Making The Jump To GMP: Material Decisions For Clinical Manufacturing

Transitioning development processes into GMP manufacturing can come with a fair share of growing pains. Development teams need to contend with things like sourcing and qualifying new materials, ensuring regulatory compliance, and performing risk assessments. Unexpected challenges in any aspect of this transition can be costly and delay a product’s time to enter the clinic.

This interactive panel discussion focused on phase-appropriate CMC decisions and material selection for GMP readiness. The panel included Wei Lu, Ph.D., a senior staff bioprocess engineer at Takeda; Tiffany Rau, Ph.D., Co-Founder of BioPharma Technical Consulting, and Founder of Rau Consulting; and Mary Rodley, an independent consultant with Medius Consulting, LLC. Thermo Fisher Scientific representative and expert Mike Brewer also joined the panel for a special audience Q&A session.

These panelists focused on the challenges of sourcing and implementing GMP-grade materials in a process for the first time and spoke about the common pain points teams encounter when transitioning a process from development to clinical-stage manufacturing.