Roche CustomBiotech provides rapid and reliable quality control testing kits for residual host cell DNA and residual protein impurities to help you improve your quality control strategy in the manufacture of your product(s).
Residual host cell DNA quantification
In the manufacturing of biologics using expression systems, host cell DNA levels should be low in the final product to meet regulatory guidelines appropriate for the product’s intended use. Manufacturers of biologics use different approaches to show low residual DNA in the purification process and final substance. Pilot experiments showing removal of added host cell DNA, lot-to-lot testing to show purity and reproducibility or an appropriately conducted clearance study for DNA removal are just some examples. The critical consideration regardless of your testing strategy is to use a sensitive residual host cell DNA kit that meets or exceeds the relevant regulatory requirements of your product.
