Changes in residual DNA detection standards of biological products
The United States Pharmacopoeia introduces three kinds of commonly used technologies in General Chapter. New edition (USP38-NF33) in 2015 added a new chapter (General Chapter) to further standardize the method of residual DNA detection and the standard material. Unlike chapters 1000 or more, chapters within the USP code 1000 provide inspection techniques, system suitability standards and standard materials in detail. In the new version of USP, qPCR will be the only recommended method for host residual DNA in biological products. qPCR has the advantages of high sequence specificity, high sensitivity and good reproducibility. It can provide a reliable means for the biopharmaceutical industry in the process research and the quality control of finished products.
Why should the residual DNA be detected?
Residual DNA may have an infectious or tumorigenic risk. In addition, the genomic DNA of microbial origin is rich in CpG and non methylated sequences, which increases the immunogenic risk of recombinant protein drugs in vivo. In the biological product, the host residual DNA is not only the impurity in the production, but also has the certain security hidden danger.
Various residual nucleic acid detection techniques
Hybridization-based: The residual DNA in the sample can be semi quantitatively determined by visual inspection.
DNA-Binding protein-based: This method uses DNA binding proteins and DNA antibodies.
Quantitation PCR-based: qPCR method has been applied to some fields of biological pharmacy because of its fast, high throughput characteristics.
Standard and technology for residual DNA quantification in biological products
Yeast & Escherichia coli expressed biological products are limited in no more than 10 ng/agents. CHO & Vero cells expressed EPO, rabies vaccine and hepatitis B vaccine are no more than 100 or 10 pg/agent
Technical performance of kit in standard substance library
In addition to the use of conventional methods of study and study the stability, Creative Biogene also carried out DNA fragmentation, species specificity, versatility of different instruments, anti-protein interference, etc. to launch residual E.coli DNA, residual Yeast DNA and residual Vero DNA detection kit, providing support for the development of bio pharmaceutical industry.
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Website: http://www.creative-biogene.com
