resDetect

The resDetect™ CHO resDNA Quantitation Kit is designed for the quantitative detection of residual Chinese Hamster Ovary (CHO) DNA in biopharmaceutical products, particularly antibodies. Utilizing real-time quantitative PCR (qPCR), this kit ensures rapid and reliable detection of residual DNA from CHO cells, with a lower limit of quantitation at 3 fg/µL. The entire procedure can typically be completed in less than four hours.

This kit is highly sensitive, with a lower limit of detection at 1 fg/µL, ensuring optimal product safety. It demonstrates high specificity, with no cross-reactivity with unrelated DNA, and consistent performance across a broad range of DNA fragment sizes. The kit's validation follows the ICH Q2(R2) guidelines for analytical procedures, and it is manufactured in an ISO 13485 standard facility, ensuring high quality.

Features

• High sensitivity: LLOQ of 3 fg/µL for detecting residual host cell DNA.
• High specificity: No cross-reactivity with unrelated DNA.
• Validated according to ICH Q2(R2) standards.
• Manufactured in ISO 13485 standard facility.

The kit includes components such as qPCR Master Mix, CHO Primer & Probe Mix, CHO DNA Control, Dilution Buffer, and DNase/RNase-Free Water. It is recommended to use the resDetect™ resDNA Sample Preparation Kit (Magnetic Beads) for optimal DNA recovery.

Applications of this kit are primarily in the quality control and manufacturing processes of biopharmaceutical production. It is intended for research use only and is not for diagnostic purposes.

In testing, the kit demonstrated high sensitivity and specificity, with consistent quantitation across a range of fragment sizes. Standard curves showed PCR efficiency between 90-110%. Spike recovery validation indicated recoveries between 90-100% for CHO DNA samples at various spike levels. Complex sample simulation testing, including samples with high BSA concentrations and varying pH levels, showed spiked recoveries between 98-120%. Additionally, testing during different stages of the CHO antibody purification process yielded spiked recoveries close to 100%.