A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics.

The Challenge

The complexities of different aspects of the project required a seamless integrated effort to successfully support the product development of a spray dried hygroscopic protein formulation.

The Aptuit Solution

Aptuit’s first step was the appointment of an Aptuit Project Manager to oversee the project, linking together the multiple services that were required. The Project Manager served to keep the entire project on track, conforming to a realistic schedule and representing a single voice to the client. The work was conducted at Aptuit’s Herriot Watt University Research Park facility in Riccarton, Edinburgh, Scotland. Significantly, more than one third of the analytical scientists within the physical and analytical chemistry department are dedicated to the testing of respiratory products. The analytical expertise from this dedicated pool developed and validated methodology that was needed for drug product characterisation release testing, and clinical stability testing at each phase of the products development. They developed and implemented environmentally controlled containment (20°C/<5%RH) cabinets to facilitate the handling of the material from both a manufacturing and analytical perspective. Working closely with a vendor, they aided the design from an operational perspective and validated state of the art environmental cabinets for analytical performance testing i.e. particle size distribution and dose content uniformity. Aptuit provided a document management platform via the use of Sharepoint so that the client had instant access to data and other project documentation.

Shown left in Figure 1 is Aptuit’s Riccarton facility in Edinburgh, where one third of the scientists involved in analytical projects are respiratory specialists.

Aptuit worked closely with a vendor to design and oversee the construction of validated stateof- the-art environmental cabinets (Figure 2) for the analytical performance testing i.e. particle size distribution and dose content uniformity of the drug product.

Conclusion

The client reports that Aptuit is facilitating their ultimate goal of delivering their product to market. They indicate that the role of the project manager enables the ongoing communication that is essential to the success of the project and the confidence that they are working in true partnership. Aptuit is providing a fully integrated service that showcases our professional, integrated approach to providing our client with solutions. The attributes of our operational groups are particularly notable for our focused respiratory science expertise and problem solving/root cause analysis capabilities. At Aptuit, it’s all about the science.