Evolving biosimilar guidance creates opportunities to reduce comparative clinical requirements through strong analytical evidence, risk-based justification, structure-function knowledge, and more.
A conversation between Ulrich Köllisch of UMK Consulting and Life Science Connect's Jon O'Connell
Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.
A conversation between Susan Sharfstein at University at Albany and Life Science Connect's Jon O'Connell
Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.
