New Vaccine Development: Establishing Priorities

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Enzyme Technologies for Pharmaceutical and Biotechnological Applications

A review of enzyme function in human and animal health, this book covers basic principles and applications in antibiotic biosynthesis, biocatalysis, and screening and assay optimization, as well as new and emerging technologies in the biotechnological and pharmaceutical industries.It offers real-world examples of timely laboratory, pharmaceutical and manufacturing processes, including large-scale applications of enzyme manipulations.

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Technology Transfer in Biotechnology: From Lab to Industry to Production

Several new methods besides the usual organic solvent extraction have been developed over the last few years for the extraction of primary and secondary metabolites. These are: alcohol extraction with various biocompatible solvents, recovery of carboxylic acids and antibiotics with reactive extraction, dissociation extraction, aqueous two-phase extraction, and supercritical and near critical fluid extraction.Extraction and re-extraction processes are integrated into a single step by emulsion liquid membrane and solid supported liquid membrane extractions. These extraction processes are discussed and compared in this review, along with extraction with reversed micelles, and reactive extraction with the formation of a third phase at the organic-aqueous interface.

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Recombinant Antibodies for Immunotherapy

Melvyn Little PhD, "Recombinant Antibodies for Immunotherapy"
Cambridge University Press 2009 ISBN: 0521887321 440 pages PDF 3,8 MB

Recombinant Antibodies for Immunotherapy provides a comprehensive overview of the field of monoclonal antibodies (mAbs), a market that has grown tremendously in recent years. Twenty-five articles by experienced and innovative authors cover the isolation of specific human mAbs, humanization, immunogenicity, technologies for improving efficacy, "arming" mAbs, novel alternative Ab constructs, increasing half-lives, alternative concepts employing non-immunoglobulin scaffolds, novel therapeutic approaches, a market analysis of therapeutic mAbs, and future developments in the field. The concepts and technologies are illustrated by examples of recombinant antibodies being used in the clinic or in development. This book will appeal to both newcomers and experienced scientists in the field, biology and biotechnology students, research and development departments in the pharmaceutical industry, medical researchers, clinicians, and biotechnology investors.

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Pharmaceutical Biotechnology: Concepts and Applications

Pharmaceutical Biotechnology: Concepts and Applications
ISBN: 0470012447 | edition 2007 | File type: PDF | 499 pages | 10,1 mb

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. 

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Clean-in-Place for Biopharmaceutical Processes

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.

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Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics: Homogeneous and Heterogeneous Approaches

The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with empirical, compartmental, and stochastic pharmacokinetic models, and the fourth mainly with nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. Many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.

This timely and useful book will appeal to graduate students and researchers in pharmacology, pharmaceutical sciences, bioengineering, and physiology.

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Drug Absorption Studies: In Situ, In Vitro and In Silico Models

In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models offer a fast, convenient approach with cost advantages most of times. Most importantly, they can be standardised and automatised to be applicable to the high-throughput screening.

Starting at the molecular level of studies, continuing with cell monolayer models (both primary and cell lines) and in situ techniques as a final testing format, the book provides a practical approach to contemporary in vitro techniques for drug absorption studies. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix comprised with a number of practical protocols is available online, updated as needed, should prove very helpful to apply the techniques directly to the benchside.

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Environmental Monitoring for Cleanrooms and Controlled Environments

A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient.

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Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition

Thoroughly acquainting the reader with freeze-drying fundamentals-including water properties critical to the process and mechanisms and means of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures-ensuring the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation.

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