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Methods for Structural Analysis of Protein Pharmaceuticals
Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. This book explores the nature of different analytical techniques and the way in which they are related to pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time.
Analysis of Aggregates and Particles in Protein Pharmaceuticals
This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.
Physical Methods to Characterize Pharmaceutical Proteins
Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration ha...
Pharmaceutical Biotechnology
This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fifth Edition completely updates the previous edition, and also includes additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech and enzyme replacement therapy.
Nanostructured Biomaterials for Overcoming Biological Barriers
Overcoming biological barriers is of importance for solving the problems of many current drugs and vaccines, and is especially relevant in the commerical exploitation of new therapeutic strategies. This book focuses on the mechanistic issues related to the interaction between drug delivery systems and biological barriers.
Meningococcal Vaccines
Since the first recognition of outbreaks of cerebrospinal or spotted fever at the end of the nineteenth and the beginning of the twentieth centuries, the menace of the meningococcus has been high on the list of public health prio- ties. Few if any pathogens surpass the meningococcus in the rapidity and sev- ity with which it devastates previously healthy individuals. The challenge of understanding the biology of this fascinating microbe is immense, but few will doubt that successful control of meningococcal meningitis and septicemia will only transpire through the application of a body of extraordinary detailed inf- mation, including key minutiae of its molecular biology. In the first of two companion volumes, Meningococcal Vaccines, the team of experts gathered by Andy Pollard and Martin Maiden converge to p- vide an impressive accumulation of molecular tools with which to lay bare the secrets of the meningococcus. The results of this ambitious and welcome v- ume represent an exciting and much needed resource for all of us in the field.
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pa...
Principles of Immunopharmacology
The rapid developments in immunology in recent immunomodulatory drugs can be distinguished years have dramatically expanded our knowledge of from their beneficial therapeutic effects. mammalian host defence mechanisms. The molecu- Currently,it is only possible to obtain an overview lar mechanisms of cellular interactions during of these various aspects of immunopharmacology immune responses have been unravelled,the intra- by reading a range of immunological,pharmacol- cellular responses involved in signal transduction ical,diagnostic and toxicological literature. Good delineated and an ever-increasing number of soluble immunological textbooks are available, while mediators of immune and infl...
Challenges in Protein Product Development
In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufac...
