Cold Chain Fundamentals for ATMP Launch
With the growing demand for advanced therapy medicinal products (ATMPs) in the pharmaceutical industry, contract development and manufacturing organisations (CDMOs) are under pressure to meet expectations and adopt the latest technological advances to enhance the efficiency and reliability of the cold chain.
The pharmaceutical cold chain sector plays a crucial role in ensuring the safe and effective delivery of temperature-sensitive medications.
At Almac, we optimise our cold chain logistics to deliver our clients’ product to the patient within as little as 20 hours. For companies preparing to launch ATMPs, understanding the fundamentals of cold chain management is essential.
Temperature sensitive transport:
Maintaining product efficacy is critical, especially for therapies with short shelf lives and sensitivity to temperature and humidity. As a core component of the cold chain, this typically involves vehicles equipped with state-of-the-art cooling systems and real-time monitoring to provide continuous data on environmental conditions.
Differing products have varying degrees of temperature sensitivity due to the nature of the API. Because of this, we work closely with trusted supply chain partners for a comprehensive and expedited delivery process and provide access to customisable, dedicated packaging and storage facilities to meet our clients’ unique needs.
Packaging Solutions
To mitigate temperature fluctuations between each phase of the cold chain, CDMOs turned towards packaging design to maintain the desired temperature of the product. This includes packaging and labelling over dry ice within a controlled environment with consistent time logs to monitor time out of condition. At our Almac US and EU facilities, we offer dry ice labelling and packaging in temperatures ranging between -20° to -80°c as well as country-specific packaging with patient specific information for weight-based Gene Therapy products.
Data loggers and sensors
We partner with innovative shippers that utilise temperature monitors, providing visibility into product and shipping conditions and location of shipments. This data is then collated into a central digital platform to ensure compliance to regulatory and quality standards.
CDMOs use data loggers and sensors to continuously monitor temperature, humidity, and shock throughout the supply chain. These devices are placed inside packaging or attached to pallets and if conditions deviate from specific stages of the supply chain, it provides real time data allowing for immediate corrective action.
Our expertise in ATMPs mean that we understand the specific needs of each product and continuously work according to its needs by managing the time spent out of temperature and maintain the efficacy of the drug product.
Transporting ATMPs through the supply chain presents challenges due to the need of strict environmental controls. CDMOs address these challenges through expedited launch, tailored logistics and real-time tracking for full shipment visibility.
By leveraging advanced cold chain logistics, CDMOs like Almac ensure these sensitive therapies reach patients safely and efficiently. As the industry evolves, CDMOs continue to drive improvements throughout the supply chain and maintaining integrity of the cold chain.
