By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.
Stem cell assays allow scientists to assess the self-renewal capacity, proliferation rate, differentiation potential, and other characteristics of stem cells. By understanding how stem cells respond to different conditions, scientists can optimize protocols for therapeutic use. Let's look at six emerging trends in using stem cell assays.