Have you ever tried to predict how long sublimation will take for the very first feasibility lyophilization cycle? Wouldn’t it be nice to anticipate primary drying time to not mess up this very important test lyophilization by choosing a too short time and end up with a wet product?
ProJect Pharmaceutics is specialized in lyophilization process development for injectables. One of our new customers, who did not know us yet, was very nervous once the project moved towards the first feasibility lyophilization cycle for his drug product on a Friday afternoon. He tried in approximate way to calculate a time that was not too conservative on the one hand, but also not too short on the other hand, in order to answer as many questions as possible in this first cycle. Pragmatic as our development team is, we offered to simply switch the cycle to secondary drying when primary drying was complete. He wondered how this might be possible over the weekend without shift operation. We disclosed that – thanks to modern PAT (process analytical technology) – we can control our freeze dryers from home and simply switch his cycle one step further on Sunday morning over a morning coffee. Instead of calculating, we simply test how long it takes.
Our customer was highly delighted with such simple pragmatism, which he hasn’t encountered yet in the pharmaceutical industry.
