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.

The Challenge

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.

The Aptuit Solution

A large team of highly skilled scientists, specifically dedicated to respiratory product analysis, was assigned to this project. The team took a strategic approach to method development and validation using method development software in conjunction with ultra performance liquid chromatography systems (uPLC), enabling Aptuit to deliver one common method for both chemical and performance methodology. State of the art stability suites were employed and managed by a dedicated stability management team. Aptuit’s comprehensive inventory of advanced analytical equipment specific to testing inhaled products was used. Aptuit utilised data management software which is 21CFR part 11 compliant and created bespoke report definition files which were used to present data into its reportable form. A seamless integration of information systems was set up between Aptuit and the client, facilitating “real time” access to approved stability data.

An environmentally controlled cabinet, as shown in Figure 1, was used for the performance testing of inhaled devices.

In this large scale stability study, the latest ultra high performance liquid chromatography, as shown in Figure 2, was used for the quantification of samples.

Figure 3 represents a stability storage suite employed by Aptuit in stability studies such as described herein.

Conclusion

A large group of respiratory scientists, more than one-third of the physical and analytical chemistry department at the Aptuit Edinburgh facility, met the expectations of their client regarding the development and validation of chemical and performance methodology. The client was satisfied that large scale stability studies were effectively coordinated and managed to facilitate the efficient testing, acquisition and reporting of late phase stability data for regulatory submission. At Aptuit, it’s all about the science.