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Development and Validation of Quantitative Real-Time PCR for the Detection of Residual CHO Host Cell DNA and Optimization of Sample Pretreatment Method in Biopharmaceutical Products

BACKGROUND: The presence of residual DNA carried by biological products in the body may lead to an increased oncogenicity, infectivity, and immunomodulatory risk. Therefore, current agencies including WHO, EU, and the FDA limited the accepted amounts of residual DNA (less than 10 ng or 100 pg/dose)....

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Detalles Bibliográficos
Autores principales:	Zheng, Weifeng, Jiang, Lin, Lei, Qing, Yang, Jun, Gao, Xuefeng, Wang, Wanru, Zhang, Yanli, Kong, Tao, Chen, Qiaoli, Li, Gang
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2019
Materias:	Methodology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6717637/ https://www.ncbi.nlm.nih.gov/pubmed/31496923 http://dx.doi.org/10.1186/s12575-019-0105-1

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