Search results for ""Author Gary Walsh""

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

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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. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

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Proteins Biochemistry and Biotechnology 2e is a definitive source of information for all those interested in protein science, and particularly the commercial production and isolation of specific proteins, and their subsequent utilization for applied purposes in industry and medicine. Fully updated throughout with new or fundamentally revised sections on proteomics as, bioinformatics, protein glycosylation and engineering, well as sections detailing advances in upstream processing and newer protein applications such as enzyme-based biofuel production this new edition has an increased focus on biochemistry to ensure the balance between biochemisty and biotechnology, enhanced with numerous case studies. This second edition is an invaluable text for undergraduates of biochemistry and biotechnology but will also be relevant to students of microbiology, molecular biology, bioinformatics and any branch of the biomedical sciences who require a broad overview of the various medical, diagnostic and industrial uses of proteins. • Provides a comprehensive overview of all aspects of protein biochemisty and protein biotechnology • Includes numerous case studies • Increased focus on protein biochemistry to ensure balance between biochemisty and biotechnology • Includes new section focusing on proteomics as well as sections detailing protein function and enzyme-based biofuel production "With the potential of a standard reference source on the topic, any molecular biotechnologist will profit greatly from having this excellent book. " (Engineering in Life Sciences, 2004; Vol 5; No. 5) “Few texts would be considered competitors, and none compare favorably." (Biochemistry and Molecular Education, July/August 2002) "...The book is well written, making it informative and easy to read..." (The Biochemist, June 2002)

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Proteins Biochemistry and Biotechnology 2e is a definitive source of information for all those interested in protein science, and particularly the commercial production and isolation of specific proteins, and their subsequent utilization for applied purposes in industry and medicine. Fully updated throughout with new or fundamentally revised sections on proteomics as, bioinformatics, protein glycosylation and engineering, well as sections detailing advances in upstream processing and newer protein applications such as enzyme-based biofuel production this new edition has an increased focus on biochemistry to ensure the balance between biochemisty and biotechnology, enhanced with numerous case studies. This second edition is an invaluable text for undergraduates of biochemistry and biotechnology but will also be relevant to students of microbiology, molecular biology, bioinformatics and any branch of the biomedical sciences who require a broad overview of the various medical, diagnostic and industrial uses of proteins. • Provides a comprehensive overview of all aspects of protein biochemisty and protein biotechnology • Includes numerous case studies • Increased focus on protein biochemistry to ensure balance between biochemisty and biotechnology • Includes new section focusing on proteomics as well as sections detailing protein function and enzyme-based biofuel production "With the potential of a standard reference source on the topic, any molecular biotechnologist will profit greatly from having this excellent book. " (Engineering in Life Sciences, 2004; Vol 5; No. 5) “Few texts would be considered competitors, and none compare favorably." (Biochemistry and Molecular Education, July/August 2002) "...The book is well written, making it informative and easy to read..." (The Biochemist, June 2002)

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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. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

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Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy. Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume.This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference.

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Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine. Written mainly by industry experts, the book includes information sourced directly from the company that developed or manufactured the product. It explores major development issues, from manufacturing and marketing to delivery of the finished product.Chapter 1 reviews applied enzymology while chapter 2 delineates theory and applications. Between them, the first two chapters set the appropriate backdrop for the remaining chapters, which focus on actual enzyme products that have gained regulatory approval for general medical use. The chapter authors discuss the biochemistry of the enzymes, the reactions they catalyze, how they are produced or manufactured, and their medical applications. The book highlights the many applications of approved therapeutic enzymes, including use in the treatment of blood-clotting disorders, certain cancers, and a variety of genetic disorders. Illustrated with tables and figures that support the text, the book is a single source of in-depth technical information.

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Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

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