Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity

PURPOSE: Following two cases of neutralizing antibodies to epoetin alfa in an investigational clinical study, a small number of individual syringes of two drug product batches were found to contain unusually high levels of aggregation at the end of the clinical trial. METHODS: We undertook an extens...

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Detalles Bibliográficos
Autores principales: Seidl, Andreas, Hainzl, Otmar, Richter, Marleen, Fischer, Robert, Böhm, Stephan, Deutel, Britta, Hartinger, Martin, Windisch, Jörg, Casadevall, Nicole, London, Gerard Michel, Macdougall, Iain
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2011
Materias:
Research Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3349029/
https://www.ncbi.nlm.nih.gov/pubmed/22094831
http://dx.doi.org/10.1007/s11095-011-0621-4

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