Analytical subcloning of a clonal cell line demonstrates cellular heterogeneity that does not impact process consistency or robustness

During development of a cell line intended to support production of an IgG2 monoclonal antibody, a sequence variant caused by a genetic mutation was identified in the bulk drug substance. Gene copy number analysis together with the level of the observed variant in genomic DNA indicated that the mast...

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Detalles Bibliográficos
Autores principales: Scarcelli, John J., Hone, Megan, Beal, Kathryn, Ortega, Alejaida, Figueroa, Bruno, Starkey, Jason A., Anderson, Karin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
TOPICAL PAPER
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099511/
https://www.ncbi.nlm.nih.gov/pubmed/29693321
http://dx.doi.org/10.1002/btpr.2646

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099511/
https://www.ncbi.nlm.nih.gov/pubmed/29693321
http://dx.doi.org/10.1002/btpr.2646

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