Knowing the right time to introduce cGMP raw materials when scaling up mAbs manufacturing avoids production process redevelopment, delays and increased costs. Using cGMP grade reagents earlier makes for a seamless transition while maintaining quality and viability. Learn key considerations for a seamless scale up process in our GMP fact sheet.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, raising oversight questions for pharma teams.