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 This ready reference also features recent data and an abundance of previously unpublished information.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: 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 This ready reference also features recent data and an abundance of previously unpublished information.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: 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.

Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527802118
Category : Medical
Languages : en
Pages : 366

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Book Description
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: Allan Matte
Publisher: Elsevier
ISBN: 0081030193
Category : Medical
Languages : en
Pages : 222

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Book Description
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.

Author: Damian J. Houde
Publisher: Elsevier
ISBN: 0444641742
Category : Medical
Languages : en
Pages : 588

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Book Description
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

Author: Karl-Heinz Frömming
Publisher: Springer Science & Business Media
ISBN: 9401582777
Category : Medical
Languages : en
Pages : 248

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Book Description
Nearly three thousand papers and patents are dedicated to the actual or potential uses of cyclodextrins in pharmacy and pharmaceutical formulations. This is the first book written for pharmacists and pharmaceutical technologists which not only critically summarizes the enormous amount of literature available, but which can be used as a handbook when looking for solutions to practical problems. The fundamentals -- chemistry of cyclodextrins and their derivatives -- their physical and chemical properties are condensed to the most relevant items in Chapters 1 and 2. Chapter 3 deals with the adsorption, metabolism and toxicological properties of cyclodextrins. Chapter 4 explains the formulation, structure, composition and advantageous effects of the cyclodextrin inclusion complexes. Chapter 5 describes the methods for preparation and characterization of drug/cyclodextrin complexes. Chapters 6 and 7 are dedicated to the pharmacokinetics, biopharmaceutical and technological aspects of drug/CD complexes. Chapter 8 treats the application and effects of cyclodextrins in various drug formulations. The Appendix comprises a collection of recipes for any type of drug formulation. This book is aimed at those who use cyclodextrins in drug formulations, to improve the properties of existing drug formulations, or who want to prepare quite new formulations.

Author: James N. Herron
Publisher: Boom Koninklijke Uitgevers
ISBN: 9780306450266
Category : Medical
Languages : en
Pages : 398

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Book Description
This collection of state-of-the-art research describes the most frequently used techniques for structural analysis of proteins. Chapters focus on the impressive progress that has been made in the development of these techniques and identify future trends and research needs. Papers feature several spectroscopic techniques-including fluorescence spectroscopy, circular dichroism, and infrared spectroscopy.

Author: Rohan Shah
Publisher: Springer
ISBN: 3319107119
Category : Medical
Languages : en
Pages : 105

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Book Description
​What are lipid nanoparticles? How are they structured? How are they formed? What techniques are best to characterize them? How great is their potential as drug delivery systems? These questions and more are answered in this comprehensive and highly readable work on lipid nanoparticles. This work sets out to provide the reader with a clear and understandable understanding of the current practices in formulation, characterization and drug delivery of lipid nanoparticles. A comprehensive description of the current understanding of synthesis, characterization, stability optimization and drug incorporation of solid lipid nanoparticles is provided. Nanoparticles have attracted great interest over the past few decades with almost exponential growth in their research and application. Their small particle size and subsequent high surface area make them ideal in many uses, but particularly as drug carrier systems. Nanoparticles made from lipids are especially attractive because of their enhanced biocompatibility imparted by the lipid. The work provides a detailed description of the types of lipid nanoparticles available (e.g. SLN, NLC, LDC, PLN) and how they range from imperfect crystalline to amorphous in structure. Current thoughts on where drugs are situated (e.g. in the core, or at the interface) and how this can be manipulated are discussed. The many techniques for production, including the author’s own variant of microwave heating, are fully discussed. Techniques for measuring arguably the most important characteristics of particle size and polydispersity are discussed, along with techniques to measure crystallinity, shape and drug capacity. Finally, a full chapter on techniques for measuring stability, both in the absence and presence of drugs, is discussed, along with suggestions on how to optimize that stability. This work appeals to students of colloid science, practitioners of research into drug delivery and academics alike.

Author: Lars Hovgaard
Publisher: CRC Press
ISBN: 1439853886
Category : Medical
Languages : en
Pages : 395

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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 therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.