An Essential Guide to Biopharmaceuticals

An Essential Guide to Biopharmaceuticals PDF Author: David Aebisher
Publisher: Nova Science Publishers
ISBN: 9781536181784
Category : Medicinal plants
Languages : en
Pages : 218

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Book Description
This book provides a current review of the field of biopharmaceutical pharmacology. Biopharmaceuticals are drugs obtained in biotechnological processes using living organisms such as bacteria and fungi. An analysis was performed from biochemical and physiological point of view. This book covers an essential guide to current knowledge and analysis of biopharmaceuticals (Chapter 1-5). The composition of the biopharmaceuticals is provided. In this book we also discuss the historical point of view of the use of archeological botany, medicinal plants, strategies and main advances in communication between the nature and the advances of biopharmacy (Chapter 6-8). This book reports results from experimental and clinical work (Chapter 9). The book includes data regarding the therapy in combination with chemotherapeutic agents.

An Essential Guide to Biopharmaceuticals

An Essential Guide to Biopharmaceuticals PDF Author: David Aebisher
Publisher: Nova Science Publishers
ISBN: 9781536181784
Category : Medicinal plants
Languages : en
Pages : 218

Get Book Here

Book Description
This book provides a current review of the field of biopharmaceutical pharmacology. Biopharmaceuticals are drugs obtained in biotechnological processes using living organisms such as bacteria and fungi. An analysis was performed from biochemical and physiological point of view. This book covers an essential guide to current knowledge and analysis of biopharmaceuticals (Chapter 1-5). The composition of the biopharmaceuticals is provided. In this book we also discuss the historical point of view of the use of archeological botany, medicinal plants, strategies and main advances in communication between the nature and the advances of biopharmacy (Chapter 6-8). This book reports results from experimental and clinical work (Chapter 9). The book includes data regarding the therapy in combination with chemotherapeutic agents.

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals PDF Author:
Publisher: John Wiley & Sons
ISBN: 1118659988
Category : Science
Languages : en
Pages : 744

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Book Description
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 and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals PDF Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470595876
Category : Science
Languages : en
Pages : 986

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Book Description
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.

Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts

Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts PDF Author: Claire Komives
Publisher: John Wiley & Sons
ISBN: 1118361989
Category : Science
Languages : en
Pages : 288

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Book Description
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing PDF Author: Hamid Mollah
Publisher: John Wiley & Sons
ISBN: 0470552344
Category : Science
Languages : en
Pages : 432

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Book Description
Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Understanding Pharma

Understanding Pharma PDF Author: John J. Campbell
Publisher: Pharmaceutical Press
ISBN: 9780976309635
Category : Pharmaceutical industry
Languages : en
Pages : 311

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Book Description


Clinical Trials of Drugs and Biopharmaceuticals

Clinical Trials of Drugs and Biopharmaceuticals PDF Author: Chi-Jen Lee
Publisher: CRC Press
ISBN: 1420039148
Category : Medical
Languages : en
Pages : 520

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Book Description
The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an

Development and Manufacture of Protein Pharmaceuticals

Development and Manufacture of Protein Pharmaceuticals PDF Author: Steve L. Nail
Publisher: Springer Science & Business Media
ISBN: 1461505496
Category : Medical
Languages : en
Pages : 479

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Book Description
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.

Drug Discovery and Development - E-Book

Drug Discovery and Development - E-Book PDF Author: Raymond G Hill
Publisher: Elsevier Health Sciences
ISBN: 0702053163
Category : Medical
Languages : en
Pages : 361

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Book Description
The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries' trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. - The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ● non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ● Visiting Industrial Professor of Pharmacology in the University of Bristol ● Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ● Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ● President and Chair of the Council of the British Pharmacological Society ● member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: - Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. - New topic - DMPK Optimization Strategy in drug discovery. - New chapter on Scaffolds: Small globular proteins as antibody substitutes. - Totally updated chapters on Intellectual Property and Marketing - 50 new illustrations in full colour Features - Accessible, general guide to pharmaceutical research and development. - Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. - Written by a strong team of scientists with long experience in the pharmaceutical industry. - Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: '... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. - Highly Commended in the medicine category of the BMA 2006 medical book competition - Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year

Applied Biopharmaceutics and Pharmacokinetics

Applied Biopharmaceutics and Pharmacokinetics PDF Author: Leon Shargel
Publisher: McGraw-Hill/Appleton & Lange
ISBN: 9780838502396
Category : Biopharmaceutics
Languages : en
Pages : 625

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Book Description