Changes in Manufacturing Processes of Biologic Therapies Can Alter the Immunogenicity Profile of the Product

Manufacturing process changes may alter the characteristics of a protein therapeutic. In 2009, somatropin (version 1.0), a recombinant human growth hormone therapeutic, underwent a manufacturing update (version 1.1). The immunogenicity of somatropin version 1.1 as a daily subcutaneous injection was...

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Detalles Bibliográficos
Autores principales: Vanderlaan, Martin, Maniatis, Aristides, Olney, Robert, Rahmaoui, Abdelkader, Yau, Linda, Quarmby, Valerie, Azzolino, Craig, Woods, Cynthia, Moawad, Dalia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158213/
https://www.ncbi.nlm.nih.gov/pubmed/31628764
http://dx.doi.org/10.1002/cpt.1694

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158213/
https://www.ncbi.nlm.nih.gov/pubmed/31628764
http://dx.doi.org/10.1002/cpt.1694

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