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Studyguide for Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Jameel, Feroz

2013-05
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Release : 2013-05
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Kind : eBook
Book Rating : 417/5 ( reviews)

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Book Synopsis Studyguide for Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Jameel, Feroz by : Cram101 Textbook Reviews

Download or read book Studyguide for Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Jameel, Feroz written by Cram101 Textbook Reviews. This book was released on 2013-05. Available in PDF, EPUB and Kindle. Book excerpt: Never HIGHLIGHT a Book Again Virtually all testable terms, concepts, persons, places, and events are included. Cram101 Textbook Outlines gives all of the outlines, highlights, notes for your textbook with optional online practice tests. Only Cram101 Outlines are Textbook Specific. Cram101 is NOT the Textbook. Accompanys: 9780521673761

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

2010-08-09 Science
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Release : 2010-08-09
Genre : Science
Kind : eBook
Book Rating : 121/5 ( reviews)

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Book Synopsis Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by : Feroz Jameel

Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel. This book was released on 2010-08-09. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Outlines and Highlights for Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Feroz Jameel

2011-08 Business & Economics
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Release : 2011-08
Genre : Business & Economics
Kind : eBook
Book Rating : 295/5 ( reviews)

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Book Synopsis Outlines and Highlights for Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Feroz Jameel by : Cram101 Textbook Reviews

Download or read book Outlines and Highlights for Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Feroz Jameel written by Cram101 Textbook Reviews. This book was released on 2011-08. Available in PDF, EPUB and Kindle. Book excerpt: Never HIGHLIGHT a Book Again! Virtually all of the testable terms, concepts, persons, places, and events from the textbook are included. Cram101 Just the FACTS101 studyguides give all of the outlines, highlights, notes, and quizzes for your textbook with optional online comprehensive practice tests. Only Cram101 is Textbook Specific. Accompanys: 9780470118122 .

Quality by Design for Biopharmaceutical Drug Product Development

2015-04-01 Medical
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Release : 2015-04-01
Genre : Medical
Kind : eBook
Book Rating : 161/5 ( reviews)

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Book Synopsis Quality by Design for Biopharmaceutical Drug Product Development by : Feroz Jameel

Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel. This book was released on 2015-04-01. Available in PDF, EPUB and Kindle. Book excerpt: 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.

High-Throughput Formulation Development of Biopharmaceuticals

2016-09-29 Medical
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Release : 2016-09-29
Genre : Medical
Kind : eBook
Book Rating : 76X/5 ( reviews)

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Book Synopsis High-Throughput Formulation Development of Biopharmaceuticals by : Vladimir I. Razinkov

Download or read book High-Throughput Formulation Development of Biopharmaceuticals written by Vladimir I. Razinkov. This book was released on 2016-09-29. Available in PDF, EPUB and Kindle. Book excerpt: High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

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