Considerations for Implementation of a New Drug Substance Container for Subzero Storage

Therapeutic manufacturing has become globalized in recent decades, necessitating transportation of drug substance across the world. The outcome of this expansion is significant costs for shipment and added risk of damage to the drug substance containers. There are multiple container options with various materials of construction for storage of Biologics drug substance (DS). This study evaluates a newly designed CryoVault (TM) container and previously characterized CelsiusPak (R) bag container using a well-represented scale-down model. Consideration of an appropriate storage container includes the risk assessment of the design and material of construction, which can potentially impact product quality attributes, stability and container leachables. An extensive data package, including product stability over time and temperature with respect to impact of extractables and leachables from different containers undergoing a typical one freeze/thaw cycle process was evaluated. This drove to the decision for implementation of a container into the drug substance manufacturing process. (C) 2021 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.

Automated summary

Therapeutic manufacturing has become globalized in recent decades, leading to the need for transportation of drug substance worldwide. A study compared a newly designed CryoVault(TM) container with a previously characterized CelsiusPak(R) bag container to evaluate their impact on product quality attributes and stability. The decision for implementing a container into the drug substance manufacturing process was based on the extensive data package regarding container effects during freeze/thaw cycles.