Download or read book Rational Design of Stable Protein Formulations written by John F. Carpenter and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Stability of Protein Pharmaceuticals written by Tim J. Ahern and published by . This book was released on 1992-11-30 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first of two volumes examines the chemical and physical mechanisms of degradation processes that occur during drug processing, storage, and delivery. The practical text will be particularly useful to molecular biologists, process engineers, and pharmaceutical scientists in the field of biotechnology.
Download or read book Stability of Protein Pharmaceuticals In vivo pathways of degradation and strategies for protein stabilization written by Tim J. Ahern and published by . This book was released on 1992 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Formulation Characterization and Stability of Protein Drugs written by Rodney Pearlman and published by Springer Science & Business Media. This book was released on 2006-04-11 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 This ready reference also features recent data and an abundance of previously unpublished information.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.
Download or read book Protein Purification Protocols written by Paul Cutler and published by Springer Science & Business Media. This book was released on 2008-02-02 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of Protein Purification Protocols (1996), edited by Professor Shawn Doonan, rapidly became very successful. Professor Doonan achieved his aims of p- ducing a list of protocols that were invaluable to newcomers in protein purification and of significant benefit to established practitioners. Each chapter was written by an ex- rienced expert in the field. In the intervening time, a number of advances have w- ranted a second edition. However, in attempting to encompass the recent developments in several areas, the intention has been to expand on the original format, retaining the concepts that made the initial edition so successful. This is reflected in the structure of this second edition. I am indebted to Professor Doonan for his involvement in this new edition and the continuity that this brings. Each chapter that appeared in the original volume has been reviewed and updated to reflect advances and bring the topic into the 21st century. In many cases, this reflects new applications or new matrices available from vendors. Many of these have increased the performance and/or scope of the given method. Several new chapters have been introduced, including chapters on all the currently used protein fractionation and ch- matographic techniques. They introduce the theory and background for each method, providing lists of the equipment and reagents required for their successful execution, as well as a detailed description of how each is performed.
Download or read book Stability and Characterization of Protein and Peptide Drugs written by Rodney Pearlman and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Modern Pharmaceutics written by Gilbert S. Banker and published by CRC Press. This book was released on 2002-05-24 with total page 1255 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration."
Download or read book Biosimilarity written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-03 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars
Download or read book Protein Purification Protocols written by Shawn Doonan and published by Springer Science & Business Media. This book was released on 2008-02-02 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hans Neurath has written that this is the second golden era of enzymology {Protein Science [1994], vol. 3, pp. 1734—1739); he could with justice have been more general and referred to the second golden age of protein chemistry. The last two decades have seen enormous advances in our understanding of the structures and functions of pro teins arising on the one hand from improvements and developments in analytical techniques {see the companion volume, Basic Protein and Peptide Protocols, in this series) and on the other hand from the tech nologies of molecular genetics. Far from turning the focus away from protein science, the ability to isolate, analyze, and express genes has increased interest in proteins as gene products. Hence, many laborato ries are now getting involved in protein isolation for the first time, either as an essential adjunct to their work in molecular genetics or because of a curiosity to know more about the products of the genes that they have been studying. Protein Purification Protocols is aimed mainly at these newcom ers to protein purification, but it is hoped that it will also be of value to established practitioners who may find here techniques that they have not tried, but which might well be most applicable in their work. With the exception mainly of the first and last chapters, the format of the contributions to the present book conform to the established format of the Methods in Molecular Biology series.
Download or read book Development and Manufacture of Protein Pharmaceuticals written by Steve L. Nail and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Modern Analytical Ultracentrifugation written by Todd M. Schuster and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are numerous examples in the history of science when the parallel develop ments of two or more disciplines, methodologies, technologies or theoretical in sights have converged to produce significant scientific advances. The decades following the 1950s have produced several such significant advances, as a result of a convergence of developments in molecular biology and in solid state-based electronics instrumentation. Since one of these areas of significant advancement, analytical ultracentrifu gation, has been undergoing a renaissance, we thought it would be a useful activity to call upon a group of researchers who have been developing either the experi mental or theoretical aspects of the methodology and gather in one place a group of articles summarizing the current status of the field. The success of recombinant DNA methodologies at producing biologically active macromolecules of commer cial interest has evoked interests in mechanisms of function. Pursuit of the related questions has emphasized the importance of studies of macromolecular binding and interaction. Several contributions to this volume remind us that analytical ultra centrifugation is rigorously based on solid thermodynamic theory and, as such, is fully capable of providing comprehensive quantitative descriptions of molecular interactions in solution. Furthermore, a number of the chapters provide examples, along with innovative methods for carrying out these characterizations. The past decade has seen several developments that reflect the rebirth of interest in analytical ultracentrifugation.
