How Process Closure Can Reduce Risk

Featured in a recent edition of the BioProcessing Journal, within this article our ATMP and Biologics Practice Lead, Jeff Odum, CPIP, delves into the intricate world of closed systems in biomanufacturing. Introduced in the draft issue of ICH Q7 in 2000, closed systems have become a cornerstone in risk mitigation for biopharmaceutical manufacturing, aligning with cGMP standards.

The global regulatory landscape recognizes three definitions of closed systems, emphasizing product protection by preventing exposure to the manufacturing environment. The primary goal is to ensure patient safety by focusing on safety, efficacy, and quality.

Jeff emphasizes the importance of understanding potential contamination sources in bioprocessing environments, ranging from raw materials to personnel and equipment. He shares the concept of closure boundaries, defining the primary and secondary system barriers to safeguard products during manufacturing.

Stressing the need to treat each biomanufacturing unit operation as a unique closed system, he shares how the closed process prioritizes open aseptic operations and includes a Closure Analysis Risk Assessment (CLARA) to demonstrate risk mitigation for each component.

Using a Genesis AEC project as a case study, Jeff illustrates the impact of process closure on biomanufacturing design. By transitioning from an open to a closed system, the biotech manufacturer achieved significant reductions in environmental space, costs, and operational complexities. The results highlight the potential benefits of adopting a closed system approach, including lower facility costs, simplified operations, and enhanced sterility assurance.

In conclusion, he underscores the challenges and benefits of implementing closed systems in biomanufacturing. While the transition requires a paradigm shift and enhanced skillsets, the potential gains in cost reduction, operational efficiency, and risk mitigation make a compelling case for embracing closed systems in the industry.

Key Takeaways

• Closed systems in biomanufacturing have evolved over two decades as a crucial risk mitigation strategy.
• Global regulatory agencies emphasize product protection and patient safety through closed systems.
• Understanding potential contamination sources is crucial, and closure boundaries define primary and secondary system barriers.
• Treating each unit operation as a unique closed system is essential, with a focus on open aseptic operations.
• A case study demonstrates significant benefits, including reduced costs, simplified operations, and enhanced sterility assurance, by transitioning to closed systems