Challenges with the biophysical characterization of complex (multi-chain assembly, chemically modified, big and high concentration) biopharmaceuticals

Abstract With the first commercial approval of a simply and small recombinant protein biopharmaceutical called Humulin (a copy of insulin) in Oct. of 1982, the development of biopharmaceuticals has proceeded down a road of ever increasing complexity. In this chapter we take a brief journey down that road to explore some the avenues that protein biopharmaceutical development has, is and will be going in providing better health care. Along the way we will take a look at the challenges that need to be met and some of the biophysical tools that are being used and developed to overcome these challenges.