Stabilisation of biopharmaceutical products and finished product formulations

Abstract

This chapter overviews the stabilization of protein-based biopharmaceuticals. Finished biopharmaceutical products must have the required stability from a clinical and regulatory point of view. Furthermore, the stability profile should cover the manufacturing and marketing cycles of the product to minimise costs. The major routes by which proteins may be degraded are outlined. A brief description of biopharmaceutical production processes is provided to acquaint the reader with issues relating to stabilisation during processing. The basic principles of how in-process material and fmished product may be stabilized are presented. Finally, a table of major constituents in approved biopharmaceuticals is included at the end of the chapter to illustrate how stabilisation principles have been put to practice to date.