Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals
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Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals
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Author : Feroz Jameel
language : en
Publisher: John Wiley & Sons
Release Date : 2010-08-09
Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals written by Feroz Jameel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-08-09 with Science categories.
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.
Biopharmaceutical Manufacturing
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Author : Gary Gilleskie
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2021-09-07
Biopharmaceutical Manufacturing written by Gary Gilleskie and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-07 with Science categories.
Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:
Biopharmaceutical Production Technology
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2012-05-14
Biopharmaceutical Production Technology written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-14 with Medical categories.
Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.
Quality By Design For Biopharmaceutical Drug Product Development
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Author : Feroz Jameel
language : en
Publisher: Springer
Release Date : 2015-04-01
Quality By Design For Biopharmaceutical Drug Product Development written by Feroz Jameel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-01 with Medical categories.
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.
Recent Development Of Electrospinning For Drug Delivery
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Author : Romána Zelkó
language : en
Publisher: MDPI
Release Date : 2020-03-27
Recent Development Of Electrospinning For Drug Delivery written by Romána Zelkó and has been published by MDPI this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-27 with Medical categories.
Several promising techniques have been developed to overcome the poor solubility and/or membrane permeability properties of new drug candidates, including different fiber formation methods. Electrospinning is one of the most commonly used spinning techniques for fiber formation, induced by the high voltage applied to the drug-loaded solution. With modifying the characteristics of the solution and the spinning parameters, the functionality-related properties of the formulated fibers can be finely tuned. The fiber properties (i.e., high specific surface area, porosity, and the possibility of controlling the crystalline–amorphous phase transitions of the loaded drugs) enable the improved rate and extent of solubility, causing a rapid onset of absorption. However, the enhanced molecular mobility of the amorphous drugs embedded into the fibers is also responsible for their physical–chemical instability. This Special Issue will address new developments in the area of electrospun nanofibers for drug delivery and wound healing applications, covering recent advantages and future directions in electrospun fiber formulations and scalability. Moreover, it serves to highlight and capture the contemporary progress in electrospinning techniques, with particular attention to the industrial feasibility of developing pharmaceutical dosage forms. All aspects of small molecule or biologics-loaded fibrous dosage forms, focusing on the processability, structures and functions, and stability issues, are included.
Protein Therapeutics 2 Volume Set
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Author : Tristan Vaughan
language : en
Publisher: John Wiley & Sons
Release Date : 2017-12-04
Protein Therapeutics 2 Volume Set written by Tristan Vaughan and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-04 with Medical categories.
Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche.
Introduction To Pharmaceutical Technology Development
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Author : Yaser Dahman
language : en
Publisher: Elsevier
Release Date : 2025-02-24
Introduction To Pharmaceutical Technology Development written by Yaser Dahman and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-02-24 with Medical categories.
Introduction to Pharmaceutical Technology Development: Journey from Lab to Shelf of Commercial Pharmaceutical Drugs is a complete reference and learning resource for those working in pharmaceutics or aspiring to join the industry. The book provides a comprehensive view into all aspects of drug discovery, approval, and production. Using examples of well-known drugs and their journeys from lab to market, the book provides a comprehensive overview of all steps involved in bringing new drugs, including biologics, to the shelves.Topics covered include Drug Discovery, Pharmaceutical Formulations of Different Dose Form, Analytical Testing and Development, Unit Operations and Design for Major Equipment, Basics of Analytics and Process Validations and Protocols (DQ, IQ, OQ, PQ) in FDA-Regulated Industries.This book provides graduate students from several areas with a solid foundation of the Pharmaceutic industry across key stages on new drug lifecycle. - Provides readers with introductory information on the developments in pharmaceutical technology - Includes complete coverage of equipment and unit operations relevant across the production cycle of drugs - Illustrates the path to commercialization through studies on the journey of several common commercially available formulated medications
Drying Technologies For Biotechnology And Pharmaceutical Applications
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Author : Satoshi Ohtake
language : en
Publisher: John Wiley & Sons
Release Date : 2020-02-03
Drying Technologies For Biotechnology And Pharmaceutical Applications written by Satoshi Ohtake and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-02-03 with Medical categories.
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.
Pharmaceutical Biotechnology
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Author : Oliver Kayser
language : en
Publisher: John Wiley & Sons
Release Date : 2012-03-27
Pharmaceutical Biotechnology written by Oliver Kayser and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-27 with Science categories.
This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.
Biophysical Methods For Biotherapeutics
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Author : Tapan K. Das
language : en
Publisher: John Wiley & Sons
Release Date : 2014-04-28
Biophysical Methods For Biotherapeutics written by Tapan K. Das and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-28 with Medical categories.
With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.