Case Study: Frozen Drug Packaging

A biopharmaceutical company known for the development of novel therapeutic drugs had a pressing requirement to package a biohazardous frozen drug product. Having worked previously with Aptuit and having experienced excellent results, the client had the confidence to engage Aptuit's Clinical Packaging and Logistics assistance. The project was conducted at Aptuit's facility in Allendale, New Jersey.

The client had no stability data, an essential parameter in determining the need to keep the product frozen. There was a one-minute limitation confining the length of time when the product would be out of frozen conditions. Handling, labeling and packaging the product necessitated that Aptuit design a custom-created packaging/distribution concept to accommodate the limited exposure to room temperature conditions. The Aptuit Team assigned to the project consisted of packaging experts who were led by a dedicated Project Manager.

For the Phase I Study, 3 mL vials of 60 actives and 60 placebos were packaged. A total of four separate package runs were tested and evaluated over a twoyear period that began in 2005. Throughout the duration of the project, the client was able to monitor the progress, significantly observing the careful handling and filling of the customized cooler which was designed to address the specific requirements of working with the biohazardous frozen drug product.