability to indicate sample location or the efficacy of the card in downstream HID‑analytical *** study was initiated to identify alternative dyes to those currently used with sample indicating collection *** most promising,dyes when applied to cellulose papers exhibited a uniform color distribution and excellent sample indicating properties even when mixed with chemicals associated with FTA™.When dyed cellulose papers were exposed to EtO,ultraviolet radiation,elevated temperature,and humidity,negligible fading or discoloration was *** presence of these dyes on cellulose papers did not interfere with direct short tandem repeat(STR)*** concordance,first pass success rate,and mean peak heights were comparable to samples applied to Indicating *** samples applied to EtO‑treated dyed cellulose papers and stored>1 month produced full STR profiles of sufficient quality to allow submission to DNA databases,confirming negligible interference from EtO *** alternative sample indicating dyes resist EtO‑mediated fading while fulfilling the Forensic Community’s expectation for“DNA‑free”with negligible impact on collection card performance.

关键词： Ethylene oxide forensic DNA analysis identification of colored dyes Indicating FTA sample collection cards short tandem repeat profiling

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EVALUATION OF SPECTRAL SELECTED PRESS SEQUENCE IN BREAST LESION CHARACTERIZATION

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Chinese Medical Sciences Journal 2006年第4期21卷 265-269页

作者： Hong Lu Pei-fang Liu Run-xian Bao Fei Sun Department of Diagnostic Radiology Tianjin Cancer Hospital Tianjin Medical University Tianjin 300060 Beijing Economic and Technological Development Area GE Healthcare China Beijing 100172

Objective To evaluate the role of ^1H spetral selected point-resolved spectroscopy （SS-PRESS） sequence in distingnishing benign from malignant breast lesions by the malignancy marker of choline peak and to investigate the factors influencing the diagnosis. Methods A total of 131 patients （ aged 24-83 years, average 44. 8 years） were enrolled in this study. The examinations were performed on a 1.5T scanner with four-channel phased array breast coiL Singie-voxel proton magnetic resonance spectroscopy （1H MRS） was acquired by SS-PRESS sequence in these patients referred to surgical or biopsy consultation. Results Among these patients, 74 were proved to have breast carcinomas and 57 have benign lesions by histopathological examinations, Thirty-one elevated choline peaks were observed in these 74 confirmed malignant lesions, and 5 detectable choline peaks were demonstrated in the 57 benign lesions. The sensitivity and specificity of ^1H SSPRESS MRS were 41.9% and 91.2%, respectively. The main factors influencing the diagnosis were signal-to-noise ratio and pathological type. Conclusions ^1H SS-PRESS MRS can provide a noninvasive, biochemical measurement of metabolism and improve the specificity of breast magnetic resonance imaging. Choline peak in vivo is a specific but not sensitive marker of malignancy. Technique factors and histopathological characterization of lesions influence the detection rate.

关键词： magnetic resonance spectroscopy spetral selected point-resolved spectroscopy breastlesion choline pathology

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