Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Third Edition (Hardcover, 3)

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