Pharmaceutical Biotechnology explores the development of protein-based therapeutic substances.

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

Contents

Proteins

• Protein Structure
• Protein Biosynthesis
• Protein Modification
• Protein Stability

Recombinant DNA Basics

• 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

Monoclonal Antibodies

• What are Monoclonal Antibodies?
• Applications of Monoclonal Antibodies
• The Generation of Monoclonal Antibodies
• Genetic Engineering
• Production Methods
• Pharmaceutical, Regulatory, and Commercial Aspects

Proteomics: A New Emerging Area of Biotechnology

• What is a Proteome
• Technologies for Proteomics
• Protein Identification
• Bioinformatics
• DNA and Protein Microarray Technologies
• Pharmaceutical and Medical Applications of Proteomics

Commonly Used Analytical Techniques for Biotechnology Products

• Analytical Tools for Proteins
• Spectroscopic and Photometric Methods
• Chromatographic Methods
• Electrophoresis
• Bioassays

Formulation of Proteins and Peptides

• 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

Proteins as Drug Delivery Systems

• Collagen
• Gelatin
• Albumin Microparticles

Proteins and Phospholipids

• Structural Properties of Phospholipids
• Injectable Lipid Emulsions
• Formulation and Preparation
• The Physical State of Phospholipid-Stabilized Emulsions
• Peptides and Phospholipids
• Cochleal Phospholipids Structures

Pulmonary Drug Delivery Systems for Biomacromolecules

• 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

Polymeric Systems for Oral Proten and Peptide Delivery

• Polymers Used for Controlled Drug Delivery

Vaccines: Ancient Medicines to Modern Therapeutics

• 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 Current Viral and Non-Viral Vectors

• Gene Delivery Systems

Regulatory and Compendial Issues

• The FDA
• The United States Pharmacopeia

Some Challenges Relating to the Future of Biopharmaceutical Technology

• Examples of Essential Biopharmaceuticals
• Other Expensive Drug Therapies
• Pharmacoeconomics and Value for Money
• Generic Biotechnological Drug Issues
• Alternatives to Protein Biologics
• Gene Engineering

Index

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