Biotherapeutics Workshop

The evaluation of biopharmaceuticals for the presence of host cellular contaminants is a critical aspect in assuring quality and safety of these products. Consequently, host cell DNA should be detected using a suitably sensitive analytical technique and quantitative data is needed to ensure a high-quality and safe therapeutic product. To maximize process safety and precision, the complete workflow should be fully automated.QIAGEN has developed an automated process to extract host cellular DNA from in-process samples in a variety of sample matrices with consistently high recovery, reproducibility, and robustness. No pretreatment of samples or prior adjustment of parameters, such as pH or protein concentration, is required. Using this process, we can detect as little as 1 pg of DNA by quantitative PCR. Recovery of spiked genomic DNA in various process buffers has been determined to be 80–100%. All essential parameters, such as LOD, LOQ, linear range, and precision, have been determined. The linear range of detection is from 1 pg to 2 µg gDNA, and is valid for the complete range of process samples — from fermenter harvests, process purification samples, and final product formulations, as obtained in clearance studies.

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