The Impact of Process Closure on Biomanufacturing Risk

By Jeffery N. Odum, CPIP
Volume 22, Open Access (September 2023)

“Closed system.” The term itself appears deceptively simple. However, the definition of a closed system, its implementation, and its impact on biomanufacturing has been anything but straightforward.

The journey toward implementing closed systems spans over 20 years. The concept of closed systems was introduced in January 2000 with the draft issue of ICH Q7. Since then, other industry guidance documents emerged, defining and supporting process/system closure as a primary means of risk mitigation to meet the baseline requirement of protecting the product, as defined in cGMP.

Presently, global regulatory agencies recognize three distinct definitions of a closed system. These definitions, found in EU Annex 1, EU Annex 2, and the PIC Annex 2A, all focus on product protection where the product is not exposed to the immediate room environment during manufacturing. This is where the journey begins.

Odum JN. The impact of process closure on biomanufacturing risk. BioProcess J, 2023; 22.

Posted online September 12, 2023.