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Formulation, Characterization, and Stability of Protein Drugs

Formulation, Characterization, and Stability of Protein Drugs PDF Author: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 9780306453328
Category : Medical
Languages : en
Pages : 470

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 This ready reference also features recent data and an abundance of previously unpublished information.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

Formulation, Characterization, and Stability of Protein Drugs

Formulation, Characterization, and Stability of Protein Drugs PDF Author: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 9780306453328
Category : Medical
Languages : en
Pages : 470

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 This ready reference also features recent data and an abundance of previously unpublished information.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

Formulation, Characterization, and Stability of Protein Drugs

Formulation, Characterization, and Stability of Protein Drugs PDF Author: Rodney Pearlman
Publisher:
ISBN: 9781475770469
Category :
Languages : en
Pages : 464

Book Description


Formulation, Characterization, And Stability Of Protein Drugs: Case Histories

Formulation, Characterization, And Stability Of Protein Drugs: Case Histories PDF Author: Pearlman
Publisher:
ISBN: 9788184892918
Category :
Languages : en
Pages : 460

Book Description


Protein Formulation and Delivery

Protein Formulation and Delivery PDF Author: Eugene J. McNally
Publisher: CRC Press
ISBN: 0849379520
Category : Medical
Languages : en
Pages : 372

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

Stability and Characterization of Protein and Peptide Drugs

Stability and Characterization of Protein and Peptide Drugs PDF Author: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 1489912363
Category : Medical
Languages : en
Pages : 371

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.

Rational Design of Stable Protein Formulations

Rational Design of Stable Protein Formulations PDF Author: John F. Carpenter
Publisher: Springer Science & Business Media
ISBN: 1461505577
Category : Medical
Languages : en
Pages : 218

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.

Formulation, Characterization, and Stability of Protein Drugs

Formulation, Characterization, and Stability of Protein Drugs PDF Author: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 0306474522
Category : Medical
Languages : en
Pages : 455

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.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition PDF Author: Lars Hovgaard
Publisher: CRC Press
ISBN: 1439853886
Category : Medical
Languages : en
Pages : 395

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.

Physical Methods to Characterize Pharmaceutical Proteins

Physical Methods to Characterize Pharmaceutical Proteins PDF Author: James N. Herron
Publisher: Springer Science & Business Media
ISBN: 1489910794
Category : Medical
Languages : en
Pages : 374

Book Description
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.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications PDF Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527341129
Category : Medical
Languages : en
Pages : 394

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.