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Cryoport Practices Quality by Design (QbD) Approaches When Developing New Products and Processes

Thu, Apr 13, 2017

Cryoport is the industry’s most trusted provider of cold chain logistics solutions for temperature-sensitive life sciences materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. The company stands alone and is truly unrivaled due to their continuous improvement of their products and processes by executing advantageous Quality by Design (QbD) practices in support of their logistics solutions.

Cryoport’s exclusive Express® Shippers are not only validated using the traditional approach but are qualified through a comprehensive Quality by Design model. Their model is based off of a Holding Time Variation study that defines characteristics that can impact the performance of a shipper. 

By using current scientific technology and methodologies, Cryoport has developed models to dynamically predict the impact of multiple factors on holding time for Cryoport products. As data is collected and evaluated in real time, Cryoport can modify the impact of external events on anticipated hold time. Additionally, Cryoport continues to strive on improvement of those models to reduce risk to client shipments and commodities.

Cryoport also diligently qualifies each shipper from their dewar fleet prior to leaving their facility and upon its return. Each individual shipper has its own unit level historical performance record and data collection that defines the quality and functional state. If a shipper does not meet the criteria Cryoport has set forth in their processes, it will be removed from service.

Cryoport’s new and state-of-the-art flagship shipper, the EXP-6 Dry Vapor Shipper, was designed and engineered from their comprehensive QbD approaches as well. The new shipper has a number of new features that have been developed to provide the latest advancements in Cryogenic shipping. The new shipper also was designed to improve hold-time and to enhance even more logistics flexibility.

With their continuous use of Quality by Design practices, Cryoport is your end-to-end cold chain logistics partner that provides the most comprehensive logistics platform to mitigate risk and ensure the quality of your materials. When the future of your product, research, therapy or patients is on the line, you want to place it in the hands of a partner you can trust.

Read our blog for the latest news on cold chain logistics issues.