Physicochemical Characterization of Biologics
As a mandate from Department Of Biotechnology (DBT), Govt. of India, C-CAMP has set up a comprehensive physicochemical characterization facility for biologics/ biosimilars using state-of-the-art instrumentation and standard operating protocols (SOPs). Biological entities, unlike small molecule based pharmaceuticals are very complex in nature.
Biopharmaceuticals can exhibit tremendous heterogeneity in terms of posttranslational modifications (PTMs) such as glycosylation, oxidation, deamidation, phosphorylation etc. and structural modifications. In addition to this, changes in upstream and downstream processes during recombinant production of biologics also influence structural heterogeneity. Therefore, comprehensive characterization of biologics is necessary to ensure safety and efficacy.