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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.
Author: Steve L. Nail
Publisher: Springer Science & Business Media
ISBN: 1461505496
Category : Medical
Languages : en
Pages : 479
Get Book Here
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.
Author: Wim Jiskoot
Publisher: Springer Science & Business Media
ISBN: 9780971176720
Category : Medical
Languages : en
Pages : 694
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Book Description
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.
Author: Hanns-Christian Mahler
Publisher: John Wiley & Sons
ISBN: 1118150562
Category : Medical
Languages : en
Pages : 480
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Book Description
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.
Author: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 0306474522
Category : Medical
Languages : en
Pages : 455
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Book Description
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.
Author: Tristan Vaughan
Publisher: John Wiley & Sons
ISBN: 3527340866
Category : Medical
Languages : en
Pages : 762
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Book Description
Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche.
Author: Carlos A. Guzmán
Publisher: Springer
ISBN: 9781461429241
Category : Medical
Languages : en
Pages : 276
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Book Description
Pharmaceutical Biotechnology is a unique compilation of reviews addressing frontiers in biologicals as a rich source for innovative medicines. This book fulfills the needs of a broad community of scientists interested in biologicals from diverse perspectives—basic research, biotechnology, protein engineering, protein delivery, medicines, pharmaceuticals and vaccinology. The diverse topics range from advanced biotechnologies aimed to introduce novel, potent engineered vaccines of unprecedented efficacy and safety for a wide scope of human diseases to natural products, small peptides and polypeptides engineered for discrete prophylaxis and therapeutic purposes. Modern biologicals promise to dramatically expand the scope of preventive medicine beyond the infectious disease arena into broad applications in immune and cancer treatment, as exemplified by anti-EGFR receptors antibodies for the treatment of breast cancer. The exponential growth in biologicals such as engineered proteins and vaccines has been boosted by unprecedented scientific breakthroughs made in the past decades culminating in an in-depth fundamental understanding of the scientific underpinnings of immune mechanisms together with knowledge of protein and peptide scaffolds that can be deliberately manipulated. This has in turn led to new strategies and processes. Deciphering the human, mammalian and numerous pathogens’ genomes provides opportunities that never before have been available—identification of discrete antigens (genomes and antigenomes) that lend themselves to considerably improved antigens and monoclonal antibodies, which with more sophisticated engineered adjuvants and agonists of pattern recognition receptors present in immune cells, deliver unprecedented safety and efficacy. Technological development such a nanobiotechnologies (dendrimers, nanobodies and fullerenes), biological particles (viral-like particles and bacterial ghosts) and innovative vectors (replication-competent attenuated, replication-incompetent recombinant and defective helper-dependent vectors) fulfill a broad range of cutting-edge research, drug discovery and delivery applications. Most recent examples of breakthrough biologicals include the human papilloma virus vaccine (HPV, prevention of women genital cancer) and the multivalent Pneumoccocal vaccines, which has virtually eradicated in some populations a most prevalent bacterial ear infection (i.e., otitis media). It is expected that in the years to come similar success will be obtained in the development of vaccines for diseases which still represent major threats for human health, such as AIDS, as well as for the generation of improved vaccines against diseases like pandemic flu for which vaccines are currently available. Furthermore, advances in comparative immunology and innate immunity revealed opportunities for innovative strategies for ever smaller biologicals and vaccines derived from species such as llama and sharks, which carry tremendous potential for innovative biologicals already in development stages in many pharmaceutical companies. Such recent discoveries and knowledge exploitations hold the promise for breakthrough biologicals, with the coming decade. Finally, this book caters to individuals not directly engaged in the pharmaceutical drug discovery process via a chapter outlining discovery, preclinical development, clinical development and translational medicine issues that are critical the drug development process. The authors and editors hope that this compilation of reviews will help readers rapidly and completely update knowledge and understanding of the frontiers in pharmaceutical biotechnologies.
