Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470595876
Format: PDF
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A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470118121
Format: PDF, ePub
Download Now
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: Feroz Jameel
Publisher: Wiley
ISBN: 0470595876
Format: PDF, ePub, Docs
Download Now
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: CTI Reviews
Publisher: Cram101 Textbook Reviews
ISBN: 1467226246
Format: PDF, Mobi
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Facts101 is your complete guide to Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals. In this book, you will learn topics such as as those in your book plus much more. With key features such as key terms, people and places, Facts101 gives you all the information you need to prepare for your next exam. Our practice tests are specific to the textbook and we have designed tools to make the most of your limited study time.

Development and Manufacture of Protein Pharmaceuticals

Author: Steve L. Nail
Publisher: Springer Science & Business Media
ISBN: 1461505496
Format: PDF, ePub, Mobi
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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.

Quality by Design for Biopharmaceuticals

Author: Anurag S. Rathore
Publisher: John Wiley & Sons
ISBN: 1118210913
Format: PDF, ePub, Docs
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The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Quality by Design for Biopharmaceutical Drug Product Development

Author: Feroz Jameel
Publisher: Springer
ISBN: 1493923161
Format: PDF
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This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Crystallization

Author: Wolfgang Beckmann
Publisher: John Wiley & Sons
ISBN: 3527650342
Format: PDF, Docs
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Crystallization is a natural occurring process but also a process abundantly used in the industry. Crystallization can occur from a solution, from the melt or via deposition of material from the gas phase (desublimation). Crystals distinguish themself from liquids, gases and amorphous substances by the long-range order of its building blocks that entail the crystals to be formed of well-defined faces, and give rise to a large number of properties of the solid. Crystallization is used at some stage in nearly all process industries as a method of production, purification or recovery of solid materials. Crystallization is practiced on all scales: from the isolation of the first milligrams of a newly synthesized substance in the research laboratory to isolating products on the mulit-million tonne scale in industry. The book describes the breadth of crystallization operations, from isolation from a reaction broth to purification and finally to tailoring product properties. In the first section of the book, the basic mechanisms - nucleation, growth, attrition and agglomeration are introduced. It ensures an understanding of supersaturation, the driving force of crystallization. Furthermore, the solubility of the substance and its dependences on process conditions and the various techniques of crystallization and their possibilities and limitations are discussed. Last but not least, the first part includes an intensive treatment of polymorphism . The second part builds on the basics, exploring how crystallization processes can be developed, either batch-wise or continuous, from solution or from the melt. A discussion of the purification during crystallization serves as a link between the two sections, where practical aspects and an insight using theoretical concepts are combined. Mixing and its influence on the crystallization as well as the mutual interference of down-stream processes with the crystallization are also treated. Finally, techniques to characterize the crop are discussed. The third part of the book is dedicated to accounts of actual developments and of carried-out crystallizations. Typical pitfalls and strategies to avoid these as well as the design of robust processes are presented.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author: Damian J. Houde
Publisher: Newnes
ISBN: 0444595902
Format: PDF, Mobi
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Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with 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 takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered. Presents the reader with a clear understanding of the real world issues and challenges in using these methods. Highlights the capabilities and limitations of each method. Discusses how to best analyze the data generated from these methods. Points out what one needs to look for to avoid making faulty conclusions and mistakes. In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author: Gintaras V. Reklaitis
Publisher: John Wiley & Sons
ISBN: 0470942371
Format: PDF, Mobi
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This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.