检索结果-南通市图书馆

Detection and quantitation of host cell proteins in monoclonal antibody drug products using automated sample preparation and data-independent acquisition LC-MS/MS

引用

Journal of Pharmaceutical Analysis 2021年第6期11卷 726-731页

作者： Lisa Strasser Giorgio Oliviero Craig Jakes Izabela Zaborowska Patrick Floris Meire Ribeiro da Silva Florian Füssl Sara Carillo Jonathan Bones Characterization and Comparability Laboratory NIBRT-National Institute for Bioprocessing Research and TrainingDublinA94 X099Ireland School of Chemical and Bioprocess Engineering University College DublinDublinD04 V1W8Ireland

Ensuring the removal of host cell proteins(HCPs) during downstream processing of recombinant proteins such as monoclonal antibodies(m Abs) remains a *** residual HCPs might affect product stability or safety,constant monitoring is required to demonstrate their removal to be below the regulatory accepted level of 100 ng/*** current standard analytical approach for this procedure is based on ELISA;however,this approach only measures the overall HCP ***,the use of orthogonal methods,such as liquid chromatography-mass spectrometry(LC-MS),has been established,as it facilitates the quantitation of total HCPs as well as the identification and quantitation of the individual HCPs *** the present study,a workflow for HCP detection and quantitation using an automated magnetic bead-based sample preparation,in combination with a data-independent acquisition(DIA) LC-MS analysis,was *** the same instrumental setup commonly used for peptide mapping analysis of m Abs allows for its quick and easy implementation into pre-existing workflows,avoiding the need for dedicated instrumentation or ***,quantitation of HCPs over a broad dynamic range was enabled to allow monitoring of problematic HCPs or to track changes upon altered bioprocessing conditions.

关键词： Data-independent acquisition Host cell proteins Critical quality attributes Liquid chromatography-mass spectrometry Monoclonal antibody Chinese hamster ovary cells

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

Incorporating Mass Spectrometry into Biologic QC Control Environments for O-Glycan Analysis

Incorporating Mass Spectrometry into Biologic QC Control Env...

引用

第六届生物技术药物理化特性分析与质量研究技术研讨会

作者： Mark Hilliard Ciara A.McManus William Alley Ying Qing Yu John Gebler Pauline M Rudd nibrt Foster AvenueMount MerrionBlackrockCo Dublin Waters Corporation

O-linked glycans are typically more challenging to analyze than N-linked glycans,partly because of the diversity of the core structures as well as the lack of a universal ***,most O-glycan workflows are performed on high-end mass spectrometry instruments which are not available in most QC *** MS instruments do not provide the quantitative data required by the regulators and there can be a lack of skilled personnel to operate *** the emergence of O-glycosylated biotherapeutics,it is now necessary to develop alternative workflows;first a more research focused LC-QTof approach and secondly,a more QC compatible methodology employing a novel mass detector,the *** typically employ chemical techniques for O-linked glycan *** we present a microwave-assisted O-linked glycan release workflow that can be completed within 12-70 minutes in comparison to traditional beta-elimination methods which takes around 16 *** addition of the QDa mass detector allowed for the addition of mass data that is complementary to more traditional optical detectors that are found within the QC ***,we can increase MS sensitivity with the addition of an MS compatible fluorophore which also facilitates the collection of qualitative and quantitative LC-MS data which is not generally represented in current *** more complex samples or where accurate mass and MS/MS data is required,our LC-MS method can be transferred effortlessly to more research orientated instruments such as the QTof-MS.

关键词：

来源： cnki会议评论

在线全文

cnki会议

学校读者我要写书评

暂无评论

Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies

引用

Journal of Pharmaceutical Analysis 2020年第1期10卷 23-34页

作者： Sara Carillo Raquel Peerez-Robles Craig Jakes Meire Ribeiro da Silva Silvia Millan Martín Amy Farrell Natalia Navas Jonathan Bones Characterisation and Comparability Laboratory NIBRT e the National Institute for Bioprocessing Research and TrainingFoster AvenueMount MerrionBlackrockCo.DublinA94 X099Ireland Department of Analytical Chemistry Biohealth Research Institute(ibs.GRANADA)University of GranadaGranadaSpain School of Chemical and Bioprocess Engineering University College DublinBelfieldDublin 4D04 V1W8Ireland

