Protein Instability At Interfaces During Drug Product Development

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Protein Instability at Interfaces During Drug Product Development

Author : Jinjiang Li
Publisher : Springer Nature
ISBN 13 : 3030571777
Total Pages : 338 pages
Book Rating : 4.0/5 (35 download)

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Book Synopsis Protein Instability at Interfaces During Drug Product Development by : Jinjiang Li

Download or read book Protein Instability at Interfaces During Drug Product Development written by Jinjiang Li and published by Springer Nature. This book was released on 2021-02-12 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.

Surfactants in Biopharmaceutical Development

Author : Atanas V. Koulov
Publisher : Academic Press
ISBN 13 : 0128125691
Total Pages : 236 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Surfactants in Biopharmaceutical Development by : Atanas V. Koulov

Download or read book Surfactants in Biopharmaceutical Development written by Atanas V. Koulov and published by Academic Press. This book was released on 2023-08-12 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surfactants in Biopharmaceutical Development addresses the progress, challenges and opportunities for surfactant research specific to pharmaceutical development, providing a broad range of important surfactant-related topics as they relate directly to the biopharmaceutical process. Chapters address fundamental topics, like mechanisms of protein stabilization by surfactants, the latest, state-of-the-art technology and methods to illustrate the practical application to biopharmaceutical development, forward-looking chapters on control strategies and novel surfactants, with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients by the industry and by regulators. - Describes the current state of research on surfactants in the context of biopharmaceutical development, drawing upon contributions from international experts across industry, academia, and regulators - Addresses the opportunities and challenges associated with surfactants in biologic drug development - Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics by summarizing the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume

Challenges in Protein Product Development

Author : Nicholas W. Warne
Publisher : Springer
ISBN 13 : 3319906038
Total Pages : 596 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Challenges in Protein Product Development by : Nicholas W. Warne

Download or read book Challenges in Protein Product Development written by Nicholas W. Warne and published by Springer. This book was released on 2018-06-20 with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Development and Manufacture of Protein Pharmaceuticals

Author : Steve L. Nail
Publisher : Springer Science & Business Media
ISBN 13 : 1461505496
Total Pages : 479 pages
Book Rating : 4.4/5 (615 download)

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Book Synopsis Development and Manufacture of Protein Pharmaceuticals by : Steve L. Nail

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.

Development of Biopharmaceutical Drug-Device Products

Author : Feroz Jameel
Publisher : Springer Nature
ISBN 13 : 3030314154
Total Pages : 888 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Development of Biopharmaceutical Drug-Device Products by : Feroz Jameel

Download or read book Development of Biopharmaceutical Drug-Device Products written by Feroz Jameel and published by Springer Nature. This book was released on 2020-03-13 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Dosage Form Design Considerations

Author :
Publisher : Academic Press
ISBN 13 : 0128144246
Total Pages : 881 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Dosage Form Design Considerations by :

Download or read book Dosage Form Design Considerations written by and published by Academic Press. This book was released on 2018-07-28 with total page 881 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Pharmaceutical Excipients

Author : Otilia M. Y. Koo
Publisher : John Wiley & Sons
ISBN 13 : 1118992423
Total Pages : 369 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Pharmaceutical Excipients by : Otilia M. Y. Koo

Download or read book Pharmaceutical Excipients written by Otilia M. Y. Koo and published by John Wiley & Sons. This book was released on 2016-10-03 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Aggregation of Therapeutic Proteins

Author : Wei Wang
Publisher : John Wiley & Sons
ISBN 13 : 1118043588
Total Pages : 400 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Aggregation of Therapeutic Proteins by : Wei Wang

Download or read book Aggregation of Therapeutic Proteins written by Wei Wang and published by John Wiley & Sons. This book was released on 2010-12-28 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.

Parenteral Medications, Fourth Edition

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 042957472X
Total Pages : 2781 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Parenteral Medications, Fourth Edition by : Sandeep Nema

Download or read book Parenteral Medications, Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 2781 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Principles and Practices of Lyophilization in Product Development and Manufacturing

Author : Feroz Jameel
Publisher : Springer Nature
ISBN 13 : 3031126343
Total Pages : 621 pages
Book Rating : 4.0/5 (311 download)

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Book Synopsis Principles and Practices of Lyophilization in Product Development and Manufacturing by : Feroz Jameel

Download or read book Principles and Practices of Lyophilization in Product Development and Manufacturing written by Feroz Jameel and published by Springer Nature. This book was released on 2023-04-24 with total page 621 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on “Preservation of Biologicals” comprised of nine chapters written by experts and including case studies.

