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Regulatory-Compliant Validation of a Highly Sensitive qPCR for Biodistribution Assessment of Hemophilia A Patient Cells

The investigation of the biodistribution profile of a cell-based medicinal product is a pivotal prerequisite to allow a factual benefit-risk assessment within the non-clinical to clinical translation in product development. Here, a qPCR-based method to determine the amount of human DNA in mouse DNA...

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Detalles Bibliográficos
Autores principales: Bittorf, Patrick, Bergmann, Thorsten, Merlin, Simone, Olgasi, Cristina, Pullig, Oliver, Sanzenbacher, Ralf, Zierau, Martin, Walles, Heike, Follenzi, Antonia, Braspenning, Joris
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Gene & Cell Therapy 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327859/
https://www.ncbi.nlm.nih.gov/pubmed/32637449
http://dx.doi.org/10.1016/j.omtm.2020.05.029