A general evidence-based sequence variant control limit for recombinant therapeutic protein development

Sequence variants (SVs) resulting from unintended amino acid substitutions in recombinant therapeutic proteins have increasingly gained attention from both regulatory agencies and the biopharmaceutical industry given their potential impact on efficacy and safety. With well-optimized production syste...

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Detalles Bibliográficos
Autores principales: Zhang, Aming, Chen, Zhengwei, Li, Meinuo, Qiu, Haibo, Lawrence, Shawn, Bak, Hanne, Li, Ning
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2020
Materias:
Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531532/
https://www.ncbi.nlm.nih.gov/pubmed/32744138
http://dx.doi.org/10.1080/19420862.2020.1791399

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531532/
https://www.ncbi.nlm.nih.gov/pubmed/32744138
http://dx.doi.org/10.1080/19420862.2020.1791399

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