Residual DNA Testing
If one speaks about genetically modified organisms (GMOs), genetically modified crop plants are usually the topic of focus. However, GMOs are also applied in the areas of biological and medical research as well as in the pharmaceutical and chemical industries. Contamination from genetically modified microorganisms (GMMOs) can be detected in these products with the help of sensitive and specific DNA analysis.
Food and Feed
Various substances in the food and feed industries are produced using GMMOs. From simple amino acids as additives or dietary supplements and aromas to enzymes used as processing aids, there are a wide range of substances which are acquired by way of fermentation processes. Vitamins such as vitamin B2 (riboflavin), vitamin H (biotin), vitamin C (ascorbic acid) and vitamin B12 are today more and more frequently being produced with the help of biotechnological processes. Residual DNA of the used GMMO can be present in the final product and constitutes contamination. Tests for the presence of GMMOs and their DNA are, therefore, an important component with respect to the approval of new products and ongoing quality control.
A growing number of pharmaceutical products are produced in host organisms such as bacteria (E. coli), yeasts (P. pastoris) or eukaryotic cell lines (CHO, HEK294, PER.C6®). These so-called biopharmaceuticals can be contaminated with residual DNA from the host cell culture. In their guidelines, the WHO (World Health Organization) as well as the responsible agencies in the USA (Food and Drug Administration, FDA) and in Europe (European Medicines Agency, EMA) refer to the potential risks of residual DNA from the host organism in biopharmaceuticals. All authorities regard the possibility of a gene transfer of residual DNA fragments from a biopharmaceutical into the genome of a patient to be of highest risk. In this case, the risk of an unwanted effect not only depends on the potential danger of the DNA sequence itself, but also in a random insertion in the genome of the patient. Continuous cell lines, which potentially contain tumourigenic properties, are given the highest risk rating by the agencies, while target lines with defined non tumourigenic changes are viewed as being less of a risk.
Legal Bases and Guidelines
- Regulation (EC) No 1331/2008
- Regulation (EC) No 1829/2003 (genetically modified food and feed)
- Regulation (EC) No 1831/2003 (additives for use in animal nutrition)
Other Interesting Pages
Method Development and Validation
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