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The process defines the product: what really matters in biosimilar design and production?
Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2017
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850795/ https://www.ncbi.nlm.nih.gov/pubmed/28903544 http://dx.doi.org/10.1093/rheumatology/kex278 |