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多糖基化位点抗体药物质控中基于单四级杆的多属性分析方法开发与验证
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作者 王福贵 刘涛 +15 位作者 李锦豪 徐梦娇 付蓉蓉 赵香 聂爱英 宋兰坤 陈熙 冀芦沙 钱卫珠 侯盛 李军 徐忠升 范文强 张大鹏 徐进 郭清城 《聊城大学学报(自然科学版)》 2024年第5期169-182,共14页
抗体药物已经成为生物制品的重要组成部分,此类产品具有复杂的质量属性,尤其是具有多糖基化位点的抗体药物,其质量控制面临更高挑战。虽然基于高分辨质谱的多属性分析方法(Multi-attribute method,MAM)已在抗体药物的质控中获得应用,但... 抗体药物已经成为生物制品的重要组成部分,此类产品具有复杂的质量属性,尤其是具有多糖基化位点的抗体药物,其质量控制面临更高挑战。虽然基于高分辨质谱的多属性分析方法(Multi-attribute method,MAM)已在抗体药物的质控中获得应用,但针对多糖基化位点抗体药物的快速且简便的检测技术仍较为少见。开发一种基于单四级杆的多属性分析方法,对于提升这类药物的质控效率具有重要意义。本研究以双糖基化位点的治疗类单抗CMAB009为模型。通过基于高分辨质谱的MAM对其进行了深入的预表征分析,成功获取了其主要质量属性。随后将预表征信息用于基于单四级杆的MAM开发。该方法在单次分析中有效监测了多种产品质量属性,其准确性通过基于高分辨质谱的方法进行了确认。随后我们对该方法进行了严格的方法学验证。验证结果显示,该方法具有良好的专属性、线性、准确度以及精密度等。基于单四级杆的MAM不仅有效地解决了多糖基化位点单抗药物的多属性检测难题,还展示了一定的方法普适性,为不同糖基化位点抗体药物的质量控制提供了一种新的、简便的技术方案。本研究结果预计将推动相关技术平台的改进和理念的更新,从而增强产品开发和质控的整体能力。 展开更多
关键词 抗体药物 多属性分析方法 质量控制 CMAB009 单四级杆
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多属性分析方法应用于治疗类抗体药物质量控制的考量与前景 被引量:4
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作者 汪泓 徐进 +5 位作者 尹红锐 徐明明 凌今 郭怀祖 邵泓 陈钢 《药学学报》 CAS CSCD 北大核心 2020年第9期2092-2098,共7页
近年来,包括治疗类抗体在内的治疗类蛋白产品已成为现代生物制药的主力军。然而,此类产品具有复杂的产品质量属性,在一定程度上限制了产品的研发与质控(quality control,QC)。随着高分辨质谱技术的发展,基于质谱的多属性分析(multi-attr... 近年来,包括治疗类抗体在内的治疗类蛋白产品已成为现代生物制药的主力军。然而,此类产品具有复杂的产品质量属性,在一定程度上限制了产品的研发与质控(quality control,QC)。随着高分辨质谱技术的发展,基于质谱的多属性分析(multi-attribute method,MAM)具有多种产品质量属性的直接检测以及杂质的鉴别能力,其在产品的研发及QC中的重要作用逐渐显现。鉴于MAM有助于促进药品质量及QC水平提升、生产成本降低,为了探索MAM在研发和QC中的应用,本文从MAM的基本流程、在生物制药领域研发与QC中的应用、FDA对MAM在QC中应用的考量以及面临的机遇与挑战进行了介绍。以期为MAM在我国治疗类抗体药物中的应用提供思路,并为其在QC中更好的开发、使用、替代传统方法奠定基础。 展开更多
关键词 质谱技术 多属性分析方法 治疗类抗体药物 质量控制 应用前景
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小型模块化钍基熔盐堆防核扩散性能初步定量评估 被引量:2
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作者 马玉雯 陈金根 +5 位作者 蔡翔舟 伍建辉 李晓晓 余呈刚 邹春燕 杨璞 《原子能科学技术》 EI CAS CSCD 北大核心 2018年第11期1994-2000,共7页
核能的和平利用一直备受关注,防核扩散性能也是评价4代堆性能的4大指标之一,为建立满足4代堆核能系统标准的钍基熔盐堆核能系统,需对其防核扩散性能进行评价。因此,本文基于美国橡树岭国家实验室等机构提出的多属性效用分析(MAUA)方法,... 核能的和平利用一直备受关注,防核扩散性能也是评价4代堆性能的4大指标之一,为建立满足4代堆核能系统标准的钍基熔盐堆核能系统,需对其防核扩散性能进行评价。因此,本文基于美国橡树岭国家实验室等机构提出的多属性效用分析(MAUA)方法,从材料性质、操作需求等14个方面,定量化评估了3种模式下小型模块化熔盐堆卸料的防核扩散性能,并与采用一次通过燃料循环的PWR进行对比,进而为燃料循环方案的优化提供核扩散风险参考。分析结果表明,小型模块化熔盐堆设计防核扩散性能指标——核安全测量值约为0.8,可比拟一次通过燃料循环的PWR,优于闭循环的CANDU堆。此外,本文还针对第3种连续后处理模式堆型的防核扩散性能进行了初步优化。以上分析结果可为进一步合理优化防核扩散性能提供参考,为燃料循环的选择提供合理、透明、可追溯的依据。 展开更多
关键词 防核扩散性能 小型模块化钍基熔盐堆 钍铀循环 多属性效用分析方法
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Alunite processing method selection using the AHP and TOPSIS approaches under fuzzy environment 被引量:3
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作者 Alizadeh Shahab Salari Rad Mohammad Mehdi Bazzazi Abbas Aghajani 《International Journal of Mining Science and Technology》 SCIE EI CSCD 2016年第6期1017-1023,共7页
Alunite is the most important non bauxite resource for alumina. Various methods have been proposed and patented for processing alunite, but none has been performed at industrial scale and no technical,operational and ... Alunite is the most important non bauxite resource for alumina. Various methods have been proposed and patented for processing alunite, but none has been performed at industrial scale and no technical,operational and economic data is available to evaluate methods. In addition, selecting the right approach for alunite beneficiation, requires introducing a wide range of criteria and careful analysis of alternatives.In this research, after studying the existing processes, 13 methods were considered and evaluated by 14 technical, economic and environmental analyzing criteria. Due to multiplicity of processing methods and attributes, in this paper, Multi Attribute Decision Making methods were employed to examine the appropriateness of choices. The Delphi Analytical Hierarchy Process(DAHP) was used for weighting selection criteria and Fuzzy TOPSIS approach was used to determine the most profitable candidates. Among 13 studied methods, Spanish, Svoronos and Hazan methods were respectively recognized to be the best choices. 展开更多
