Using Differential Scanning Calorimetry (DSC) to optimize antibody manufacturing
In this white paper, we report the use of the thermal stability data obtained from DSC to screen conditions for viral inactivation of an antibody1.
sponsored by Malvern Panalytical
This information provides a quick and easy stability assay during the manufacturing process. For the antibody studied here, the apparent Tm data from DSC was key to the recommendation to increase storage pH immediately after viral inactivation, resulting in increased structural stability. This example illustrates the crucial role of DSC and thermodynamic analysis during therapeutic protein development.
Overview
There are many challenges to overcome when developing manufacturing processes for proteins intended as therapeutics. Most notably, project timelines and limited initial availability of material drive the need for rapid, robust, and sensitive process development tools. Manufacturing steps are routinely evaluated and optimized to improve protein yield, reduce production time, and increase long-term stability of final drug product. Any improvements in final yield and stability are vastly important in both process and manufacturing economics. Conversely, a failure at any step in production, resulting in decreased yield and/or stability, will result in a financial loss.
