Pharmaceutical Biotechnology, Second Edition

Pharmaceutical Biotechnology, Second Edition

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Features

  • Provides a working knowledge of the preparation, stability, and formulation of protein and peptide drugs
  • Examines the successful evolution of humanized monoclonal antibodies (MAbs) to treat rheumatoid arthritis and other diseases
  • Considers the currently disappointing results of genetic engineering and genomics that have isolated disease-responsible genes without significant clinical effect to date
  • Looks at the market and scientific reasons behind the failure of many biotechnology products to live up to their hype
  • Discusses regulatory and compendial issues and concludes with a look at future challenges facing biotechnology

Summary

Since the publication of the first edition of Pharmaceutical Biotechnology over a decade ago, a not-so-subtle shift in the meaning of the term "biotechnology" has occurred. It has come to mean something very specific, namely the development of drug substances with large protein and polypeptide molecules. These substances can be used as drugs in their own right but may also be used to manipulate cellular DNA in order to produce a required molecule that is believed to have desirable properties in the treatment of a disease. Accordingly, the second edition of this popular text reflects that change of definition by including new material that explores the development of these protein-based therapeutic substances.

See what's new in the Second Edition:

  • Expanded coverage of the formulation of proteins
  • Additional information on proteins used as drug delivery systems
  • Detailed discussion of interactions between proteins and phospholipids
  • Increased information on proteomics and gene therapy
  • Exploration of pulmonary administration and oral delivery of proteins
  • A broad review of vaccines
  • Discussion of genetic engineering and genomics
  • Challenges and issues involved in the development and the production of a drug
  • Table of Contents

    INTRODUCTION, M.J. Groves

    PROTEINS, C. P. Woodbury, Jr.
    Protein Structure
    Protein Biosynthesis
    Protein Modification
    Protein Stability
    Further Reading

    RECOMBINANT DNA BASICS, C.P. Woodbury, Jr.
    The Uses of Recombinant DNA
    Gel Electrophoresis
    Nucleic Acid Hybridization Assays
    The Polymerase Chain Reaction
    Constructing Recombinant DNA Molecules
    Engineering Protein Sequences
    Examples of Applied Recombinant DNA Technology
    Further Reading

    MONOCLONAL ANTIBODIES, D.J. Groves
    What are Monoclonal Antibodies?
    Applications of Monoclonal Antibodies
    The Generation of Monoclonal Antibodies
    Genetic Engineering
    Production Methods
    Pharmaceutical, Regulatory, and Commercial Aspects
    Further Reading and Websites

    PROTEOMICS: A NEW EMERGING AREA OF BIOTECHNOLOGY, N.O. Sahin
    Introduction
    What is a Proteome?
    Technologies for Proteomics
    Protein Identification
    Bioinformatics
    DNA and Protein Microarray Technologies
    Pharmaceutical and Medical Applications of Proteomics
    Conclusions
    References and Further Reading

    COMMONLY USED ANALYTICAL TECHNIQUES FOR BIOTECHNOLOGY PRODUCTS, W. Tang and K. Ciftci
    Analytical Tools for Proteins
    Spectroscopic and Photometric Methods
    Chromatographic Methods
    Electrophoresis
    Bioassays
    References

    FORMULATION OF PROTEINS AND PEPTIDES, M.J. Groves
    Introduction
    Making Small Protein Particles: Precipitation of Proteins from Supercritical Fluids
    Parenteral Drug Delivery Systems
    Drug Delivery through the Skin
    Multiphase Drug Delivery Systems
    Protein Compaction
    Self-Emulsifying Drug Delivery Systems
    Inclusion Compounds and Cyclodextrins as Delivery Systems
    References and Further Reading

    PROTEINS AS DRUG DELIVERY SYSTEMS, M.J. Groves
    Introduction
    Collagen
    Gelatin
    Albumin Microparticles

    PROTEINS AND PHOSPHOLIPIDS, M.J. Groves
    Introduction
    Structural Properties of Phospholipids
    Injectable Lipid Emulsions
    Formulation and Preparation
    The Physical State of Phospholipid-Stabilized Emulsions
    Peptides and Phospholipids
    Cochleal Phospholipids Structures
    References and Further Reading

    PULMONARY DRUG DELIVERY SYSTEMS FOR BIOMACROMOLECULES, C. Zamiri and R.A. Gemeinhart
    The Pulmonary Route of Drug Delivery
    Anatomy and Physiology of the Respiratory System
    Lipid-Based Pulmonary Delivery
    Solid Colloidal Particles
    Poly(dl-lactide-co-glycolide)
    Polycyanoacrylates
    Gelatin
    Poly(ether-anhydrides)
    Diketopiperazine Derivatives
    Polyethyleneimine (PEI)-DNA Complexes
    Poly(ethylene glycol) Conjugates
    Factors Affecting Pulmonary Dosing
    Conclusions
    References and Further Reading

    POLYMERIC SYSTEMS FOR ORAL PROTEIN AND PEPTIDE DELIVERY, R.A. Gemeinhart
    Introduction
    Polymers Used for Controlled Drug Delivery
    Conclusions
    References and Further Reading

    VACCINES: ANCIENT MEDICINES TO MODERN THERAPEUTICS, H.O. Alpar and M.J. Groves
    Introduction
    Requirements of an Ideal Vaccine for Today
    Types of Modern Vaccines
    Emerging Vaccine Types
    The Immune System and Mechanisms of Action
    Types of Immune Defense Mechanisms
    The Mucosal System
    Vaccine Adjuvants
    Modern Microparticulate Vaccine Vehicles
    The Future of Vaccines and Vaccination

    GENE THERAPY: AN OVERVIEW OF THE CURRENT VIRAL AND NON-VIRAL VECTORS, K. Ciftci and A. Gupte
    Introduction
    Gene Delivery Systems
    References

    REGULATORY AND COMPENDIAL ISSUES, M.J. Groves
    Introduction
    The FDA
    The United States Pharmacopeia

    SOME CHALLEGES RELATING TO THE FUTURE OF BIOPHARMACEUTICAL TECHNOLOGY, M.J. Groves
    Introduction
    Examples of Essential Biopharmaceuticals
    Other Expensive Drug Therapies
    Pharmacoeconomics and Value for Money
    Generic Biotechnological Drug Issues
    Alternatives to Protein Biologics
    Gene Engineering
    Conclusions

    Index

    Editor Bio(s)

    A pharmacist with a doctorate in chemical engineering, Dr. Groves has spent much of his career working in industry and academe. Now retired, his scientific interests include dispersed drug delivery systems and quality control issues for parenteral drug products. Editor or joint editor of a number of books, he has published 400 research papers, patents, reviews and book reviews. He is a Fellow of the Royal Pharmaceutical Society of Great Britain, the Institute of Biology and the American Association of Pharmaceutical Scientists.

     
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