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Impurities quality control testing

Select the right kit for testing impurities

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). 

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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.

 

Residual DNA E. coli kit and CHO kit

 

Roche CustomBiotech detection solutions for residual host cell DNA are based on real-time quantitative PCR (qPCR) that provides highly sensitive quantitation of DNA levels from E. coli or CHO expression systems. Robust and easy to use, the kits can be employed at each step in the purification process and in drug substance samples to confirm purity within hours. Developed to meet WHO requirements, the kits offer exceptional sensitivity.

  • Highly sensitive quantification of host cell DNA that meets WHO requirements
  • Suitable for use across a broad range of sample types and at various stages of your process
  • Optimized sample preparation protocol for high DNA recovery
  • All-inclusive reagents kit
pipette

Residual protein presence and activity quantification

 

These kits complement the Roche CustomBiotech Liberase enzyme blend and Recombinant Trypsin products suitable for use in process development, in-process control, and final quality control. The kits are  highly sensitive immuno assay with tailor-made polyclonal antibodies against the components of the Liberase blend (Collagenase I/II and Thermolysin) and Recombinant Trypsin, respectively, making testing for residual protein components fast and reliable.  

The Collagenase Activity test kit provides quantifies the activity of collagenase I, collagenase II, and the Liberase enzyme blends.  Based on the enzymatic hydrolysis of FALGPA substrate, the kit is designed to perform testing in 96-well flat-bottom plates with dynamic absorbance measurements on a plate reader.

Regulatory disclaimers are listed on the respective product pages.

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