Analytical Characterization of Biosimilars Poster
In case you missed SGS’s poster presentation at the AAPS National Biotechnology Conference this past May, you can still view it here.
Author: Fiona Greer, SGS M-Scan
Purpose: Any manufacturer seeking to develop and market a biosimilar product requires comprehensive physicochemical structural characterization of the (glyco)protein. For biosimilar products, this task should be performed at three distinct stages of development. Initially, batches of the target originator molecule should be studied to determine the exact sequence of the target protein, the post-translational modifications and the variability of quality attributes in batches over time. Then, once the biosimilar product is manufactured, characterization needs to be performed to confirm its structure. Finally, manufacturers must provide comparative data for the biosimilar side-by-side with the originator molecule as required by various regulatory guidelines.