Pharmaceutical Biotechnology, Second Edition
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:
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
Author 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.
