Scientific conception of freezing steps as a part of pharmaceutical platform technologies.

The development of new active agents as recombinant protein is a costly and time-consuming process. After finding the right target there is a lot of R&D work left to identify and optimize the upstream and downstream process before the biologics enter the preclinical and clinical studies. To ensure long term product stability for the case of storage and transport processes often a freezing step is required. Unfortunately, the freezing process itself may influence the product stability in a drastic manner. In that case a preclinical and clinical study is doomed to become a failure. Up to now the optimization of product stability in freezing steps is a costly and time-consuming issue which may require multiple freezing experiments. Our studies have shown that proteins are solely damaged by concentration effects and pH shifts and not directly by thermal effects. If one concerns that only the re-distribution of solute concentrations depending on the freezing, a measurement of the damage potential at ambient temperature is allowed. This scientific know-how enables us to develop a rapid screening method of product quality for the simulation of product loss in freezing steps ― without costly and time-consuming multiple freezing experiments.