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Pharmaceutical Manufacturing and Packing Sourcer

A Cold Case

Patient safety will always be the top priority of every clinical trial. Therefore, it is vital that the investigational medicine dispensed to the patient is pure, safe, and effective no matter what challenges are presented by packaging, storage, and distribution requirements.

Many medicines have a stringent stability profile, where the acceptable temperature range in which the drug must be stored and distributed is strictly dictated to ensure the product remains safe and effective. This is becoming the norm rather than the exception, with large molecules and biologic medicines now playing a more prominent role in clinical development. Therefore, ensuring the biologics are optimally safe and effective is often an issue of sustaining the product at very specific temperatures and maintaining these requisites despite what can be differing, and even extreme, environmental conditions.

To control the temperature conditions of the drug at every step in the supply chain, it is critical that trial sponsors consider a range of factors. From the point in time that the drug is first manufactured through to the end delivery to the patient, it will be exposed to a multitude of environments during its lifecycle. Stages of this will include initial packaging, storage at the distribution facility, clinical site transportation and storage, and distribution to the patient.

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Brian Keesee, Vice President and General Manager of PCI’s Global Clinical Operations and Supply, has spent his entire career in the pharma industry. In his current role, Brian is responsible for global clinical operations and project management, including PCI’s stateof- the-art packaging and distribution facilities located in Rockford, US, and Bridgend, UK.
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