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The avermectins compose a class of polycyclic lactones that are used to treat parasitic worms and insect pests. They are naturally occurring compounds generated in a fermentation process by a soil actinomycete Streptomyces avermitilis.
Residual DNA tests
- Contamination by production organism residual DNA
Plasmid DNA is frequently used in gene therapy and high purity plasmids are required. Residual DNA or proteins from the production organism (where plasmid was produced e.g. E. coli) are considered unacceptable contaminant. - Contamination by wild type virus in artificial drug virus
Viral vaccines or vectors are mostly prepared from wild type precursors, which lost their original activity. Artificial virus is less dangerous than wild type and has special characteristics. Wild type virus in a vaccine could have dangerous effect. - Viral contaminants in virus-free material
For the control of biological material it is necessary to check if the material does not contain any hazardous biological substance, such as virus. - Contamination tests on request
development of method and subsequent validation can be included
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.