Case Study

Innovative Clinical Supply Solutions - Cold Chain

cold thermometer cold chain temperature controll

A biopharmaceutical company known for the development of novel therapeutic drugs had a critical requirement to package a biohazardous frozen drug product. However, the client possessed no stability data at the project onset; an essential parameter in determining the need to keep the product frozen. Having achieved outstanding results in prior work with Catalent, the client had the confidence to engage Catalent’s Clinical Packaging, Storage and Distribution assistance.

With a one-minute limitation on the time the product could be out of frozen conditions, Catalent packaging experts and extensive cold chain capabilities were called upon to create a custom packaging/distribution concept to meet the client’s needs.

Project Snapshot

The Challenge: Normally, stability data is collected and evaluated prior to the product packaging stage. As a result, Catalent was challenged to deal with multiple issues. In addition to the need for special handling of the frozen biohazardous product, accommodation to the zero time exposure at room temperature was a serious consideration.

The catalent solution Catalent’s Project Manager led the project team and together, they held collaborative sessions with the client to find the best solutions to overcoming the challenges of this project. As a result, a custom designed shallowdepth, dry ice cooler system was found to be the optimal solution. In contrast, Catalent typically can conduct frozen packaging projects in walk-in freezers.

Figure 1

The vials of product were delivered to the packaging room in dry ice-filled coolers (figure 1). An efficient packaging line was set up so that coolers could be maintained at a temperature under -20°C. As the coolers passed from one technician to another, the ambient temperature was maintained throughout the process, including the time needed for label applications. For applying labels, a strong adhesive was required for effectiveness on the frozen vials. The technician had to apply hand pressure in affixing the labels which had undergone a 24-hour test in frozen conditions to ensure adherence to frozen glass. Normally, an automated or semi-automated labeling process is used, but that was not possible with a frozen product where manual labeling was essential.

Figure 2
In all cases, there was careful inspection of the labels for actives and placebos as shown in figure 2. Another advantage of the customized coolers was the protection it afforded in the packaging line. If the biohazardous drug was accidentally dropped, it fell into the cooler, a contained area. Every step of the process required handling over dry ice, including placing the unit in kits. The kits were then delivered to Catalent’s clinical storage and distribution
area where the shipment process was performed using a walk-in freezer.

 

 

Conclusion

The client reported that they were exceptionally satisfied working with Catalent, and were impressed with Catalent’s ability to find effective solutions to their somewhat unusual requirements. The client especially found high value in their interaction with the Project Manager. In addition to providing a customized solution and creating a new methodology for packing that met specific and strict parameters, they recognized that it was the Project Manager who worked with internal resources to make it happen. The client enjoyed peace of mind in being able to monitor every step of the process, engaging in frequent communication with the Project Manager, who wanted to make sure they approved of the way the project was progressing. At Catalent, it’s all about how people and service come together.