Download or read book Bioseparations of Proteins written by Ajit Sadana and published by Elsevier. This book was released on 1997-11-27 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the fundamentals of protein inactivation during bioseparation and the effect on protein processing. Bioseparation of Proteins is unique because it provides a background of the bioseparation processes, and it is the first book available to emphasize the influence of the different bioseparation processes on protein inactivation.Bioseparation of Proteins covers the extent, mechanisms of, and control of protein inactivation during these processes along with the subsequent and essential validation of these processes. The book focuses on the avoidance of protein (biologicalproduct) inactivation at each step in a bioprocess. It compares protein inactivation exhibited during the different bioseparation processes by different workers and provides a valuable framework for workers in different areas interested in bioseparations.Topics include separation and detection methods; estimates of protein inactivation and an analysis of this problem for different separation processes; strategies for avoiding inactivation; the molecular basis of surface activity and protein adsorption,process monitoring, and product validation techniques; and the economics of various bioseparation processes and quality control procedures.Key Features* Protein inactivation and other aspects of biological stability are critical to an effective bioseparation process; This book is a detailed and critical review of the available literature in an area that is essential to the effectiveness, validation, and economics of bioseparation processes for drugs and other biological products; Conveniently assembled under one cover, the survey of the literature and resulting perspective will greatly assist engineers and chemists in designingand improving their own processes; Key features of the text include:* detailed data on biological stability under various bioseparation conditions* extensive case studies from the literature on separation processes, validation, and economics* simplified analysis of protein refolding and inactivation mechanisms* consideration of adsorption theories and the effect of heterogeneity* coverage of both classical and novel bioseparation techniques, including chromatographic procedures
Download or read book Development of Biopharmaceutical Parenteral Dosage Forms written by Cosimo Prantera and published by CRC Press. This book was released on 1997-07-25 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Formsdetails biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable.
Download or read book Advances in Plant Physiology Vol 14 written by A. Hemantaranjan and published by Scientific Publishers. This book was released on 2013-11-01 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt: In view of changes in the global environment, it is important to determine and developing technologies to ameliorate metabolic limitations by biological processes most sensitive to abiotic stress factors warning crop productivity. It is reaffirmed that publishing the important Treatise Series has been undertaken with a view to identify the inadequacies under varied environments and to scientifically extend precise and meaningful research so that the significant outcomes including new technologies are judiciously applied for requisite productivity, profitability and sustainability of agriculture. Besides this, meticulous research in some of the very sensible and stirring areas of Plant Physiology-Plant Molecular Physiology are indispensably needed for holistic development of agriculture and crop production in different agro-climatic zones. Ardently, this is also to focus upon excellent new ideas ensuring the best science done across the full extent of modern plant biology, in general, and plant physiology, in particular. In Volume 14, with inventive applied research, attempts have been made to bring together much needed eighteen remarkable review articles distributed in three appropriate major sections of Nutriophysiology and Crop Productivity, Plant Responses to Changing Environment and Environmental Stresses and Technological Innovations in Agriculture written by thirty four praiseworthy contributors of eminence in unequivocal fields mainly from premier institutions of India and abroad. In reality, the Volume 14 of the Treatise Series is wealth for interdisciplinary exchange of information particularly in the field of nutriophysiology and abiotic stresses for planning meaningful research and related education programmes in these thrust areas. Apart from fulfilling the heightened need of this kind of select edition in different volumes for research teams and scientists engaged in various facets of research in Plant Physiology/Plant Sciences in traditional and agricultural universities, institutes and research laboratories throughout the world, it would be tremendously a productive reference book for acquiring advanced knowledge by post-graduate and Ph.D. scholars in response to the innovative courses in Plant Physiology, Plant Biochemistry, Plant Molecular Biology, Plant Biotechnology, Environ-mental Sciences, Plant Pathology, Microbiology, Soil Science & Agricultural Chemistry, Agronomy, Horticulture, and Botany.
Download or read book Physiology of Nutrition and Environmental Stresses on Crop Productivity written by A. Hemantaranjan and published by Scientific Publishers. This book was released on 2014-01-01 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book has meticulous research in some of the very sensible and stirring areas of Plant Physiology-Plant Molecular Physiology are indispensably needed for holistic development of agriculture and crop production in different agroclimatic zones. It would be tremendously a productive reference book for acquiring advanced knowledge by post-graduate and Ph.D. scholars in response to the innovative courses in Plant Physiology, Plant Biochemistry, Plant Molecular Biology, Plant Biotechnology, Environmental Sciences, Plant Pathology, Microbiology, Soil Science & Agricultural Chemistry, Agronomy, Horticulture, and Botany.
Download or read book Therapeutic Peptides and Proteins written by Ajay K. Banga and published by CRC Press. This book was released on 2015-04-23 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Protein Pharmacokinetics and Metabolism written by Bobbe L. Ferraiolo and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Investigation of the pharmacokinetics and metabolism of human proteins has escalated over the last two decades because of the use of recombinant human proteins as therapeutic agents. In addition, the development and improvement of analytical techniques enabling the detection of minute quantities of proteins in biological matrices have aided this process. In assembling this volume, we sought to provide a state-of-the-art as sessment of the pharmacokinetics and metabolism of protein therapeutics through complete reviews of selected examples. A comprehensive review of all protein therapeutics was not attempted; the majority -of the therapeutic protein classes and crucial scientific issues have been addressed, however. Therefore, we are confident that this volume will provide a useful reference for scientists in this field. The volume has been divided into two general parts. The first part (Chapters 1-3) is composed of general reviews of topics of importance in pharmacokinetic/metabolism studies of proteins: goals and analytical meth odologies, effects of binding proteins, and effects of antibody induction, respectively. The second part (Chapters 4-8) consists of specific, detailed reviews by therapeutic protein class: growth factors and hormones, cyto kines, cardiovascular proteins, hematopoietic proteins, and antibodies, respectively. The editors are grateful to the contributors for the patience, personal sacrifice and perseverance required to complete this volume. BoDDE L. FERRAIOLO MARJORIE A. MOHLER CAROL A. GLOFF ix Contents Chapter 1 Goals and Analytical Methodologies for Protein Disposition Studies Bobbe L. Ferraiolo and Marjorie A. Mohler 1. Introduction ................................................. .
