Physical Methods To Characterize Pharmaceutical Proteins

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Physical Methods to Characterize Pharmaceutical Proteins

Author : James N. Herron,Wim Jiskoot,Daan J.A. Crommelin
Publisher : Springer Science & Business Media
Page : 374 pages
File Size : 43,5 Mb
Release : 2013-11-21
Category : Medical
ISBN : 9781489910790

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Physical Methods to Characterize Pharmaceutical Proteins by James N. Herron,Wim Jiskoot,Daan J.A. Crommelin Pdf

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.

Stability and Characterization of Protein and Peptide Drugs

Author : Rodney Pearlman,Y. John Wang
Publisher : Springer Science & Business Media
Page : 371 pages
File Size : 42,5 Mb
Release : 2013-06-29
Category : Medical
ISBN : 9781489912367

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Stability and Characterization of Protein and Peptide Drugs by Rodney Pearlman,Y. John Wang Pdf

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.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author : Damian J. Houde,Steven A. Berkowitz
Publisher : Elsevier
Page : 586 pages
File Size : 43,7 Mb
Release : 2019-11-13
Category : Medical
ISBN : 9780444641748

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals by Damian J. Houde,Steven A. Berkowitz Pdf

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Analysis of Aggregates and Particles in Protein Pharmaceuticals

Author : Hanns-Christian Mahler,Wim Jiskoot
Publisher : John Wiley & Sons
Page : 480 pages
File Size : 48,9 Mb
Release : 2012-01-24
Category : Medical
ISBN : 9780470497180

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Analysis of Aggregates and Particles in Protein Pharmaceuticals by Hanns-Christian Mahler,Wim Jiskoot Pdf

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.

Protein and Peptide Mass Spectrometry in Drug Discovery

Author : Michael L. Gross,Guodong Chen,Birendra Pramanik
Publisher : John Wiley & Sons
Page : 484 pages
File Size : 52,8 Mb
Release : 2011-09-26
Category : Medical
ISBN : 9781118116548

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Protein and Peptide Mass Spectrometry in Drug Discovery by Michael L. Gross,Guodong Chen,Birendra Pramanik Pdf

The book that highlights mass spectrometry and its application in characterizing proteins and peptides in drug discovery An instrumental analytical method for quantifying the mass and characterization of various samples from small molecules to large proteins, mass spectrometry (MS) has become one of the most widely used techniques for studying proteins and peptides over the last decade. Bringing together the work of experts in academia and industry, Protein and Peptide Mass Spectrometry in Drug Discovery highlights current analytical approaches, industry practices, and modern strategies for the characterization of both peptides and proteins in drug discovery. Illustrating the critical role MS technology plays in characterizing target proteins and protein products, the methods used, ion mobility, and the use of microwave radiation to speed proteolysis, the book also covers important emerging applications for neuroproteomics and antigenic peptides. Placing an emphasis on the pharmaceutical industry, the book stresses practice and applications, presenting real-world examples covering the most recent advances in mass spectrometry, and providing an invaluable resource for pharmaceutical scientists in industry and academia, analytical and bioanalytical chemists, and researchers in protein science and proteomics.

Formulation, Characterization, and Stability of Protein Drugs

Author : Rodney Pearlman,Y. John Wang
Publisher : Springer Science & Business Media
Page : 432 pages
File Size : 53,9 Mb
Release : 2006-04-11
Category : Medical
ISBN : 9780306474521

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Formulation, Characterization, and Stability of Protein Drugs by Rodney Pearlman,Y. John Wang Pdf

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.

Methods for Structural Analysis of Protein Pharmaceuticals

Author : Wim Jiskoot,Daan Crommelin
Publisher : Springer Science & Business Media
Page : 694 pages
File Size : 42,6 Mb
Release : 2005-12-05
Category : Medical
ISBN : 0971176728

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Methods for Structural Analysis of Protein Pharmaceuticals by Wim Jiskoot,Daan Crommelin Pdf

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.

