Closure playbook

Overview

The creation of closed systems allows the opportunity for innovation when designing new biologic facilities, as the need for environmental control is reduced. Closed systems technology has been readily available for some time; however, facility design has not advanced at the same pace.

Designs based on closed systems within a controlled not classified space are quicker and cheaper to build. Fundamentally they offer greater patient protection and provide a higher quality of product for patients.

The BioPhorum closure playbook has been developed to help optimize decision making when designing, constructing, or modifying a biomanufacturing facility or process. The playbook implements globally recognized terminology, focused on current US FDA guidance, including the baseline definitions around system closure.

The primary principle for this playbook is to utilize a risk-based approach to determine key facility and process attributes and controls, such as room classification, viral segregation, gowning, cleaning, environmental monitoring, and sampling. Utilizing a risk-based approach recognizes that the environment surrounding a process is only one of several protection layers, which may contribute to the overall product quality, and therefore patient’s health. This approach allows companies to leverage recent advancements in process closure technologies (e.g., single-use bags, connectors, filters, assemblies) as part of an industry-recognized framework.

Benefits

The playbook defines tools, steps and documents required to assess risk and qualify biomanufacturing facilities that make use of closed-system technologies. By following the methodology in the playbook, significant gains can be made in reducing the time to deliver these facilities, as well as associated CAPEX and OPEX costs, by embracing closed systems in a CNC environment.

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Scope of the closure playbook

This resource is a roadmap for biopharmaceutical manufacturers, and their partners, to support developing, assessing and verifying unit operations leading to an appropriate facility design that is “right classified”. The playbook provides technical and operational solutions in the form of specific tools, examples, and approaches to assist companies in executing and documenting system closure risk assessment and verification, to develop the strategy for facility design of modern, flexible biomanufacturing facilities.

It addresses traditional mab-based cell culture operations, new ATMP-based platforms such as cell and gene therapies, and clinical and commercial manufacturing scales of operation for both stainless steel and single-use based operations.