关键词 Alunite Mineral processing methods Multi Attribute Decision Making Delphi Analytical Hierarchy Process (DAHP)Fuzzy TOPSIS
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Multi-objective optimization for deepwater dynamic umbilical installation analysis 被引量:6
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作者 YANG HeZhen WANG AiJun LI HuaJun 《Science China(Physics,Mechanics & Astronomy)》 SCIE EI CAS 2012年第8期1445-1453,共9页
We suggest a method of multi-objective optimization based on approximation model for dynamic umbilical installation. The optimization aims to find out the most cost effective size, quantity and location of buoyancy mo... We suggest a method of multi-objective optimization based on approximation model for dynamic umbilical installation. The optimization aims to find out the most cost effective size, quantity and location of buoyancy modules for umbilical installation while maintaining structural safety. The approximation model is constructed by the design of experiment (DOE) sampling and is utilized to solve the problem of time-consuming analyses. The non-linear dynamic analyses considering environmental loadings are executed on these sample points from DOE. Non-dominated Sorting Genetic Algorithm (NSGA-II) is employed to obtain the Pareto solution set through an evolutionary optimization process. Intuitionist fuzzy set theory is applied for selecting the best compromise solution from Pareto set. The optimization results indicate this optimization strategy with approximation model and multiple attribute decision-making method is valid, and provide the optimal deployment method for deepwater dynamic umbilical buoyancy modules. 展开更多
关键词 multi-objective optimization approximation model DECISION-MAKING dynamic umbilical
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Maintenance Decision Making Model with Multiple Attribute Optimization
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作者 蔡志强 李洋 +1 位作者 张帅 周文宝 《Journal of Shanghai Jiaotong university(Science)》 EI 2016年第4期499-503,共5页
An effective maintenance schedule can largely improve productivity and reduce maintenance costs for enterprises. Many factors, such as resource, production, cost and crew, should be considered when we make maintenance... An effective maintenance schedule can largely improve productivity and reduce maintenance costs for enterprises. Many factors, such as resource, production, cost and crew, should be considered when we make maintenance plans. However, it is difficult to meet all requests of the production targets in practical engineering.The multiple attribute decision making for equipment maintenance is proposed in this paper, and the multiple objectives decision making method is utilized to solve the problem in the maintenance process. In the particular environment and resources, a case is studied to illustrate the model and methods. The model gives the optimal maintenance plan with the analytic hierarchy process method in accordance with the particular criteria. It has been proved that this model and decision methods are scientific and operable. 展开更多
关键词 MODEL maintenance decision making multiple attribute WEIGHT
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