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FORMULATION AND PROCESSING Pharmaceutical Biotechnology: The Arrival of Recombinant Proteins What Is Biotechnology? Biotechnology Industry Regulatory Aspects of Biotechnology-Derived Drugs Immunogenicity of Proteins Structure-Based Drug Design Conclusions References 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 References Stability of Therapeutic Peptides and Proteins Introduction Physical Instability Chemical Instability Biosimilars and Comparability Protocols Conclusions References Preformulation and Formulation of Therapeutic Peptides and Proteins Introduction Preformulation Studies Formulation Development Pharmaceutical Excipients in Formulations Aggregation in Protein Formulations Novel Formulation Approaches Accelerated Stability Testing Quality by Design for Formulation Development Conclusions References Lyophilization, Pharmaceutical Processing, 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 References DRUG DELIVERY SYSTEMS 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 References 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 References Transdermal and Topical Delivery of Therapeutic Peptides and Proteins Introduction Approaches to Enhance Transdermal Peptide Delivery Iontophoresis Topical Delivery of Therapeutic Peptides and Proteins Conclusions References 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 References 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 References