The units in this module were selected to give students a good understanding of the fundamental principles associated with biopharmaceutical manufacture. The module begins by discussing basic fermentation principles for the large-scale culture of bacterial and mammalian cells to produce recombinant protein pharmaceuticals. This is followed by a thorough study of the main unit operations associated with product recovery, commonly referred to as downstream processes. The third unit covers modern methods of product characterisation, which forms a critical component of the regulatory procedure. The final unit considers some case studies of biopharmaceutical production, drawing elements of fermentation, product recovery and product characterisation in each case.