Biological comparability can be assessed by examining the physiochemical, pre-clinical and clinical characteristics of the molecule. Biopharmaceutical comparability studies directed at observing higher order structure and structural dynamics can be performed by H/D-Exchange Mass Spectrometry analysis.
Regulatory agencies have been asking for more mass spectrometry based techniques to be used to generate data which should be included in submissions to the various agencies. These statements coupled with the recent draft Biosimilar Guidance issued by the FDA, is starting to have both innovators and biosimilar manufacturers take a long look at the valuable data that H/D-Exchange can provide.
ExSAR offers the following H/D-Exchange analytical services: