Donald Powers

Cell and gene therapy manufacturers are increasingly constrained by particulate  contamination introduced through single use systems, without the safety net of terminal  sterile filtration. At the same time, regulatory expectations continue to reflect standards written for large molecule drug products, creating a disconnect between what is  technically achievable and what is formally required. This workshop focuses on how manufacturers are interpreting guidance, engaging regulators, and redefining risk in a way that prioritises patient outcomes while maintaining quality and compliance.

This workshop will discuss:

• Assessing the real clinical risk of visible and subvisible particles in cell and gene therapy products
• Interpreting legacy particulate standards and test methods that were not designed for cell and gene therapies
• Balancing regulatory expectations with manufacturing limitations and patient access pressures
• Defining what clean enough means for single use systems without driving unsustainable cost or waste