Consulting and experimental design in close communication between you and your project manager at IMGM include topics like:
The method of detection is established and validated for your specific target and sample sources. Calibration curves ensure accurate absolute quantification of your target nucleic acid by qPCR.
Important aspects to consider are:
The nucleic acid therapeutic is quantified in the main study samples applying the validated qPCR or ddPCR assay and QC criteria from the validation study. Extensive GLP-compliant documentation in submission-ready format facilitates convenient communication with regulatory authorities.