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University of Kansas

1. Okbazghi, Solomon Zeray. Comparative Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilar Comparability Analysis.

Degree: PhD, Pharmaceutical Chemistry, 2017, University of Kansas

The patents of several best-selling biologic therapeutic products are expiring soon. Consequently, the interest of developing biosimilar products is growing. A biosimilar product is developed if there are no clinically meaningful differences in terms of safety, efficacy, and purity after evaluating side-by-side with the originator. Biosimilar products are anticipated to be accessible to healthcare providers and patients at a lower cost compared to the originators. Unlike small-molecule generic drug products, which are structurally replicable and well-defined, that guarantee the safety and efficacy, biologic products are structurally complex, larger in size and often contain mixtures of various posttranslational modifications. Consequently, demonstrating the similarity of a biosimilar molecule with the reference product requires extensive characterization to ensure safety and efficay. One of the challenges in developing a biosimilar product is the lack of knowledge about the reference product’s manufacturing process, which is not accessible to the public because it is a proprietary knowledge. Therefore, the biosimilar sponsor needs to develop a process by extensive characterization of a biosimilar candidate side-by-side with a reference product. This is an iterative process aimed at developing a biosimilar molecule similar to the reference product. The first step in biosimilarity assessment is to establish structural similarity by extensive characterization using several analytical techniques. Therefore, analytical tools play a vital role in demonstrating structural similarity as well as process development of a biosimilar candidate. In addition, the level of similarity established by the analytical tools guides the type of non-clinical and clinical data packages required for regulatory approval. If a high degree of similarity is demonstrated using analytical techniques, then phase II clinical trials are not required for registration of a biosimilar candidate. Consequently, this will lower the cost of developing a biosimilar product. Hence, developing sensitive and robust analytical techniques is vital in a biosimilar development process. In this dissertation, four homogeneous glycoforms of IgG1 Fc (HM-Fc, GlcNAc-Fc, Man5-Fc, and N297Q-Fc) were produced using recombinant protein expression combined with in-vitro enzymatic reactions to be utilized as a model for biosimilar comparability analysis. These glycoforms were characterized by mass spectrometry, CIUE, SDS-PAGE, and cIEF. The main focus of the project was to produce homogeneous glycoforms of IgG1 Fc and to utilize them to develop new biolayer interferometry (BLItz) assay methods. Two biolayer interferometry methods with different immobilization techniques were developed to measure the binding affinity of IgG1 Fc glycoforms to FcRIIIa and FcRIIb. In addition, these four glycoforms were mixed in pre-defined composition to examine the characteristics of mixtures of glycoforms and to study important biological and physicochemical features of protein drugs in a… Advisors/Committee Members: Tolbert, Thomas J. (advisor), Volkin, David B (cmtemember), Siahaan, Teruna J (cmtemember), Wang, Michael Z (cmtemember), Ray, Christian J (cmtemember).

Subjects/Keywords: Pharmaceutical sciences; Biosimilar; Comparability analysis; Functional activity; Glycoforms; IgG1 Fc; IgG antibody

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6th Edition):

Okbazghi, S. Z. (2017). Comparative Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilar Comparability Analysis. (Doctoral Dissertation). University of Kansas. Retrieved from http://hdl.handle.net/1808/25387

Chicago Manual of Style (16th Edition):

Okbazghi, Solomon Zeray. “Comparative Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilar Comparability Analysis.” 2017. Doctoral Dissertation, University of Kansas. Accessed April 15, 2021. http://hdl.handle.net/1808/25387.

MLA Handbook (7th Edition):

Okbazghi, Solomon Zeray. “Comparative Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilar Comparability Analysis.” 2017. Web. 15 Apr 2021.

Vancouver:

Okbazghi SZ. Comparative Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilar Comparability Analysis. [Internet] [Doctoral dissertation]. University of Kansas; 2017. [cited 2021 Apr 15]. Available from: http://hdl.handle.net/1808/25387.

Council of Science Editors:

Okbazghi SZ. Comparative Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilar Comparability Analysis. [Doctoral Dissertation]. University of Kansas; 2017. Available from: http://hdl.handle.net/1808/25387

2. 小野, 裕貴. 歯肉溝滲出液中のTannerella forsythia Forsythia Detaching Factor に対する切断酵素活性の治療効果判定への応用 : Application of Proteolytic Activity toward Tannerella forsythia Forsythia Detaching Factor in Gingival Crevicular Fluid to Determination of Therapeutic Effect.

Degree: 博士(歯学), 2015, Meikai University / 明海大学

2014

Subjects/Keywords: Tannerella forsythia; forsythia detaching factor; FC activity; GCF; Tannerella forsythia; forsythia detaching factor; FC activity; GCF

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6th Edition):

小野, . (2015). 歯肉溝滲出液中のTannerella forsythia Forsythia Detaching Factor に対する切断酵素活性の治療効果判定への応用 : Application of Proteolytic Activity toward Tannerella forsythia Forsythia Detaching Factor in Gingival Crevicular Fluid to Determination of Therapeutic Effect. (Thesis). Meikai University / 明海大学. Retrieved from http://id.nii.ac.jp/1216/00000053/

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16th Edition):

小野, 裕貴. “歯肉溝滲出液中のTannerella forsythia Forsythia Detaching Factor に対する切断酵素活性の治療効果判定への応用 : Application of Proteolytic Activity toward Tannerella forsythia Forsythia Detaching Factor in Gingival Crevicular Fluid to Determination of Therapeutic Effect.” 2015. Thesis, Meikai University / 明海大学. Accessed April 15, 2021. http://id.nii.ac.jp/1216/00000053/.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7th Edition):

小野, 裕貴. “歯肉溝滲出液中のTannerella forsythia Forsythia Detaching Factor に対する切断酵素活性の治療効果判定への応用 : Application of Proteolytic Activity toward Tannerella forsythia Forsythia Detaching Factor in Gingival Crevicular Fluid to Determination of Therapeutic Effect.” 2015. Web. 15 Apr 2021.

Vancouver:

小野 . 歯肉溝滲出液中のTannerella forsythia Forsythia Detaching Factor に対する切断酵素活性の治療効果判定への応用 : Application of Proteolytic Activity toward Tannerella forsythia Forsythia Detaching Factor in Gingival Crevicular Fluid to Determination of Therapeutic Effect. [Internet] [Thesis]. Meikai University / 明海大学; 2015. [cited 2021 Apr 15]. Available from: http://id.nii.ac.jp/1216/00000053/.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

小野 . 歯肉溝滲出液中のTannerella forsythia Forsythia Detaching Factor に対する切断酵素活性の治療効果判定への応用 : Application of Proteolytic Activity toward Tannerella forsythia Forsythia Detaching Factor in Gingival Crevicular Fluid to Determination of Therapeutic Effect. [Thesis]. Meikai University / 明海大学; 2015. Available from: http://id.nii.ac.jp/1216/00000053/

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

.