Case Study: Large Scale Stability

As a drug product enters into the later clinical phases, there is a requirement to support large registration stability studies. A large European client sought Aptuit's substantial resources to conduct large scale stability testing. Although there are a few other service providers with the capabilities to support large pharmaceutical organizations in these studies, Aptuit offers an added competency because of its large team of dedicated respiratory scientists. This exceptional capability allows Aptuit to commit to extensive analytical work that ensures data integrity and consistently provides on time delivery.

Aptuit was called on to achieve a complex span of deliverables within very tight deadlines. We were charged to develop and validate chemical and performance methodology to Phase III to support a registration stability study. Across the shelf life of the product, over a three-year period, Aptuit was required to provide effective study designs, study logistics, and the labeling and storage of stability samples. The generation, interpretation and delivery of large quantities of stability data associated with late phase registration stability studies were needed.