Leveraging dPCR for residual DNA and viral titer quantitation in advanced therapy manufacture
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Leveraging digital PCR-based assays for the quantitation of residual host cell DNA or viral titers within a biotherapeutic manufacturing workflow offers significant value in ensuring product quality and safety. Digital PCR, or dPCR, is a highly sensitive and precise technique that enables the absolute quantification of nucleic acid targets. In the context of biotherapeutic manufacturing, dPCR provides a robust and accurate method for measuring residual host cell DNA or viral titers, which are critical parameters to assess the purity and potency of biopharmaceutical products. By employing dPCR-based assays, manufacturers can effectively monitor and control the levels of impurities, ensuring compliance with regulatory guidelines and minimizing the risk of adverse effects in patients. Additionally, dPCR's ability to detect low copy numbers and its resistance to PCR inhibitors make it a great analytical tool for biopharma. Overall, leveraging digital PCR-based assays enhances the efficiency, reliability, and quality of biotherapeutic manufacturing workflows, contributing to the development of safe and effective biopharmaceutical products.
- How to enhance the sensitivity and accuracy of host cell DNA or viral titer quantitation within a biotherapeutic manufacturing workflow
- Ensuring regulatory compliance in process impurity testing
- Achieving an integrated workflow to support process development and a CGMP environment
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