{"title":"Characterization of Biopharmaceuticals Focusing on Antibody Therapeutics","authors":"W. Kim, K. Kang, J. Suh","doi":"10.5772/INTECHOPEN.79107","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.79107","url":null,"abstract":"Biopharmaceuticals are highly complex molecules and also require high quality for safety and efficacy in human uses. For well-characterized products, the desired level of quality should be monitored and controlled during the manufacturing processes. A series of workflow for analytical characterization should be applied for product quality throughout those processes. In this chapter, several analytical techniques are introduced for assessing characteristics of biopharmaceuticals focusing on monoclonal antibodies (mAbs). Analytical characterization for primary structure was performed by mass spectrometry (MS), and assessment of post-translational modifications (PTMs) was done by conventional approaches. The analytical assessments were also done by multi-attribute method (MAM) approach using mass spectrometer (MS), and the performance of MAM was compared to conventional approaches.","PeriodicalId":8089,"journal":{"name":"Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes","volume":"94 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80893376","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}
G. Sagaradze, P. Nimiritsky, Z. Akopyan, P. Makarevich, A. Efimenko
{"title":"“Cell-Free Therapeutics” from Components Secreted by Mesenchymal Stromal Cells as a Novel Class of Biopharmaceuticals","authors":"G. Sagaradze, P. Nimiritsky, Z. Akopyan, P. Makarevich, A. Efimenko","doi":"10.5772/INTECHOPEN.78605","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.78605","url":null,"abstract":"Regenerative medicine is a fast growing multidisciplinary field aiming at the regeneration or replacement of damaged cells, tissues, or organs. Adult multipotent mesenchymal stro mal cells (MSCs) are often used as a principal therapeutic tool in this field. Along with dif - ferentiation potency, MSCs secrete a wide spectrum of paracrine factors and extracellular vesicles participating in tissue repair and regeneration. Thus, for injuries that require trophic stimulation, cell survival support, and/or resident stem cells activation to be restored, one can apply MSC-conditioned medium, a combination of products and extracellular vesicles in cell culture growth medium, secreted by MSC. It could mediate most of beneficial regen erative effects of MSC without possible side effects of using MSC themselves. However, before the clinical application of this promising biopharmaceutical, several issues such as manufacturing protocols, quality control, and others must be addressed. Subsequently, we","PeriodicalId":8089,"journal":{"name":"Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes","volume":"103 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75601788","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}
C. Schirmer, T. Nussbaumer, R. Schöb, R. Pörtner, Regine Eibl-Schindler, D. Eibl
{"title":"Development, Engineering and Biological Characterization of Stirred Tank Bioreactors","authors":"C. Schirmer, T. Nussbaumer, R. Schöb, R. Pörtner, Regine Eibl-Schindler, D. Eibl","doi":"10.5772/INTECHOPEN.79444","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.79444","url":null,"abstract":"Stirred tank bioreactors are still the predominant cultivation systems in large scale bio- pharmaceutical production. Today, several manufacturers provide both reusable and single-use systems, whereas the broad variety of designs and properties lead to devia- tions in biological performance. Although the methods for bioreactor characterization are well established, varying experimental conditions and procedures can result in sig- nificantly different outcomes. In order to guarantee a reliable comparison and evaluation of different single-use and reusable bioreactor types, standardized methods for their characterization are needed. Equally important is the biological capability of bioreactors, which must be accessed by standardized cultivation procedures of industrially relevant organisms (bacteria, yeasts as well as mammalian and animal cell cultures). In addition, the implementation of well-defined uniform procedures for biological and engineering characterization during the development phase can support a fast assessment of the suitability of a bioreactor system. Based on stirred bioreactors, we describe the aspects of the engineering characterization in order to discuss further the biological characterization as a valuable complement. Finally, a case study is presented.","PeriodicalId":8089,"journal":{"name":"Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82129215","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}