Stability studies are an integral part of all development activities. Usually, stability must be assessed at the recommended storage temperature, what is typically 2-8°C for biologics. To securely claim a shelf life of two years the stability needs to be observed over long periods of time, what is often challenging due to increasingly aggressive project timelines. In addition, if CQAs run out of specification this often becomes clear at late stages of a stability study, exacerbating the situation even more as time for new studies is lacking.
Thermokinetic modeling is providing a solution for this dilemma. With an appropriate short-term stability study of only 12 weeks the stability behavior of a given product can be reliably predicted. A case study using a standard mAb confirms that such thermokinetic models accurately describe the stability behavior for the entire shelf-life of the product using historic QC data for comparison.
In addition, thermokinetics can be used to model stability in time-consuming temperature excursion experiments, deliver estimates for hold-times during manufacturing or compare degradation in different packaging containers. Thermokinetic modelling is a versatile and reliable tool for early knowledge of stability outcomes, boosts the probability of project success and is therefore routinely used in development.