Contamination Control Strategies (CCS) In Low Bioburden Biologic Drug Substance Manufacturing

The revised Annex 1 introduces a broader, more integrated approach to contamination control through the concept of a Contamination Control Strategy (CCS). Traditionally, control strategies focused on parametric controls tied to critical process parameters like temperature and pH. Now, CCS demands a more holistic view—one that connects microbiological, particulate, and endotoxin risks across the entire manufacturing environment. This ebook explores how manufacturers can apply CCS principles in non-sterile, low-bioburden biologic drug substance sites and adapt them for legacy facilities. It outlines the CCS development process, quality risk management, documentation structure, and the role of CCS in driving continuous improvement.

For facilities navigating this shift, discover how to tailor your controls.