Chapter 4 - An Introduction and Hierarchical Organization of the Biophysical Tool in Section II

Abstract

This chapter provides a brief introduction and hierarchical overview of the biophysical tools to be discussed in Section II of this book. In choosing these tools, we have organized them into a hierarchy of four separate levels (i.e., four tiers). The key criteria for this organization, concerns the richness in information each tool supplies regarding the biophysical properties and higher order structure of a protein drug. In using this key criterion a number of factors were observed to trend with this organization, including: (1) ease to operate and use, (2) cost to implement, (3) required amount of time to upset and acquire data, and (4) level of expertise to process, analyze and interpret data. The biophysical tools at the lowest two tiers (i.e., tier 1 and 2) fall into a general grouping that constitutes the standard or mainstream package of commonly used biophysical tools employed by nearly all biopharmaceutical companies in developing protein drugs. While the biophysical tools in the two highest tiers (i.e., tier 3 and 4), comprise a second grouping of methods that correspond to the more advanced biophysical tools.