With 59.4% of manufactured drug substances being in a frozen state prior to shipping, it is not surprising that over recent years freeze-thaw technology has been scrutinized for efficiency, not only for the physical act of freezing and the effect it may have, but also the processes surrounding it – filling, storing, transporting, thawing and traceability. It is paramount that high value product – both in terms of money and patient safety – is given priority so that it can reach patients quickly, while maintaining the safety, efficacy and activity profile, using economically sound processes and technologies. With this in mind, the conventional static freezing methods need to be weighed against the potential advantages of alternative approaches such as plate freezing technology.
Do we dare treat drug substance freezing as an isolated process? Or should freezing be integrated with bulk filling, storage, shipping, thawing and fill-finish operations to deliver a multi-site end-to-end process that is inherently seamless and equally capable of assuring consistent product quality and safeguarding valuable product? In this paper review integrated solutions to minimize risk and preserve product quality.