Pharmaceutical Biotechnology: The Arrival of Recombinant Proteins; What is Biotechnology; The Biotechnology Industry; Regulatory Aspects of Biotechnology-Derived Drugs; Immunogenicity of Proteins; Structure-Based Drug Design; Conclusions; Structure and Analysis of Therapeutic Peptides and Proteins; Amino Acids: Building Blocks of Proteins; Structure of Peptides and Proteins; Protein Conformation and Other Structural Features; Analytical Methods; Conclusions; Stability of Therapeutic Peptides and Proteins; Introduction; Physical Instability; Chemical instability; Well-Characterized Products and Comparability Protocols; Conclusions; Preformulation and Formulation of Therapeutic Peptides and Proteins; Introduction; Preformulation Studies; Formulation Development; Pharmaceutical Excipients in Formulations; Aggregation in Protein Formulations; Novel Formulation Approaches
And Handling of Therapeutic Peptides and Proteins; Introduction; Protein Destabilization Induced by Pharmaceutical Processing; Lyophilization as a Pharmaceutical Process; Alternative Pharmaceutical Processes; Handling of Therapeutic Peptides and Proteins; Conclusions; Parenteral Controlled Delivery and Pharmacokinetics of Therapeutic Peptides and Proteins; Introduction; Pharmacokinetics of Peptide and Protein Drugs; Polymers Used for Controlled Delivery of Peptides and Proteins; Parenteral Controlled Release Systems; Innovations in Parenteral Administration of Proteins; Examples of Protein Pharmacokinetics; Conclusions; Oral Delivery of Peptide and Protein Drugs; Introduction; Barriers to Protein Absorption and Pathways of Penetration; Approaches to Improve Oral Delivery; Methods to Study Oral Absorption; Oral Immunization; Conclusions; Transdermal and Topical Delivery of Therapeutic
Peptides and Proteins; Introduction; Skin Structure; Approaches to Enhance Transdermal Peptide Delivery; Iontophoresis; Topical Delivery of Therapeutic Peptides and Proteins; Conclusions; Pulmonary and Other Mucosal Delivery of Therapeutic Peptides and Proteins; Introduction; Pulmonary Delivery; Nasal Delivery; Rectal Delivery; Buccal Delivery; Ocular Delivery; Comparative Evaluation of Mucosal Routes; Conclusions; Recombinant Protein Subunit Vaccines and Delivery Methods; Introduction; Immunology Relevant to Vaccines; Routes of Administration; Delivery Approaches for Administration of Vaccines; Case example: Hepatitis B; Future Outlook and Regulatory Status; Conclusions
