Regulatory authorities such as the WHO, FDA, and European Pharmacopoeia recommend that residual host cell DNA in biopharmaceutical products must not exceed 10 ng per dose. Even after extensive purification, trace amounts of DNA from CHO, HEK-293, and E. coli cells may remain in the final product, posing potential safety and compliance challenges. Reliable residual DNA analysis is therefore essential to meet regulatory requirements and ensure product quality.

Our solution: The MiQuant^® dPCR assay enables direct analysis without DNA extraction, absolute quantification, and reliable detection of even highly degraded DNA – ensuring maximum safety and efficiency in your quality control.

Our optimized MiQuant® Residual DNA HEK-293 - dPCR Kit is now compatible with QIAcuity^®, ddPCR™, QuantStudio™ Absolute Q™, and other commercial dPCR systems, enabling fast and reliable residual DNA quantification.

Your key benefits at a glance:

✔ Fast & easy analysis – No DNA extraction required
✔ Absolute quantification – No standard curve necessary
✔ Regulatory compliance – Meets WHO, FDA, and EP guidelines

✔ Validated on QIAcuity® 26k Nanoplate – Validation report available on request
✔ Maximum stability – Lyophilized reagents for easy handling
✔ High sensitivity – Reliable detection of even the lowest amounts of residual DNA

Ensure the quality of your products – simply and precisely!