Biodistribution (BD) studies are critical components when assessing the preclinical safety evaluation of cell and gene therapy molecules. BD analysis is generally conducted at the molecular level using a methodology that provides high sensitivity.
Nucleic acid DNA/RNA – Biodistribution studies
Cell and gene therapy are new branches of pharmaceutical research, which use new types of drugs and strategies. New types of analytical methods are obviously needed. These methods are mostly based on DNA or RNA analysis, which is not surprising, as nucleic acid such as viral vectors, naked DNA (like plasmid, oligonucleotide) or RNA, as active agens is typically used for methods of gene therapy.
If you want to measure distribution or degradation of your DNA drug, molecular biology methods are the first choice. These methods are based on PCR and are very sensitive and selective. Only few copies of DNA in mixture of host organism DNA should be detected. And looking for a needle in a haystack is exactly the work for GENERI BIOTECH, who is regarded an expert in DNA diagnostic and analysis for more than 20 years.
GENERI BIOTECH specializes in analysis of nucleic acids, especially those needed in biodistribution and safety studies for gene therapy drugs. We have experiences with different types of tissues/matrices analysis, where we take into account special needs of each matrix type – isolation, inhibitors, etc.
Method development and validation, that is tailored to fit our customers’ needs and meets requirements of the authorities, is a matter of course to us. Sample analysis, handling and reporting is an integral part of a study, as well as consulting a study plan or auditing by the customer.
Typical target material
- Plasmid DNA
- Viral DNA
- Target genomic DNA
- Ration between host and applied DNA
- Quality control – DNA contaminants