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 validating new materials, ensuring regulatory compliance, performing risk assessments, and evaluating facility fit. Unexpected challenges in any aspect of this transition can be costly and delay a product’s time to enter the clinic.

Join Bioprocess Online’s Tyler Menichiello for an interactive panel discussion on phase-appropriate CMC decisions and material selection for GMP readiness. This conversation will feature Wei Lu, Ph.D., a senior staff bioprocess engineer at Takeda; Tiffany Rau, Ph.D., owner and principal consultant at Bio Pharma Technical Consulting; and Mary Rodley, an independent consultant with Medius Consulting, LLC. These experts will focus on the challenge of sourcing and implementing GMP-grade materials and equipment in a process for the first time.

Whether you’re in the throes of transitioning into clinical manufacturing or are preparing to do so, this event will identify the key considerations and choices that matter the most.