The application of MicroCal VP Capillary DSC at a contract development organization
A case study involving the formulation development of a monoclonal antibody is presented to detail the utility and potential limitations of DSC in support of preformulation for a variety of protein products.
Introduction
Although biopharmaceuticals represent a rapidly growing segment for ethical products, the ability to progress these products from research to development and ultimately manufactured products can be hindered by the complex structures and multiple degradation pathways that are associated with biopolymers.1,2,3
Traditional pharmaceutical development has often relied on real-time stability studies and standard analytics to develop product formulations that confer the two year shelf life typically required for drug products. Although these approaches have proven useful, there is a need to develop and apply techniques that report on the structural stability of biopharmaceuticals and reduce the need to rely on real-time stability studies so extensively. Differential scanning calorimetry, which monitors the apparent excess heat capacity of a protein solution as a function of temperature, is one of several tools that have been proven to be useful in this setting.4,5 Even when used in a comparative or rank-ordered fashion DSC can provide data on protein stability that correlates well with real-time stability studies.
