formulation and process development strategies for manufacturing biopharmaceuticals

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Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

Author : Feroz Jameel
ISBN : 9780470595879
Genre : Science
File Size : 50. 23 MB
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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 : CTI Reviews
ISBN : 9781467226240
Genre : Education
File Size : 32. 47 MB
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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.

Formulation Of Disperse Systems

Author : Tharwat F. Tadros
ISBN : 9783527336821
Genre : Science
File Size : 54. 85 MB
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This book presents comprehensively the science and technology behind the formulation of disperse systems like emulsions, suspensions, foams and others. Starting with a general introduction, the book covers a broad range of topics like the role of different classes of surfactants, stability of disperse systems, formulation of different dispersions, evaluation of formulations and many more. Many examples are included, too. Written by the experienced author and editor Tharwart Tadros, this book is indispensable for every scientist working in the field.

Spray Drying Techniques For Food Ingredient Encapsulation

Author : C. Anandharamakrishnan
ISBN : 9781118864272
Genre : Technology & Engineering
File Size : 45. 28 MB
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Spray drying is a well-established method for transforming liquid materials into dry powder form. Widely used in the food and pharmaceutical industries, this technology produces high quality powders with low moisture content, resulting in a wide range of shelf stable food and other biologically significant products. Encapsulation technology for bioactive compounds has gained momentum in the last few decades and a series of valuable food compounds, namely flavours, carotenoids and microbial cells have been successfully encapsulated using spray drying. Spray Drying Technique for Food Ingredient Encapsulation provides an insight into the engineering aspects of the spray drying process in relation to the encapsulation of food ingredients, choice of wall materials, and an overview of the various food ingredients encapsulated using spray drying. The book also throws light upon the recent advancements in the field of encapsulation by spray drying, i.e., nanospray dryers for production of nanocapsules and computational fluid dynamics (CFD) modeling. Addressing the basics of the technology and its applications, the book will be a reference for scientists, engineers and product developers in the industry.

Pharmaceutical Excipients

Author : Otilia M. Y. Koo
ISBN : 9781118145647
Genre : Medical
File Size : 46. 17 MB
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Featuring methodology, applications, and up-to-date advances through the perspectives of developers, users, and regulatory personnel,Pharmaceutical Excipients provides an overview of excipients, functionalities of excipients in pharmaceutical dosage forms, case studies, and how their selection can influence pharmaceutical products manufacture. Including up-to-date advancements of their use in the field, this valuable resource for scientists, researchers, and chemical engineers compiles ten detailed chapters that encompass the overview, applications, and most current research.

Development And Manufacture Of Protein Pharmaceuticals

Author : Steve L. Nail
ISBN : 9781461505495
Genre : Medical
File Size : 38. 12 MB
Format : PDF
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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.

Biotechnology

Author : Wulf Crueger
ISBN : 087893135X
Genre :
File Size : 73. 87 MB
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Process Validation In Manufacturing Of Biopharmaceuticals

Author : Gail Sofer
ISBN : 9781420001655
Genre : Science
File Size : 55. 91 MB
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A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

Continuous Processing In Pharmaceutical Manufacturing

Author : Ganapathy Subramanian
ISBN : 9783527673704
Genre : Medical
File Size : 54. 45 MB
Format : PDF
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With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Development Of Biopharmaceutical Parenteral Dosage Forms

Author : Cosimo Prantera
ISBN : 9780585378008
Genre : Medical
File Size : 29. 19 MB
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This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

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