Naveenganesh Muralidharan, nmural@agcbio.com, is senior manager, Manufacturing Science and Technology (MSAT), at AGC Biologics.
Investigating Bioreactor Contamination, Modeling Contaminant Introduction, and Ensuring Bioburden Test Reliability
This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.