Скачать или смотреть Residual DNA Testing Explained: qPCR Quantification and Biopharmaceutical Safety

Residual DNA testing is a critical analytical requirement in modern biopharmaceutical development, ensuring the safety and quality of biologic drugs produced using host cell expression systems.
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During biologics manufacturing, residual host cell DNA from systems such as CHO cells or E. coli may remain in the final drug product. If not properly controlled, this genetic residue can pose potential safety risks, including immunogenicity, viral contamination, or oncogenic effects. Regulatory agencies such as the FDA have established strict limits—typically no more than 10 ng of residual DNA per dose—requiring highly sensitive and reliable analytical methods.
In this video, we explore how high-precision analytical technologies make invisible biological signals measurable, covering:
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How microscopic molecular signals regulate cellular behavior and disease progression
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Why residual host cell DNA is a critical safety concern in biopharmaceuticals
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How qPCR enables ultra-sensitive detection and accurate quantification of trace DNA
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Why qPCR outperforms legacy methods in sensitivity, specificity, and turnaround time
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The role of precision analytics in meeting global regulatory expectations
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Residual DNA analysis is a foundational component of biopharmaceutical quality control, process development, and regulatory compliance. As therapeutic modalities become more complex, access to robust analytical platforms and expertise is increasingly essential for both research and manufacturing.
Understanding and controlling residual DNA is not just a regulatory checkbox—it is a core part of ensuring patient safety and advancing modern medicine.