Monitoring process-related impurities in biologics–host cell protein analysis

During biologics development, manufacturers must demonstrate clearance of host cell impurities and contaminants to ensure drug purity, manufacturing process consistency, and patient safety. Host cell proteins (HCPs) are a major class of process-related impurities and require monitoring and documenta...

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Detalles Bibliográficos
Autores principales: Pilely, Katrine, Johansen, Martin Rask, Lund, Rikke Raaen, Kofoed, Thomas, Jørgensen, Thomas Kjærsgaard, Skriver, Lars, Mørtz, Ejvind
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Feature Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483941/
https://www.ncbi.nlm.nih.gov/pubmed/34595561
http://dx.doi.org/10.1007/s00216-021-03648-2

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483941/
https://www.ncbi.nlm.nih.gov/pubmed/34595561
http://dx.doi.org/10.1007/s00216-021-03648-2

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