Residual DNA testing, or host cell DNA analysis, is the examination of products for traces of DNA that have been unintentionally left on a product during manufacturing of biological products such as biosimiliars or immunotherapeutic products. For customer health safety, it is imperative that manufacturers of biological or biotechnical products ensure no contamination of their products with residual DNA has occurred.
Host cell DNA can be present in products such as food, animal feed, and biopharmaceuticals. Most manufacturing and production processes include procedures to purify and remove any DNA traces, though it is still necessary to verify the amount of residual DNA in products.
Removing host cell DNA is a critical step in purifying biopharmaceutical products. Strict guidelines established by the World Health Organization, the FDA, and the European Pharmacopoeia exist to ensure product and drug safety.
Detection and quantification of host cell DNA is generally done through three sensitive test methods:
- Threshold Assay -for nonspecific quantification
- Hybridization Assay – detects specific DNA
- qPCR Assay – detects specific DNA, targeting a specific sequence for amplification
Need help finding a lab for residual DNA testing?
See how Contract Laboratory has helped other organizations find genetics laboratories to perform their necessaryDNA testing:
- USA FDA GMP Bioanalytical Laboratory needed for testing by Hybridization
- BcGMP Pharmaceutical Bioanalytical laboratory needed for tesing via slot blot method to determine DNA content in a biopharmaceutical drug substance
- Genetics laboratory needed for testing residual DNA in recombinant protein samples
- Genetics laboratory needed for real-time PCR Residual DNA testing estimation in our recombinant therapeutic proteins.
- USP Release testing/confirmation (USP): Residual DNA by qPCR, Impurity determination by RP HPLC, Atomic adsorption determination of heavy metals (Nickel)
- plus many more genetics test requests
To learn more about the types of genomics research and testing projects Contract Laboratory has helped facilitate, view genetics testing projects.
To see how we can help with your genetics research and analysis, call us at 1-855-377-6821 or submit a request!