Pharmacokinetic and Hematological Monitoring are crucial to preclinical studies in cell and gene therapy. However, mouse models have strict constraints on blood sampling volume and frequency. Increasing bleeding frequency and reducing sampling volume at each time point allow more time points of data to be collected from mice. While ddPCR is powerful technology in collecting pharmacokinetic data, it currently lacks proper protocols to ensure regulatory compliance. In this poster, we discuss a GLP-compliant validation of our ddPCR method, which is highly sensitive, selective, specific, robust, and stable. We developed two combined novel protocols that produce a pharmacokinetic and hematological profile using only ~25-30 µL of mouse blood that minimizes adverse physiological effects. The protocols use 20 µL of mouse blood to extract 200 to 800 ng of genomic DNA for multiple ddPCR reactions and 2.5 to 5 µL of mouse blood to produce detailed hematological data.
Learning Objectives:
Upon completion, participant will be able to use our novel methods to monitor daily hematological profile and targeting gene copies (ddPCR) by using only 25-30uL mouse blood in preclinical study.
Upon completion, participant will be able to learn how we validate droplet digital PCR method in a GLP-compliant mode.
Upon completion, participant will be able to learn how we can use 2.5-5uL mouse blood to produce hematological profiles with 21 parameters.
