Strategic Assay Development: When to Invest, Implement, & Innovate Advanced Analytical Methods in Cell & Gene Therapy
Time: 9:00 am
day: Pre-Conference Assay Development Track A - AM
Details:
- This workshop explores the integration of advanced analytical methods, such as NGS, ddPCR, and mass spectometry, into assay development for cell and gene therapies. Gain insights into balancing cost, regulatory requirements, and outsourcing to optimise analytical strategies for innovative therapies.
- Timing & Cost-Effectiveness: Identify when to integrate advanced assays like NGS, ddPCR, or Raman spectroscopy into assay development pipelines while balancing cost and practicality
- Regulatory Readiness: Discuss how regulatory requirements influence assay design and when to elevate exploratory methods like mass spectrometry, capillary electrophoresis, or flow cytometry to standard release criteria
- Access & Feasibility: Explore the role of CROs in assay development and how to navigate outsourcing challenges for advanced analytical methods
