Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Second Edition

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ISBN 9780849316302
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Features

  • Provides an understanding of protein formulation and delivery from the ground up
  • 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
  • Summary

    Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up-to-date, relevant information on protein formulation and/or delivery systems and the need for a new edition is self-evident. This second edition continues the tradition of providing a ready-to-use reference of accurate information, tables, and illustrations.

    The book begins with the basics of the origin of recombinant proteins, explores structural and analytical aspects, and moves on to discuss the stability of proteins and peptides. Against this background, the author addresses preformulation and formulation considerations and provides detailed information on important topics such as lyophilization. He goes on to discuss various delivery systems, including controlled release delivery systems and products currently on the market. The book also contains newly added regulatory information and thoroughly investigates therapeutic drugs made from proteins as well as protein-based vaccines. A new chapter on recombinant protein subunit vaccines and their delivery systems has been added.

    The work of a single author, the book provides complex information in a simple, elegant, and cohesive style. The author minimizes overlap between coverage and includes extensive cross-referencing that links related topics. Completely revised and updated, packed with cutting-edge information, the second edition once again fills the need for a reference that pulls all the relevant information together into one resource.

    Table of 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
    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
    Accelerated Stability Testing
    Statistical Design for Formulation Development
    Conclusions
    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
    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

    Editorial Reviews

    “The book begins with the basics of the origin for recombinant proteins, explores structural and analytical aspects, and moves on to discuss the stability of proteins and peptides. … The book also contains newly added regulatory information and thoroughly investigates therapeutic drugs made form proteins as well as protein-based vaccines. A new chapter on recombinant protein subunit vaccines and their delivery systems has been added. … the book provides complex information in a simple, elegant, uniform style. … includes extensive cross-referencing that directs the reader to relevant parts of the book for related topics. Completely revised and updated, the second edition once again fills the need for a reference that pulls all the relevant information together into one resource.”
    — In Anticancer Research, Vol. 26, 2006