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.
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.
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.
Resources

The Spontaneous Infection: Did you leave the back door to your cultivation suite open?

How to appropriately classify your cleanroom at early-stage design

Closed systems: How much harm can a single droplet do? Considerations for a viral inactivation step

Shared clean-in-place systems: to share or not to share Release Date

Closure analysis of a mock autologous cell therapy process