New analytical methods for the assessment of the physical stability of therapeutical proteins

Guidelines regarding particulate matter in parenteral solutions require monitoring of particles >=10 µm and particles >=25 µm. These size ranges are leftovers from ancient guidelines and seem to be inadequate for protein pharmaceuticals nowadays. During the last years, the need of implementing new pharmacopoeial methods has been discussed, such as Microflow Imaging. At least subvisible particles in the range from 1 µm till 10 µm should be monitored additionally.