It was determined that many of the Bovine Serum Albumin (BSA) reference candidates did not exhibit acceptable activity after inclusion into the final product though all purchased samples shared the same name and identification. The inconsistency in activity causes delays, increases cost of manufacture, and adds an element of variability. Current in-house biophysical techniques fail to correctly identify the inactive candidates prior to product inclusion due to inconclusive results or a lack of sensitivity. Thus a more accurate, reliable analytical…

A rapid increase in the number of companies working on the development and registration of biosimilars and the need to get these products to market with speed has lead biosimilar developers to turn to contract research organizations (CROs) when they lack either the internal capability or capacity for conducting certain work. Throughout the biosimilar development pathway, a product sponsor can choose to conduct the work itself or use service contractors. Contractors can be niche providers of a single aspect of…

nanoDSF determines thermal and chemical protein stability with ultra-high resolution and with unmatched reproducibility. The detection of the intrinsic tryptophan fluorescence enables measurements at close-to-native conditions in any buffer, even in the presence of detergents. nanoDSF is applied in antibody engineering, membrane protein research, formulation and quality control.