Pre-Conference Day

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

Moving from research to GMP and then to commercial materials is a common source of delay and regulatory risk when this strategy is not planned early. Many teams discover too late that materials used in early development cannot scale, or that supplier controls are not aligned with late-stage expectations. This workshop focuses on how to plan material grade transitions proactively so your scale up journey can progress without disruptive requalification or friction in your process changes.

This workshop will discuss:

• Identifying materials that will not scale beyond research or early GMP use
• Assessing supplier readiness and grade roadmaps before phase three
• Aligning material grade strategy with development phase to reduce requalification work
• Discussing the transition from late-stage to commercial and long-term life-cycle monitoring via the CPV process and improvements to raw materials