Sreedhara Alavattam

Biophysical Analysis in Support of Development of Protein Pharmaceuticals

Development of proteins as pharmaceuticals is more challenging compared to traditional small molecule drugs because of the increased complexity of the chemical and physical stability of protein pharmaceuticals. This necessitates the use of both analytical and biophysical methods to investigate the stability of proteins. The choice of which biophysical methods to use is dictated by the types of studies and specific requirements that support protein drug development. This chapter discusses the various types of biophysical studies that are often performed during protein formulation development including (1) early screening assessments, (2) intense characterization, and (3) confirmatory studies. Case studies with representative examples from Genentech are presented for each of the above topics.