Monoclonal Antibodies [Working Title]最新文献

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Analytical Characterization of Monoclonal Antibodies with Novel Fc Receptor-Based Chromatography Technique 新型Fc受体色谱技术对单克隆抗体的分析鉴定

Monoclonal Antibodies [Working Title] Pub Date : 2020-12-31 DOI: 10.5772/INTECHOPEN.95356

A. Chakrabarti, J. Kervinen, E. Müller, Toru Tanaka, Kazuaki Muranaka

{"title":"Analytical Characterization of Monoclonal Antibodies with Novel Fc Receptor-Based Chromatography Technique","authors":"A. Chakrabarti, J. Kervinen, E. Müller, Toru Tanaka, Kazuaki Muranaka","doi":"10.5772/INTECHOPEN.95356","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.95356","url":null,"abstract":"Most clinically approved large biotherapeutics are monoclonal antibodies (mAbs), primarily belonging to immunoglobulin G subclass-1 (IgG1) and, to a lesser extent, IgG2 and IgG4. Glycosylation is the main source of post-translational heterogeneity of mAbs, impacting their drug therapeutic mechanism of action (MOA). Glycosylation is also one of the critical factors in drug product solubility, kinetics, stability and efficacy. Thus, monitoring glycan critical quality attributes (CQAs) is an essential part of any biopharmaceutical development. The binding affinity of an IgG to its cellular Fc receptor (FcR) depends on both its IgG subclass and Fc domain glycosylation pattern. Since composition of the N-glycans also correlates to the Antibody-Dependent Cellular Cytotoxicity (ADCC), the glycosylation pattern needs to be monitored for consistency in potency and efficacy. This applies for the original mAb biologics as well as biosimilars. In this chapter, we present a truly novel way to assess the variances in mAb glycoforms using FcγRIIIa-based affinity chromatography. First, a brief overview of the Fc receptor function is presented. Then, the principle of FcR-based affinity chromatography is explained including how this column’s potential to analyze a variety of mAbs according to their N-glycan content is highly selective and robust. Finally, we provide examples of the FcR column’s potential to improve analytical characterization of mAbs with practical applications such as effective cell line screening, monitoring of glycoengineering, process development and process control in manufacturing.","PeriodicalId":123384,"journal":{"name":"Monoclonal Antibodies [Working Title]","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115033790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Alternative Methods to Animal Use for Monoclonal Antibody Generation and Production 单克隆抗体产生和生产的动物替代方法

Monoclonal Antibodies [Working Title] Pub Date : 2020-12-30 DOI: 10.5772/INTECHOPEN.95485

J. Z. Moraes, Bárbara Hamaguchi, Camila Braggion, Enzo Reina Speciale, Fernanda Beatriz Viana Cesar, Gabriela de Fátima da Silva Soares, J. Osaki, R. Aguiar, T. M. Pereira

{"title":"Alternative Methods to Animal Use for Monoclonal Antibody Generation and Production","authors":"J. Z. Moraes, Bárbara Hamaguchi, Camila Braggion, Enzo Reina Speciale, Fernanda Beatriz Viana Cesar, Gabriela de Fátima da Silva Soares, J. Osaki, R. Aguiar, T. M. Pereira","doi":"10.5772/INTECHOPEN.95485","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.95485","url":null,"abstract":"Monoclonal antibody (mAb) has broad applicability in research, diagnosis, and treatment. After the introduction of hybridoma technology in 1975, the mAb market has increased dramatically, moving a large industry of more than US$ 140 billions in 2020. In 1954, the concept of the 3R’s was proposed and much changed the animal use scenario, including the recent ban on inducing ascites in mice for the production of mAb. In light of this, the generation and production of antibodies had to be reassessed. In this chapter, we present an overview of the main alternative technologies to the use of animals in the generation and production of mAb. Antibody display libraries and in silico modeling are very promising technologies that may provide mAb genetic constructs that, in the sequence, may be expressed on mammalian, bacterial, yeast or plant systems. Although the total replacement of the use of animals in the entire process is not currently feasible, it is possible to find ways to reduce and refine the use of animals in obtaining and producing mAb.","PeriodicalId":123384,"journal":{"name":"Monoclonal Antibodies [Working Title]","volume":"63 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129555992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Emerging Monoclonal Antibodies for the Treatment of Multiple Myeloma 用于治疗多发性骨髓瘤的新兴单克隆抗体

Monoclonal Antibodies [Working Title] Pub Date : 2020-10-30 DOI: 10.5772/intechopen.94196

H. Abramson

引用次数: 1