Ancillary Material Considerations for a Seamless Transition into GMP Manufacturing
Points for discussion
- When should you start to consider switching to GMP-grade ancillary materials?
- Why use preclinical grade reagents for preclinical research instead of RUO reagents?
- Which quality attributes are relevant for preclinical research? How to qualify ancillary materials and assess their quality and economic risks?
Tess Kitchener, Vice President, BaseCamp Business Development, Elevatebio
Bernd Leistler, Vice President Production, Sartorius CellGenix
Isaac Zentner, Associate Director, Process Development, Carisma Therapeutics
Stefano Baila, Managing Director, Eurofins
Lili Belcastro, Senior Principal Scientist, Cell and Gene Therapy Raw Materials, Bristol Myers Squibb