A Risk-Based Approach To Design, Operations, And Grades In Low Bioburden Drug Substance (DS) Manufacturing – Industry Interpretation Of Annex 1

As regulatory expectations evolve, manufacturers of low-bioburden biological drug substances face increasing uncertainty around how Annex 1 guidance—originally intended for sterile products—applies to their operations. While Annex 2 remains the primary regulatory framework for these facilities, recent revisions to Annex 1 suggest broader applicability, prompting questions across the industry. This ebook offers much-needed clarity, advocating for a scientific, risk-based approach rather than a rigid application of sterile manufacturing requirements. It explores key areas such as cleanroom classifications, barrier technologies, and contamination control strategies, and emphasizes the importance of aligning controls with actual risk levels.

Explore more to better understand how to navigate Annex 1’s implications for low bioburden DS manufacturing.