development and manufacture of protein pharmaceuticals pharmaceutical biotechnology

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Development And Manufacture Of Protein Pharmaceuticals

Author : Steve L. Nail
ISBN : 9781461505495
Genre : Medical
File Size : 69. 73 MB
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In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.

Handbook Of Pharmaceutical Biotechnology

Author : Shayne Cox Gad
ISBN : 0470117109
Genre : Medical
File Size : 33. 36 MB
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A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.

Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

Author : Feroz Jameel
ISBN : 9780470118122
Genre : Science
File Size : 35. 88 MB
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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 pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Biotechnology And Biopharmaceutical Manufacturing Processing And Preservation

Author : Kenneth E. Avis
ISBN : 1574910167
Genre : Medical
File Size : 40. 48 MB
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In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.

Rational Design Of Stable Protein Formulations

Author : John F. Carpenter
ISBN : 0306467410
Genre : Medical
File Size : 79. 11 MB
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Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.

Pharmaceutical Biotechnology

Author : Gary Walsh
ISBN : 9781118685754
Genre : Science
File Size : 71. 37 MB
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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

Methods For Structural Analysis Of Protein Pharmaceuticals

Author : Wim Jiskoot
ISBN : 0971176728
Genre : Medical
File Size : 43. 30 MB
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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.

Biotechnology And Biopharmaceuticals

Author :
ISBN : 9781118659984
Genre : Science
File Size : 32. 74 MB
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Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Formulation Characterization And Stability Of Protein Drugs

Author : Rodney Pearlman
ISBN : 9780306474521
Genre : Medical
File Size : 75. 87 MB
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Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Gibaldi S Drug Delivery Systems In Pharmaceutical Care

Author : Mary Lee
ISBN : 9781585281367
Genre : Medical
File Size : 27. 78 MB
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It is important to make therapeutics a critical component of teaching about dosage forms and to make dosage forms and drug delivery systems an integral part of therapeutics. This book will be the first to focus on the therapeutic impact of drug dosage forms.Tying together concepts of traditional pharmaceutics with therapeutics, Drug Delivery Systemsin Pharmaceutical Care demonstrates how the modern clinical pharmacist can integrate knowledge in pharmaceutical sciences and therapeutics with appreciation of patient needs and nuances to advise on preferable and optimal product choices.Each chapter represents a collaboration of a clinical pharmacist practitioner and a pharmaceutical scientist. This unique perspective takes the science of dosage form design and helps translate the theory into the pragmatic.Special Features: Case studies and problems to help students get a better understanding of concepts Well-organized chapters with outlines and objectives Summary tables and helpful figures, along with reasonable compilations of original references Final sections with 'Learning Points' that reinforce essential material. Foreword by William J. Jusko, PhD, Professor and Chair, University of Buffalo, Department of Pharmaceutical Sciences

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