Transitioning A Process And Qualifying GMP Materials

This opening segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” features panelists Tiffany Rau, Ph.D., an adjunct professor at University College Cork, co-founder of BioPharam Technical Consulting, and founder of Rau Consulting; Mary Rodley, an independent consultant at Medius Consulting; and Wei Lu, Ph.D., a senior staff engineer in downstream process development at Takeda. They share their thoughts on when preparation for clinical manufacturing should begin, especially in terms of qualifying compendial and GMP-grade materials.