Therapeutic Proteins

Author : C. Mark Smales,David C. James
Publisher : Springer Science & Business Media
Page : 481 pages
File Size : 52,5 Mb
Release : 2008-02-04
Category : Science
ISBN : 9781592599226

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Therapeutic Proteins by C. Mark Smales,David C. James Pdf

With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Modern Pharmaceutics, Two Volume Set

Author : Alexander T. Florence,Juergen Siepmann
Publisher : CRC Press
Page : 1216 pages
File Size : 46,5 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420065718

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Modern Pharmaceutics, Two Volume Set by Alexander T. Florence,Juergen Siepmann Pdf

This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current

Protein Delivery

Author : Lynda M. Sanders,R. Wayne Hendren
Publisher : Springer Science & Business Media
Page : 433 pages
File Size : 53,5 Mb
Release : 2006-04-11
Category : Science
ISBN : 9780306468032

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Protein Delivery by Lynda M. Sanders,R. Wayne Hendren Pdf

Thirteen chapters by industrial and academic authorities in this rapidly evolving field present detailed case histories and reviews of current sophisticated protein-drug delivery technologies. Highlights include a comprehensive overview of insulin delivery and a discussion of the use of biodegradable microspheres.

Peptide and Protein Drug Analysis

Author : Ronald Reid
Publisher : CRC Press
Page : 904 pages
File Size : 43,7 Mb
Release : 1999-11-12
Category : Medical
ISBN : 9781420001334

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Peptide and Protein Drug Analysis by Ronald Reid Pdf

Furthering efforts to simulate the potency and specificity exhibited by peptides and proteins in healthy cells, this remarkable reference supplies pharmaceutical scientists with a wealth of techniques for tapping the enormous therapeutic potential of these molecules-providing a solid basis of knowledge for new drug design. Provides a broad, comprehensive overview of peptides and proteins as mediators of cell movement, proliferation, differentiation, and communication. Written by more than 50 leading international authorities, Peptides and Protein Drug Analysis discusses strategies for dealing with the complexity of peptides and proteins in conformational flexibility and amino acid sequence variability analyzes drug formulations facilitated by solid-phase peptide synthesis and recombinant DNA technology examines chemical purity analysis by high-pressure chromatographic, capillary electrophoretic, gel electrophoretic, and isoelectric focusing methods highlights drug design elements derived from protein folding, bioinformatics, and computational chemistry demonstrates uses of unnatural mutagenesis and combinatorial chemistry explores mass spectrometry, protein sequence, and carbohydrate analysis illustrates bioassays and other new functional analysis methods surveys spectroscopic techniques such as ultraviolet, fluorescence, Fourier transform infrared, and nuclear magnetic resonance (NMR) addresses ways of distinguishing between levels of therapeutic and endogenous agents in cells reviews structural analysis tools such as ultracentrifugation and light, X-ray, and neutron scattering and more! Featuring over 3400 bibliographic citations and more than 500 tables, equations, and illustrations, Peptide and Protein Drug Analysis is a must-read resource for pharmacists; pharmacologists; analytical, organic, and pharmaceutical chemists; cell and molecular biologists; biochemists; and upper-level undergraduate and graduate students in these disciplines.

Development and Manufacture of Protein Pharmaceuticals

Author : Steve L. Nail,Michael J. Akers
Publisher : Springer Science & Business Media
Page : 479 pages
File Size : 48,9 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781461505495

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Development and Manufacture of Protein Pharmaceuticals by Steve L. Nail,Michael J. Akers Pdf

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.

Membrane Transporters as Drug Targets

Author : Gordon L. Amidon,Wolfgang Sadée
Publisher : Springer Science & Business Media
Page : 547 pages
File Size : 48,7 Mb
Release : 2006-04-11
Category : Medical
ISBN : 9780306468124

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Membrane Transporters as Drug Targets by Gordon L. Amidon,Wolfgang Sadée Pdf

Because progress in the field of transporters has been extraordinary, this volume will focus on recent advances in our understanding of the structure, function, physiology, and molecular biology of membrane transporters. There will be an emphasis on transporters as molecular targets for drug delivery and disposition in the body.

Rational Design of Stable Protein Formulations

Author : John F. Carpenter,Mark C. Manning
Publisher : Springer Science & Business Media
Page : 218 pages
File Size : 50,9 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781461505570

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Rational Design of Stable Protein Formulations by John F. Carpenter,Mark C. Manning Pdf

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.

Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids

Author : Ram I. Mahato
Publisher : CRC Press
Page : 708 pages
File Size : 46,6 Mb
Release : 2004-12-28
Category : Medical
ISBN : 9780203492321

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Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids by Ram I. Mahato Pdf

Newcomers to the field of biopharmaceuticals require an understanding of the basic principles and underlying methodology involved in developing protein- and nucleic acid-based therapies for genetic and acquired diseases. Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids introduces the principles of polymer science and che