| Autor: |
Anushikha Thakur, Rekha Nagpal, Avik Kumar Ghosh, Deepak Gadamshetty, Sirisha Nagapattinam, Malini Subbarao, Shreshtha Rakshit, Sneha Padiyar, Suma Sreenivas, Nagaraja Govindappa, Harish V. Pai, Ramakrishnan Melarkode Subbaraman |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
Scientific Reports, Vol 11, Iss 1, Pp 1-21 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2045-2322 |
| DOI: |
10.1038/s41598-021-92338-1 |
| Popis: |
Abstract Sequence variants (SV) in protein bio therapeutics can be categorized as unwanted impurities and may raise serious concerns in efficacy and safety of the product. Early detection of specific sequence modifications, that can result in altered physicochemical and or biological properties, is therefore desirable in product manufacturing. Because of their low abundance, and finite resolving power of conventional analytical techniques, they are often overlooked in early drug development. Here, we present a case study where trace amount of a sequence variant is identified in a monoclonal antibody (mAb) based therapeutic protein by LC–MS/MS and the structural and functional features of the SV containing mAb is assessed using appropriate analytical techniques. Further, a very sensitive selected reaction monitoring (SRM) technique is developed to quantify the SV which revealed both prominent and inconspicuous nature of the variant in process chromatography. We present the extensive characterization of a sequence variant in protein biopharmaceutical and first report on control of sequence variants to |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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