The units in this module were selected to give the 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 principles of Good Maunfacturing Practice are discussed in the third unit, which is relevant to all aspects of drug manufacturing, including fermentation and product recovery operations. This unit is thus designed to put regulatory principles in the context of biopharmaceutical manufacture. The last unit covers modern methods of product characterisation, which forms a critical component of the regulatory procedure.