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Characterization of phenotypic and genotypic diversity in subclones derived from a clonal cell line
Regulatory guidelines require the sponsors to provide assurance of clonality of the production cell line, and when such evidence is not available, additional studies are typically required to further ensure consistent long‐term manufacturing of the product. One potential approach to provide such ass...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099272/ https://www.ncbi.nlm.nih.gov/pubmed/29882350 http://dx.doi.org/10.1002/btpr.2666 |