Author: Maria Hayes
Publisher: John Wiley & Sons
ISBN: 111938530X
Category : Science
Languages : en
Pages : 352
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Book Description
A groundbreaking text that highlights the various sources, applications and advancements concerning proteins from novel and traditional sources Novel Proteins for Food, Pharmaceuticals and Agriculture offers a guide to the various sources, applications, and advancements that exist and are currently being researched concerning proteins from novel and traditional sources. The contributors—noted experts in the field—discuss sustainable protein resources and include illustrative examples of bioactive compounds isolated from several resources that have or could obtain high market value in specific markets. The text also explores a wide range of topics such as functional food formulations and pharmaceutical applications, and how they alter biological activity to provide therapeutic benefits, nutritional values and health protection. The authors also examine the techno-functional applications of proteins and looks at the screening process for identification of bioactive molecules derived from protein sources. In addition, the text provides insight into the market opportunities that exist for novel proteins such as insect, by-product derived, macroalgal and others. The authors also discuss the identification and commercialization of new proteins for various markets. This vital text: Puts the focus on the various sources, applications and advancements concerning proteins from novel and traditional sources Contains a discussion on how processing technologies currently applied to dairy could be applied to novel protein sources such as insect and macroalgal Reviews the sustainability of protein sources and restrictions that exist concerning development Offers ideas for creating an innovative and enterprising economy that is built on recent developments Details the potential to exploit key market opportunities in sports, infant and elderly nutrition and techno-functional protein applications Written for industrial researchers as well as PhD and Post-doctoral researchers, and undergraduate students studying biochemistry, food engineering and biological sciences and those interested in market developments, Novel Proteins for Food, Pharmaceuticals and Agriculture offers an essential guide to the sources, applications and most recent developments of the proteins from both innovative and traditional sources.
Author: P. Buckel
Publisher: Springer Science & Business Media
ISBN: 9783764359041
Category : Medical
Languages : en
Pages : 226
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Book Description
Recombinant protein drugs are intimately associated with the impressive success story of the Biotech Industry during the past thirty years, some of them belonging to the most successful pharmaceutical products. More than thirty different proteins are available for a variety of clinical applications, over 300 proteins are presently being evaluated in clinical trials. In this new volume of the MDT series, historical, technical and clinical aspects of recombinant protein drug discovery and development are presented, covering past, present and future highlights. Leading scientists and co-founders of early Biotech companies describe technical breakthroughs and the fascinating story of pioneering discoveries, as well as the long way of translating them into products and business. Therefore, this book represents an exciting documentation of the beginning of a new era in the pharmaceutical industry. In addition, scientists from basic research, clinic and industry actively involved in new developments discuss...
Author: James N. Herron
Publisher: Springer Science & Business Media
ISBN: 1489910794
Category : Medical
Languages : en
Pages : 374
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Book Description
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 have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs.
Author: Stefan Behme
Publisher: John Wiley & Sons
ISBN: 3527349472
Category : Science
Languages : en
Pages : 422
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Book Description
An expert, single-volume overview of the core processes and disciplines of biopharmaceutical production In the newly revised Third Edition of Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control. Suitable as both a reference book and a training resource, this book extensively explores the impact of digital transformation on pharmaceutical protein manufacturers and includes a brand-new chapter dedicated to digitalization. The distinguished author provides readers with practical understanding of the terminology and principles driving the various fields involved with biotechnological production, including operations, legal, finance, and IT. He also offers: A thorough introduction to biopharmaceutical production, including value creation, product types, and biological basics Comprehensive explorations of the technology of the manufacturing process and analytics Practical discussions of pharmacology and drug safety, quality assurance, and pharmaceutical law In-depth examinations of pharmaceutical protein production facilities, including facility design and the planning, construction, and commissioning of a manufacturing plant Perfect for biotechnologists working in the pharmaceutical industry, Manufacturing of Pharmaceutical Proteins: From Technology to Economy will also earn a place in the libraries of pharmaceutical engineers seeking a one-stop reference for all aspects of biopharmaceutical production.
