Development of Glycoanalytical Methods for Characterization of Biosimilar Monoclonal Antibodies
| dc.contributor.advisor | Schiel, John | |
| dc.contributor.advisor | Boyd, Ann | |
| dc.contributor.advisor | Laufer, Craig | |
| dc.contributor.author | Yandrofski, Katharina | |
| dc.contributor.department | Biology | en_US |
| dc.contributor.program | Biomedical Science | en_US |
| dc.date.accessioned | 2019-12-09T17:17:44Z | |
| dc.date.available | 2019-12-09T17:17:44Z | |
| dc.date.issued | 2019-12-12 | |
| dc.description | Thesis submitted in partial satisfaction of the requirements for the degree of Master of Science in Biomedical Science in the Graduate School of Hood College. I do authorize Hood College to lend this thesis, or reproductions of it, in total or in part, at the request of other institutions or individuals for the purpose of scholarly research. NIST Disclaimer: Values reported herein were collected during NISTmAb qualification and/or certification and current at the time of publication. Users should always refer to the Report of Investigation for their specific material lot for the most up to date values and uncertainty ranges. Certain commercial equipment, instruments, or materials are identified to adequately specify the experimental procedure. Such identification does not imply recommendation or endorsement by the National Institute of Standards and Technology, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose. | en_US |
| dc.description.abstract | Monoclonal antibodies are the fastest growing class of therapeutics with more than $100 billion in yearly revenue. Many of the world’s top selling biotherapeutic mAbs will lose their patent protection by the end of 2019 and a large number of biosimilars are emerging. Detailed characterization of physiochemical and biophysical attributes, such as glycosylation and aggregation, are of critical importance to their safety and efficacy are critical to establishing analytical similarity. Herein we describe development of three analytical assays; size exclusion chromatography (SEC), intact mass spectrometry, and released glycan analysis using the NISTmAb Reference Material – an open innovation tool for the development of innovative analytical approaches. These analytical methods were then applied to a series of non-originator cell lines expressing the NISTmAb that were developed as a pre-competitive biosimilarity test case. The analytical methods and dataset provide the foundational infrastructure for continued development of this resource for the biopharmaceutical community. | en_US |
| dc.description.uri | https://www.tandfonline.com/doi/full/10.1080/19420862.2018.1486355 | en_US |
| dc.format.extent | 111 Pages | en_US |
| dc.genre | Thesis | en_US |
| dc.identifier | doi:10.13016/m2oam8-mse7 | |
| dc.identifier.citation | Kashi L, Yandrofski K, Preston RJ, Arbogast LW, Giddens JP, Marino JP, Schiel JE, Kelman Z. 2018. Heterologous recombinant expression of non-originator nistmab. mAbs. 10(6):922-933. | en_US |
| dc.identifier.uri | 10.1080/19420862.2018.1486355 | |
| dc.identifier.uri | http://hdl.handle.net/11603/16681 | |
| dc.language.iso | en_US | en_US |
| dc.publisher | mAbs | en_US |
| dc.relation.isAvailableAt | Hood College | |
| dc.subject | Biopharmaceutical | en_US |
| dc.subject | Biosimilar | en_US |
| dc.subject | Biotherapeutic | en_US |
| dc.subject | Mass Spectrometry | en_US |
| dc.subject | Monoclonal Antibody | en_US |
| dc.subject | NISTmAb | en_US |
| dc.title | Development of Glycoanalytical Methods for Characterization of Biosimilar Monoclonal Antibodies | en_US |
| dc.title.alternative | Heterologous Recombinant Expression of Non-Originator NISTmAb | en_US |
| dc.type | Text | en_US |