PDA Letter Article

New Trends, New Challenges for BET

by Jay Bolden, Eli Lilly and Company, and Ned Mozier, PhD, Pfizer


Endotoxin testing for pharmaceutical production processes has seen a number of advances in recent years, among them discovery of recombinant Factor C (rFC) and development of the monocyte activation test (MAT). At the same time, data integrity has become an issue for various test modes.