For the experts

The formulation job is not done until storage stability trials have proven that the enzyme product maintains its activity over the required period of time.

​​We use a wide range of analytical tools such as DSC (differential scanning calorimetry), analytical assays, light scattering, and microscopy to characterize our products, both at the time of production and in storage. A common challenge is to adapt the methods to the matrix of the enzyme formulation because the enzyme protein only constitutes a few percent or less of the total formulation.

Quality parameters such as particle size distribution and color can be assessed immediately after the solid or liquid product has been produced. The situation is quite different for storage stability, where only time will tell whether the product meets the stability goals.
As enzyme products typically need to maintain their activity for months to years, much effort is devoted to developing accelerated methods that allow long-term stability to be predicted based on short-term data, but obviously the data generated by accelerated methods are substantiated by real-time data over time.

Formulation of the enzyme product – be it in a solid or liquid form – will generally make the enzyme product stable for many months or even years.