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Full validation of therapeutic antibody sequences by middle-up mass measurements and middle-down protein sequencing
The regulatory bodies request full sequence data assessment both for innovator and biosimilar monoclonal antibodies (mAbs). Full sequence coverage is typically used to verify the integrity of the analytical data obtained following the combination of multiple LC-MS/MS datasets from orthogonal proteas...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966597/ https://www.ncbi.nlm.nih.gov/pubmed/26760197 http://dx.doi.org/10.1080/19420862.2015.1128607 |