“…It is possible to employ light obscuration method of USP <788> for detection of particles, including protein aggregates in inhaled products, as a simple and robust approach for formulation and/or process screening purposes. For instance, the detection of higher levels of soluble and/or insoluble protein aggregates post nebulization or spray drying indicates that the formulation and/or the drying process led to protein unfolding and denaturation 8 , 15 , 31 , 32 . The analytical testing for protein aggregates should be designed to prevent creation or reduction of protein aggregation during sample collection 33 or handling 27 .…”