Managing the Drug Discovery Process

Author : Susan Miller
Publisher : Elsevier
ISBN 13 : 0128243058
Total Pages : 684 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Managing the Drug Discovery Process by : Susan Miller

Download or read book Managing the Drug Discovery Process written by Susan Miller and published by Elsevier. This book was released on 2023-03-09 with total page 684 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing the Drug Discovery Process, Second Edition thoroughly examines the current state of pharmaceutical research and development by providing experienced perspectives on biomedical research, drug hunting and innovation, including the requisite educational paths that enable students to chart a career path in this field. The book also considers the interplay of stakeholders, consumers, and drug firms with respect to a myriad of factors. Since drug research can be a high-risk, high-payoff industry, it is important to students and researchers to understand how to effectively and strategically manage both their careers and the drug discovery process. This new edition takes a closer look at the challenges and opportunities for new medicines and examines not only the current research milieu that will deliver novel therapies, but also how the latest discoveries can be deployed to ensure a robust healthcare and pharmacoeconomic future. All chapters have been revised and expanded with new discussions on remarkable advances including CRISPR and the latest gene therapies, RNA-based technologies being deployed as vaccines as well as therapeutics, checkpoint inhibitors and CAR-T approaches that cure cancer, diagnostics and medical devices, entrepreneurship, and AI. Written in an engaging manner and including memorable insights, this book is aimed at anyone interested in helping to save countless more lives through science. A valuable and compelling resource, this is a must-read for all students, educators, practitioners, and researchers at large—indeed, anyone who touches this critical sphere of global impact—in and around academia and the biotechnology/pharmaceutical industry. - Considers drug discovery in multiple R&D venues - big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes - with a clear description of the degrees and training that will prepare students well for a career in this arena - Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work - Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable - Addresses new areas such as CRISPR gene editing technologies and RNA-based drugs and vaccines, personalized medicine and ethical and moral issues, AI/machine learning and other in silico approaches, as well as completely updating all chapters

Excipient Applications in Formulation Design and Drug Delivery

Author : Ajit S Narang
Publisher : Springer
ISBN 13 : 3319202065
Total Pages : 700 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Excipient Applications in Formulation Design and Drug Delivery by : Ajit S Narang

Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Author : Satoshi Ohtake
Publisher : John Wiley & Sons
ISBN 13 : 3527802118
Total Pages : 366 pages
Book Rating : 4.5/5 (278 download)

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Book Synopsis Drying Technologies for Biotechnology and Pharmaceutical Applications by : Satoshi Ohtake

Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-02-10 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Protein Pharmaceuticals

Author : Hanns-Christian Mahler
Publisher :
ISBN 13 : 9783871933820
Total Pages : 464 pages
Book Rating : 4.9/5 (338 download)

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Book Synopsis Protein Pharmaceuticals by : Hanns-Christian Mahler

Download or read book Protein Pharmaceuticals written by Hanns-Christian Mahler and published by . This book was released on 2010 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biodrug Delivery Systems

Author : Mariko Morishita
Publisher : CRC Press
ISBN 13 : 1420086715
Total Pages : 488 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Biodrug Delivery Systems by : Mariko Morishita

Download or read book Biodrug Delivery Systems written by Mariko Morishita and published by CRC Press. This book was released on 2016-04-19 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development presents the work of an international group of leading experts in drug development and biopharmaceutical science who discuss the latest advances in biodrug delivery systems and associated techniques. The book discusses components of successful formulation, delivery, and p

Rational Design of Stable Protein Formulations

Author : John F. Carpenter
Publisher : Springer Science & Business Media
ISBN 13 : 1461505577
Total Pages : 218 pages
Book Rating : 4.4/5 (615 download)

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Book Synopsis Rational Design of Stable Protein Formulations by : John F. Carpenter

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.

Therapeutic Fc-Fusion Proteins

Author : Steven M. Chamow
Publisher : John Wiley & Sons
ISBN 13 : 3527675280
Total Pages : 345 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Therapeutic Fc-Fusion Proteins by : Steven M. Chamow

Download or read book Therapeutic Fc-Fusion Proteins written by Steven M. Chamow and published by John Wiley & Sons. This book was released on 2013-12-18 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future. An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.