Ensuring Product Quality, Consistency and Patient Supply over Time for a Large-Volume Biologic: Experience with Remicade(®)

Biologics are produced from living organisms in complex, multi-stage manufacturing processes and contain inherent variability, which must be understood and controlled during manufacturing to avoid unexpected changes in key quality attributes that may contribute to clinically meaningful differences....

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Detalles Bibliográficos
Autores principales: Melsheimer, Richard, Calmann, Melissa, DeRitis, Albert, Philip, Vinod, Van Gog, Frank, Doolittle, Lawrence, Goyal, Kavitha, Neblock, Donald
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Current Opinion
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182491/
https://www.ncbi.nlm.nih.gov/pubmed/30143982
http://dx.doi.org/10.1007/s40259-018-0300-7

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182491/
https://www.ncbi.nlm.nih.gov/pubmed/30143982
http://dx.doi.org/10.1007/s40259-018-0300-7

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