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Improving Biopharma QC workflow: Insights from industrial experts: Program
| Talk Title | Speaker | Abstract | Duration |
|---|---|---|---|
| Genetic analysis tools for quality control of mRNA vaccines | Dr. Stephen Jackson | Sequence confirmation is a critical activity during mRNA therapeutic and vaccine manufacturing, both during plasmid production and mRNA identity testing. Sanger sequencing provides the accuracy, workflow simplicity, scalability, and reproducibility to help ensure testing consistency and final product safety. In this webinar, we will discuss methods for sequence confirmation and mRNA identity testing in vaccine quality control (QC). | 20 mins |
| Digital PCR: modern precise solution to quality control in cell and gene therapy development | Dr. Karolina Setyowati | The field of personalized medicine is experiencing significant advancements with the rise of cell and gene therapy. While Quantitative PCR (qPCR) has been the go-to technique for measuring nucleic acids for many years, it has its limitations. One major drawback is that each qPCR run requires standard curves, leading to biases and inconsistencies and hindering absolute quantification. Recently, digital PCR has emerged as a strong contender to overcome these challenges, offering improved sensitivity and simplified analysis. It provides an exceptional level of precision and consistency in quality control for cell and gene therapies. In this session, we will delve into the technology behind digital PCR and highlight its superiority as a method for precise and consistent quality control in the context of cell and gene therapies. | 20 mins |
| Enhancing safety and quality assurance with rapid NAT-based mycoplasma detection | Tom Tung | In therapeutic development and manufacturing, undetected mycoplasma contamination can negatively impact both product quality and patient safety. Therefore, cGMP manufacturers develop stringent risk mitigation plans for early detection of mycoplasmas to avoid costly manufacturing delays or remediation activities. During this presentation, Tom will discuss the principles and performance of new rapid NAT-based methods of mycoplasma testing. | 20 mins |
For Research Use Only. Not for use on diagnostic procedures.
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