Innovative strategies for residual DNA and viral titre quantitation using dPCR

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Leveraging digital PCR-based assays for the quantitation of residual host cell DNA or viral titres 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 titres, 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 minimising 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.

What you will learn in this webinar:

  • The benefits of using the latest innovative solutions to quantitate host cell DNA or viral titres within a biotherapeutic manufacturing workflow
  • Regulatory compliance with regards to process impurity testing
  • How an integrated workflow solution supports process development and a cGMP environment A Q&A session with the speakers follows the presentations.

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