1. Overview of protein formulation and delivery / James Wright -- 2. Chemical considerations in protein and peptide stability / Paul M. Bummer -- 3. Physical considerations in protein and peptide stability / Sandy Koppenol -- 4. Analytical methods and stability testing of biopharmaceuticals / Helmut Hoffmann and Sandra Pisch-Heberle -- 5. Preformulation development of protein drugs / Frank K. Bedu-Addo -- 6. Solution formulation of proteins/peptides / Paul McGoff and David S. Scher -- 7. Formulation of leuprolide at high concentration for delivery from a one-year duration implant / Cynthia L. Stevenson -- 8. Freeze-drying concepts : the basics / Larry A. Gatlin ... [et al.] -- 9. Rational choice of excipients for use in lyophilized formulations / Evgenyi Y. Shalaev, Wei Wang, and Larry A. Gatlin -- 10. Formulation of proteins for pulmonary delivery / Andrew R. Clark, Cynthia L. Stevenson, and Steven J. Shire -- 11. Using needle-free injectors for parenteral delivery of proteins / Stephen J. Farr ... [et al.] -- 12. Oral delivery of biopharmaceuticals using the Eligen technology / Ehud Arbit, Shingai Majuru, and Isabel Gomez-Orellana -- 13. Setting specifications and expiration dating for biotechnology products / Carol Hasselbacher, Wassim Nashabeh, and Anthony Mire-Sluis -- 14. Development of drug products : similarities and differences between protein biologics and small synthetic molecules / Eugene J. McNally and Jayne E. Hastedt.