CryoVault® Freeze & Thaw Platform CryoVault® is a scalable, robust, completely single-use freeze and thaw platform for biopharmaceuticals. This endto-end solution provides the industry leading implementation of this demanding unit processing operation. CryoVault® can be seamlessly scaled from process development through clinical to full scale commercial production. Consistency in freeze-thaw performance throughout the various scales of operation is a key performance attribute of the system. The platform is not only scalable from a freeze-thaw performance perspective, but also from an operational...

Modular Platform CryoVault® is a modular freeze and thaw platform composed of four components. MATERIAL HANDLING COMPONENTS 1 Single-Use Assemblies The single-use assemblies are rigid HDPE containers with configurable fluid path assemblies referred to as top works. The containers feature a consistent freeze-path length throughout the different sizes to ensure process scalability. Single-use assemblies are currently available in the following volumes: Process Development and Stability Scale (30 mL nominal working volume) Clinical and Production Scale (100 mL nominal working volume) (16 L nominal...

2 Freeze/Thaw Components There are two primary clinical and commercial production scale freezer options for the CryoVault® platform. The large scale freezer can accommodate up to four containers of 100 L, totaling a 300 L nominal working volume, or sixteen single-use containers of 20 L, totaling 256 L of nominal working volume, or any combination of 100 L and 20 L containers. The smaller scale freezer is available to accommodate up to a 96 L nominal working volume or six single-use containers of 20 L. Both freezers are programmable to provide fully controlled freeze and thaw cycles. Agitation,...