Secrets to Packaging Ultra Low Temperature Products: What Every Manufacturer Should Know

Advanced Therapy Medicinal Products (ATMPs) offer ground-breaking opportunities for treating injuries and disease, in particular for cases of severe, untreatable or chronic diseases that do not respond adequately to more conventional treatments. In many cases, these treatments are curative, making them life altering and even lifesaving.

These products, which include cell and gene therapies (CGT) and some COVID-19 vaccines, for example, typically have very rigid temperature requirements that pose unique challenges throughout the supply chain. Often, they must be held at ultra-low temperatures (ULT) between -20 and -80 degrees Celsius, with very little scope or time for deviation away from these target temperatures.

The risks of temperature excursions during shipping have been minimised successfully with special packaging and temperature tracking. However, steps must also be taken during labelling and packaging to ensure that ATMPs stay well within their acceptable temperature ranges. Appropriate processing requires careful planning, experimentation and validation, tight controls, and extreme caution.

While the onus is on Contract Development and Manufacturing Organizations (CDMOs), such as Almac Pharma Services, to handle these products correctly, drug manufacturers should be aware of the risks and complications involved in every step of the supply chain. They must ensure that their CDMO has the expertise to control for, and mitigate against, the risks.