GLP-certified quantification of nucleic acid therapeutics
Tumorigenesis, chromosomal instability and vertical transmissions in germline cells are potential risks of gene therapy or DNA vaccine approaches. To address these issues, regulatory agencies worldwide require pre-clinical ex vivo biodistribution studies to evaluate the safety and toxicity of nucleic acid therapeutics.
At IMGM, we design GLP-certified qPCR biodistribution studies investigating
- Persistence of the nucleic acid therapeutic in target tissues
- Dissemination into non-target tissues
- Expression in germ lines
by relative or absolute target quantification.
Typically, samples are collected from multiple organs and body fluids after several time-points post administration of the compound. As experts in qPCR analyses, we understand that RNA or DNA extraction from these samples is a very crucial step in the process, since they will be used for highly sensitive molecular testings. Therefore, the risk of contamination has to be minimized by working under the most stringent conditions. Real-Time qPCR data is generated using e.g. TaqMan or SYBR Green chemistry on the ViiA7 instrument (Life Technologies) or digital PCR on the QX200 Droplet Digital PCR System (Bio-Rad). The entire study may be carried out in compliance with GLP.
Looking for In Vivo?
The in vivo part of a preclinical biodistribution study at IMGM can be performed by our strategic partner LPT in Hamburg, Germany, in various model organisms.
Contents of a biodistribution study at IMGM
Our expert team has long-standing experience in complex qPCR assay design and validation, resulting in high-quality data that can be used for determination of:
- Limit of detection and quantification
- Sensitivity and selectivity
- Precision and accuracy
- Recovery rates and stability
All experiments are performed using internal controls. The main study is then conducted with the validated qPCR biodistribution assay, which can also be used in later phase clinical studies. Results are reported in an easy to understand and very detailed manner, assuring comprehensive GLP-documents.
IMGM's GLP-certified biodistribution services include:
- Experiment design according to your requirements
- Strict definition and observance of timelines
- Detailed study plan
- Professional assay design and validation
- Expert knowledge in isolation of high quality nucleic acids
- Comprehensive data analysis
- Extensive GLP-compliant reporting
- Archiving of study samples and reference items (Biobanking)
See a detailed workflow description here.
Go for enhanced analytical power!
Entrust IMGM with your next Biodistribution Study.