Rapid Scale-Up Of Cold Chain Operations In Drug Development And Manufacturing

By Muhammad Siddiqui, Entegris

Reliable cold chain supply, from pharmaceutical API through to end product, often is misunderstood or treated as an afterthought: “freeze it and forget it.” However, as more temperature-sensitive therapeutics are formulated and manufactured, manufacturers must prioritize frozen storage and cold chain shipping as an individual unit operation. Like any other effective unit operation, cold chain operations require thoughtful planning, risk assessment, and investment as well as accurate data collection. 

In general, demand for cold chain operations has been increasing for years, parallel with an increase in biological therapeutics that are temperature-sensitive, from vaccines to cell-and-gene therapies. While some organizations already have noted this trend and have begun planning cold chain operations for future projects, others have been reactive to the process of scaling up their cold chain. Regardless of where an organization starts, the same principles, the same considerations, and the same risks apply.