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Author: Lars Hovgaard
Publisher: CRC Press
ISBN: 1439853894
Category : Medical
Languages : en
Pages : 392
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Book Description
The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therap
Author: Lars Hovgaard
Publisher: CRC Press
ISBN: 1439853894
Category : Medical
Languages : en
Pages : 392
Get Book Here
Book Description
The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therap
Author: Lars Hovgaard
Publisher: CRC Press
ISBN: 9781135737702
Category : Medical
Languages : en
Pages : 238
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Book Description
Pharmaceutical formulation of peptides and proteins has become an important part of modern drug development. Many new drugs are based on peptide or protein recombinant technology going hand in hand with more traditional pharmaceutical formulation. In order to develop products with optimal characters, it is important to give scientists interdisciplinary knowledge and a thorough understanding of the complex nature of pharmaceutical formulation of peptides and proteins. This comprehensive volume brings the different aspects of peptide and protein formulation into focus, beginning with the fundamentals of the production of peptides and proteins, ranging from peptide synthesis and recombinant DNA technology to protein purification. It discusses the characterization and chemical stability of peptides and proteins, before moving on to formulation, detailing peptides and proteins in solution and as suspensions, as well as lyophilized peptide and protein products. There follows a case study on drug delivery systems for alternative routes of administration. Finally, regulatory aspects are discussed in terms of chemical and pharmaceutical documentation. Each chapter is written by experts in their respective areas. Scientists in the industry and academia, and postgraduate students in pharmaceutical science will find this a valuable resource, which can be dipped in to as a reference, or studied as a whole.
Author: Eugene J. McNally
Publisher: CRC Press
ISBN: 0849379520
Category : Medical
Languages : en
Pages : 372
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Book Description
This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytica
Author: Ajay K. Banga
Publisher: CRC Press
ISBN: 1420039830
Category : Medical
Languages : en
Pages : 375
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Book Description
Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up
Author: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 1489912363
Category : Medical
Languages : en
Pages : 371
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Book Description
This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing. The editors have selected a wide range of molecules derived from monoclonal antibodies, recombinant DNA, and natural and chemical sources to provide formulation scientists with practical examples of the development of pharmaceutical products.
Author: Ajay K. Banga
Publisher: CRC Press
ISBN: 1466566078
Category : Medical
Languages : en
Pages : 396
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Book Description
There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis. The c
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: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 9780306453328
Category : Medical
Languages : en
Pages : 470
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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:
Publisher:
ISBN: 9781566763851
Category : Peptides
Languages : en
Pages :
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Book Description
Author: John F. Carpenter
Publisher: Springer Science & Business Media
ISBN: 1461505577
Category : Medical
Languages : en
Pages : 218
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Book Description
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.
