Journal
BIOANALYSIS
Volume 14, Issue 21, Pages -Publisher
Newlands Press Ltd
DOI: 10.4155/bio-2022-0190
Keywords
biodistribution; cell and gene therapy; matrix effect; nucleic acid extraction; qPCR; validation
Ask authors/readers for more resources
This report discusses the importance of using quantitative polymerase chain reaction (qPCR) in bioanalysis and the need to improve its reliability. qPCR can detect target DNA/RNA and provides quantitative and long-term analysis. The authors also provide considerations and validation criteria for bioanalysis using qPCR. The discussion in this report is expected to contribute to the development of validation and sample analysis for pharmaceuticals analyzed using qPCR.
Investigating the biodistribution of cell and gene therapy products may play an important role in evaluating their safety and pharmacology. As quantitative polymerase chain reaction (qPCR) is often used for these analyses, it is essential to improve the reliability of bioanalysis performed using qPCR. In this report, the authors discuss the use of qPCR in nonclinical studies, as it can be used to detect target DNA/RNA and it is quantitative and applicable for long-term analysis. The authors also discuss points to consider during bioanalysis using qPCR and present appropriate validation items and their criteria. The authors anticipate the discussion provided herein to contribute to the development of validation and sample analysis for pharmaceuticals analyzed using qPCR.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available