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Assessing monoclonal antibody product quality attribute criticality through clinical studies
Recombinant therapeutic proteins, including antibodies, contain a variety of chemical and physical modifications. Great effort is expended during process and formulation development in controlling and minimizing this heterogeneity, which may not affect safety or efficacy and, therefore, may not need...
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| Main Authors: | , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Landes Bioscience
2010
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| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2958571/ https://ncbi.nlm.nih.gov/pubmed/20671426 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4161/mabs.2.5.12897 |
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