Strategies & Designs for Overcoming Product Instability in Quality Control for Streamlined Regulatory Approval

Time: 8:30 am
day: Workshop B - Quality Control

Details:

Ensuring the stability of cell therapy products is essential for their safety, efficacy, and regulatory approval. However, detecting and addressing product instability poses significant challenges. This workshop will delve into innovative strategies and methodologies to navigate the complexities of product instability in cell therapy stability studies. From determining critical stability parameters to leveraging advanced analytics, gain insights into optimizing stability assessment protocols and ensuring long-term efficacy.

Join us to:

  • Gain insights into critical stability parameters essential for assessing cell therapy products. Learn to establish robust stability study protocols tailored to product characteristics.
  • Explore novel methodologies for detecting and addressing product instability. Discuss alternative study designs and innovative stress-inducing techniques.
  • Acquire actionable strategies from industry experts. Engage in interactive discussions to exchange ideas and learn from real-world case studies.

Speakers: