Therapeutic Peptides and Proteins provides an understanding of protein formulation and delivery from the ground up.

Features:

• Includes information on FDA regulatory activities in peptide- and protein-based drug research, approval, and manufacturing
• Explores peptide- and protein-based vaccines and therapeutic agents
• Contains hard to find practical information on protein formulation
• Discusses recent developments such as well-characterized biologicals, statistical design for protein preformulation, and process analytical technologies
• Covers new developments in delivery systems, including a discussion of skin microporation and pulmonary delivery

Contents

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

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

Stability of Therapeutic Peptides and Proteins

• Physical Instability
• Chemical instability
• Well-Characterized Products and Comparability Protocols

Preformulation and Formulations of Therapeutic Peptides and Proteins

• Preformulation Studies
• Formulation Development
• Pharmaceutical Excipients in Formulations
• Aggregation in Protein Formulations
• Novel Formulation Approaches
• Accelerated Stability Testing
• Statistical Design for Formulation Development

Lyophilization, Pharmaceutical Processing, and Handling of Therapeutic Peptides and Protiens

• Protein Destabilization Induced by Pharmaceutical Processing
• Lyophilization as a Pharmaceutical Process
• Alternative Pharmaceutical Processes
• Handling of Therapeutic Peptides and Proteins

Parenteral Controlled Delivery and Pharmacokinetics of Therapeutic Peptides and Proteins

• 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

Oral Delivery of Peptide and Protien Drugs

• Barriers to Protein Absorption and Pathways of Penetration
• Approaches to Improve Oral Delivery
• Methods to Study Oral Absorption
• Oral Immunization

Transdermal and Topical Delivery of Therapeutic Peptides and Proteins

• Skin Structure
• Approaches to Enhance Transdermal Peptide Delivery
• Iontophoresis
• Topical Delivery of Therapeutic Peptides and Proteins

Pulmonary and Other Mucosal Delivery of Therapeutic Peptides and Proteins

• Pulmonary Delivery
• Nasal Delivery
• Rectal Delivery
• Buccal Delivery
• Ocular Delivery
• Comparative Evaluation of Mucosal Routes

Recombinant Protein Subunit Vaccines and Delivery Methods

• Immunology Relevant to Vaccines
• Routes of Administration
• Delivery Approaches for Administration of Vaccines
• Case example: Hepatitis B

Index

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