Residual DNA Testing
Products & Services
Information
Our residual DNA analysis allows compliance with the ICH Q6B Guidelines for a range of GLP/GCP/GCMP compliant methods which are highly accurate, target-specific and sensitive (< 1 copy per µL of template). Real-time qPCR and digital droplet PCR (ddPCR) techniques offer robust quantification to support process validation, monitor batch to batch variation and support of GMP lot release, helping to ensure that products produced from a range of common host cell lines (HEK293, E.coli and CHO cells) meet specification limits for these process impurities. Our assays have been designed and developed in-house and we therefore have the expertise to develop residual DNA assays for any other cell type you may require.
Residual DNA testing methods
The gold standard for residual DNA analysis is based on relative quantification of sample using real-time qPCR, however, digital droplet PCR (ddPCR) provides a number of key advantages over the traditional method. The partitioning nature of ddPCR generates up to 20,000 oil encapsulated droplets where effectively 20,000 individual reactions are performed. The droplet technology offers greater tolerance to PCR inhibitors, improved assay sensitivity and reduced variability, giving a more precise and absolute quantification of the DNA impurity in the biologic therapeutic product without using a standard curve. In addition, the technique can also be used to confirm discoveries made through Next Generation Sequencing (NGS) results.
LINK: https://www.intertek.com/pharmaceutical/biopharmaceuticals/residual-dna-testing/
