Chapter 3 - Biopharmaceutical industry's biophysical toolbox

Abstract

To acquire information about a protein drugs higher order structure (HOS) is a challenging task. Over the years, many biophysical tools have been developed to extract as much information in this area as possible. However, only a very few of these biophysical tools are capable of directly providing detailed information at the atomic level. While these tools are extremely useful in academia and in the research departments of biopharmaceutical companies, some have attributes that make them unsuitable for use in the process development sector of the biopharmaceutical industry. Hence an alternative approach for assessing information about the HOS of a biopharmaceutical in the process development area has been employed. The basis of the strategy is to make use of methodology that can easily be employed on a routine basis that quickly process many samples to yield indirect information that characterize their biophysical properties. Using a range of different but much simpler biophysical tools, more practical methods for assessing HOS information can be realized, albeit at a much lower resolution, which better satisfies the working environment needs of the biopharmaceutical industry's process development area. In this chapter, we take a brief survey look at these biophysical tools and their varying capabilities.