Since the publication of the first edition of "Pharmaceutical Biotechnology" over a decade ago, a not-so-subtle shift in the meaning of the term 'biotechnology' has occurred. It has come to mean something very specific, namely the development of drug substances with large protein and polypeptide molecules. These substances can be used as drugs in their own right but may also be used to manipulate cellular DNA in order to produce a required molecule that is believed to have desirable properties in the treatment of a disease.Accordingly, the second edition of this popular text reflects that change of definition by including new material that explores the development of these protein-based therapeutic substances. See what's new in the Second Edition: expanded coverage of the formulation of proteins; additional information on proteins used as drug delivery systems; detailed discussion of interactions between proteins and phospholipids; increased information on proteomics and gene therapy; exploration of pulmonary administration and oral delivery of proteins; a broad review of vaccines; discussion of genetic engineering and genomics; and, challenges and issues involved in the development and the production of a drug.