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Identification, characterization and control of a sequence variant in monoclonal antibody drug product: a case study

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...

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Detalles Bibliográficos
Autores principales: Thakur, Anushikha, Nagpal, Rekha, Ghosh, Avik Kumar, Gadamshetty, Deepak, Nagapattinam, Sirisha, Subbarao, Malini, Rakshit, Shreshtha, Padiyar, Sneha, Sreenivas, Suma, Govindappa, Nagaraja, Pai, Harish V., Melarkode Subbaraman, Ramakrishnan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8225904/
https://www.ncbi.nlm.nih.gov/pubmed/34168178
http://dx.doi.org/10.1038/s41598-021-92338-1

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