A Holistic Approach To Bioburden Control In Downstream Processing

By Annie Leahy and Kerry Roche Lentine, MilliporeSigma

Bioburden control is key to successful drug manufacturing, and any lack of control can be disruptive and costly.^{1, 2} Microbial contamination can occur in the upstream or downstream process. The investigation of these bioburden excursions interrupts production schedules and diverts resources from normal operations. Then, corrective and preventative actions are investigated and developed to reduce the likelihood of a repeat occurrence. Understanding the different considerations for bioburden control in various operations and production steps can help define a strategy for successful production.