Alison Burkart

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