Journal of the American Pharmacists Association
Fecha de publicación: 5 October 2019
DOI: https://doi.org/10.1016/j.xphs.2019.09.023
Autores: Tapan K. Das, Linda O. Narhi, Alavattam Sreedhara, Tim Menzen, Christoph Grapentin, Danny K. Chou, Valentyn Antochshuk, Vasco Filipe.
Background: The success of biotherapeutic development heavily relies on establishing robust production platforms. During the manufacturing process, the protein is exposed to multiple stress conditions that can result in physical and chemical modifications. The modified proteins may raise safety and quality concerns depending on the nature of the modification.
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