Analysis of inhalable products
In cooperation with our customers, we have gained extensive experience in the determination of Aerodynamic Particle Size Distribution (APSD) and Delivered Dose (DD) for Dry Powder Inhalers (DPI) and Metered Dose Inhalers (MDI). In addition to the investments in Anderson Cascade Impactors, Next Generation Impactors and the establishment of a dedicated humidity and temperature controlled lab, we have established a permanent team of specialists to deal with many questions related to inhalable drugs.
Our broad analytical experience and capability enable us to extend this service to LNP formulated mRNA and DNA based therapeutics and other types of molecular entities in nano-particle formulations.
These manually, complex and time-consuming analytical tests are well suited for external contracting, because it ties up extensive personnel and instrumental capacities. Our customers welcome the use of these services for stability testing and analytics supporting product development, in order to free up internal capacities for innovations.
We also support our customers with our many years of experience in the field of extractable & leachable testing of primary packaging materials, as well as components of inhaler systems, that come into contact with the product. Our experience also encompasses the development and validation of methods for release testing of inhaler components with product contact.
We therefore also offer an ideal one-stop-shop solution for our customers projects in the area of inhaled drug product development.
More about inhalative analytics
More about extractable & leachable tests