Formulation Characterization And Stability Of Protein Drugs Case Histories
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| Author | : Rodney Pearlman |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 455 |
| Release | : 2006-04-11 |
| Genre | : Medical |
| ISBN | : 0306474522 |
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 This ready reference also features recent data and an abundance of previously unpublished information.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 | : Rodney Pearlman |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 371 |
| Release | : 2013-06-29 |
| Genre | : Medical |
| ISBN | : 1489912363 |
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 | : Pearlman |
| Publisher | : |
| Total Pages | : 460 |
| Release | : 2009-08-01 |
| Genre | : |
| ISBN | : 9788184892918 |
| Author | : John F. Carpenter |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 218 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 1461505577 |
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.
| Author | : Allan Matte |
| Publisher | : Elsevier |
| Total Pages | : 222 |
| Release | : 2020-09-07 |
| Genre | : Business & Economics |
| ISBN | : 0081030193 |
Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography
| Author | : Susanna Wu-Pong |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 374 |
| Release | : 2010-01-11 |
| Genre | : Medical |
| ISBN | : 1597455326 |
This book provides a comprehensive examination of the newest biopharmaceutical drugs. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, and contains a review of the Human Genome Project.
| Author | : Satoshi Ohtake |
| Publisher | : John Wiley & Sons |
| Total Pages | : 366 |
| Release | : 2020-02-10 |
| Genre | : Medical |
| ISBN | : 3527802118 |
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
| Author | : Rodney Pearlman |
| Publisher | : |
| Total Pages | : 464 |
| Release | : 2014-01-15 |
| Genre | : |
| ISBN | : 9781475770469 |
| Author | : Steve L. Nail |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 479 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 1461505496 |
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 | : Sandeep Nema |
| Publisher | : CRC Press |
| Total Pages | : 1145 |
| Release | : 2019-07-19 |
| Genre | : Business & Economics |
| ISBN | : 0429576838 |
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