With the size of the biopharmaceutical market exponentially increasing,there is an aligned growth in the importance of data-rich analyses,not only to assess drug product safety but also to assist drug development driven by the deeper understanding of structure/function *** monoclonal antibodies,many functions are regulated by N-glycans present in the constant region of the heavy chains and their mechanisms of action are not completely *** importance of their function focuses analytical research efforts on the development of robust,accurate and fast methods to support drug development and quality *** N-glycan analysis is considered as the gold standard for glycosylation characterisation;however,it is not the only method for quantitative analysis of glycoform *** this study,ten different analytical workflows for N-glycan analysis were compared using four monoclonal *** observing good comparability between the quantitative results generated,it was possible to appreciate the advantages and disadvantages of each technique and to summarise all the observations to guide the choice of the most appropriate analytical workflow according to application and the desired depth of data generated.

关键词： N-Glycans Biopharmaceuticals Monoclonal antibodies Intact mass analysis Mass spectrometry Native mass spectrometry Glycan analysis Peptide mapping Glycopeptide analysis

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

Glycosylation engineering of therapeutic IgG antibodies： challenges for the safety, functionality and efficacy

引用

Protein & Cell 2018年第1期9卷 47-62页

作者： Yusuke Mimura Toshihiko Katoh Radka Saldova Roisin O'Flaherty Tomonori Izumi Yuka Mimura-Kimura Toshiaki Utsunomiya Yoichi Mizukami Kenji Yamamoto Tsuneo Matsumoto Pauline M. Rudd Department of Clinical Research NHO Yamaguchi-Ube Medical Center 685 Higashi-Kiwa Ube 755-0241 Japan Laboratory of Molecular Biology and Bioresponse Division of Integrated Life Science Graduate School of Biostudies KyotoUniversity Kitashirakawa Oiwake-Cho Sakyo-Ku Kyoto 606-8502 Japan nibrt GlycoScience Group National Institute for Bioprocessing Research and Training Mount Merrion Blackrock Dublin 4Ireland Center for Regenerative Medicine Yamaguchi University Graduate School of Medicine 1-1-1 Minami Kogushi Ube 755-8505 Japan Center for Gene Research Yamaguchi University 1-1-1 Minami-Kogushi Ube 755-8505 Japan Research Institute for Bioresources and Biotechnology Ishikawa Prefectural University 1-308 Suematsu Nonoichi Ishikawa 921-8836 Japan

Glycosylation of the Fc region of IgG has a profound impact on the safety and clinical efficacy of therapeutic antibodies. While the biantennary *** oligosaccharide attached to Asn297 of the Fc is essen- tial for antibody effector functions, fucose and outer-arm sugars attached to the core heptasaccharide that gen- erate structural heterogeneity （glycoforms） exhibit unique biological activities. Hence, efficient and quan- titative glycan analysis techniques have been increas- ingly important for the development and quality control of therapeutic antibodies, and g｜ycan profiles of the Fc are recognized as critical quality attributes. In the past decade our understanding of the influence of glycosy- lation on the structure/function of IgG-Fc has grown rapidly through X-ray crystallographic and nuclear magnetic resonance studies, which provides possibili- ties for the design of novel antibody therapeutics. Fur- thermore, the chemoenzymatic glycoengineering approach using endoglycosidase-based glycosyn- thases may facilitate the development of homogeneous IgG glycoforms with desirable functionality as next- generation therapeutic antibodies. Thus, the Fc glycans are fertile ground for the improvement of the safety,functionality, and efficacy of therapeutic IgG antibodies in the era of precision medicine.

关键词： chemoenzymatic glycoengineering crysta structure endoglycosidase fucose glycosylation,intravenous immunoglobulin sialic acid transglycosylation,ultra performance liquid chromatography

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

欢迎您,

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

在线全文

请选择保存的检索档案：

请选择收藏分类：

通借通还

欢迎您,

建议与咨询 留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

在线全文

请选择保存的检索档案： 新增检索档案 确定 取消

请选择收藏分类： 新增自定义分类 确定 取消

通借通还

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

请选择保存的检索档案：

请选择收藏分类：