Figures & data
Figure 1. Diagram depicting the contributing factors from the drug product, conditions and contacts that contribute to the analytical quality and performance measures.
Table 1. Summary of inhaled antibody therapeutics noted primarily in clinicaltrials.gov
Figure 2. Environmental and product factors that contribute to the quality and performance of inhaled monoclonal antibodies that are uses to assure efficacy and safety outcomes.
Table 2. Methods of assessing the stability of antibody therapeutics. *Aggregation and concurrent loss or decrease in activity/function are the most common sources of instability during aerosolization or upon contact with collection surfaces
Table 3. Devices/components that serve a specific process in drug product performance and characterization and the components into which the drug (mAb) will come into contact
Figure 3. Images of: (a) Next generation impactor showing collection cups (lower section); (b) assembled Andersen 8-stage non-viable impactor with collection plates (below) that are present on each stage and; (c) two-stage liquid impinger showing glass vessels in which samples are collected.
Figure 4. Schematic of droplet behavior following aerosol generation in transit through the airways and upon deposition based on their colligative properties and water activity.
