药品包装
产品(数学)
过程(计算)
容器(类型理论)
废物管理
工艺工程
风险分析(工程)
计算机科学
运营管理
工程类
业务
医学
数学
机械工程
操作系统
放射科
几何学
作者
William J. Rayfield,William S. McKechnie,Sunitha Kandula
标识
DOI:10.1016/j.xphs.2020.12.019
摘要
Abstract
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™ container and previously characterized CelsiusPak® 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.
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