Drug Regulatory-Compliant Validation of a qPCR Assay for Bioanalysis Studies of a Cell Therapy Product with a Special Focus on Matrix Interferences in a Wide Range of Organ Tissues

Drug Regulatory-Compliant Validation of a qPCR Assay for Bioanalysis Studies of a Cell Therapy Product with a Special Focus on Matrix Interferences in a Wide Range of Organ Tissues

Quantitative polymerase chain reaction (qPCR) has emerged as an important bioanalytical method for assessing the pharmacokinetics of human-cell-based medicinal products after xenotransplantation into immunodeficient mice. A particular challenge in bioanalytical qPCR studies is that the different tis...

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Bibliographic Details
Main Authors: Hannes M. Schröder, Elke Niebergall-Roth, Alexandra Norrick, Jasmina Esterlechner, Christoph Ganss, Markus H. Frank, Mark A. Kluth
Format: Article
Language:English
Published: MDPI AG 2023-07-01
Series:Cells
Subjects:
ABCB5
biodistribution
cell therapy
HSSATA17 sequence
mesenchymal stromal cells
quantitative polymerase chain reaction
Online Access:https://www.mdpi.com/2073-4409/12/13/1788

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