Join us for the ISCT MMST Educational Webinar on "Visible Particulates in Cell and Gene Therapy: Challenges and Perspectives in Risk Assessment," scheduled for November 13, 2025. This session, sponsored by Gateway Analytical, seeks to explore the unique challenges posed by visible particulates in low-unit cell and gene therapy (CGT) batches. As regulatory concerns mount and traditional standards fall short, our expert panel will share insights from various stakeholders, including manufacturers, service providers, and regulatory consultants. 

Discover the operational impacts of lot rejection, learn about best practices for managing particulate risk, and delve into regulatory expectations. This webinar will focus on practical strategies and best practices while providing actionable approaches for managing visible particulates. Participants will gain valuable insights into navigating these challenges in their work, ultimately leading to improved outcomes in cell and gene therapy manufacturing. Join us to engage with industry leaders, identify knowledge gaps, and contribute to a dialogue that prioritizes patient safety while addressing the complexities of CGT manufacturing. Don't miss this opportunity to be part of an essential conversation shaping the future of cell and gene therapy quality standards!

Learning objectives:

1. Understand the misalignment between traditional particulate standards and the realities of cell and gene therapies (CGT).

2. Discover how manufacturers, service providers, and regulators tackle particulate challenges in their respective roles.

3. Gain practical insights from service providers experienced in managing particulates in real-world settings.

4. Explore regulatory precedents that allow for tolerance of particulate risks in other high-stakes contexts. 5. Identify significant knowledge gaps and recognize the necessity for structured, CGT-specific approaches and solutions.