Understanding quantitative polymerase chain reaction bioanalysis issues before validation planning: Japan Bioanalysis Forum discussion group.

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.

Preclinical study of a DNA vaccine targeting SARS-CoV-2.

To fight against the worldwide COVID-19 pandemic, the development of an effective and safe vaccine against SARS-CoV-2 is required. As potential pandemic vaccines, DNA/RNA vaccines, viral vector vaccines and protein-based vaccines have been rapidly developed to prevent pandemic spread worldwide. In this study, we designed plasmid DNA vaccine targeting the SARS-CoV-2 Spike glycoprotein (S protein) as pandemic vaccine, and the humoral, cellular, and functional immune responses were characterized to support proceeding to initial human clinical trials.

Evaluation of hepatocyte growth factor plasmid therapeutic effect by 99mTc-hexakis-2-methyoxy-isobutylisonitrile blood flow scintigraphy in a rat model of hind limb ischemia.

Objective: This study was conducted in an attempt to use blood flow scintigraphy with 99mTc-hexakis-2-methyoxy-isobutylisonitrile (99mTc-MIBI) for the evaluation of the angiogenic effect of hepatocyte growth factor (HGF) plasmid in a rat model of hind limb ischemia.

Materials And Methods: The femoral artery of the left hind limb of each rat was ligated to create a model of hind limb ischemia. Three weeks later, HGF plasmid (1.