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
Abstract: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 tissues of the host organism can affect amplification efficiency and amplicon detection to varying degrees, and ignoring these matrix effects can easily cause a significant underestimation of the true number of target … Show more
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