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Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
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 pa...
Quality by Design for Biopharmaceutical Drug Product Development
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...
Isolation and Purification of Proteins
This publication details the isolation of proteins from biological materials, techniques for solid-liquid separation, concentration, crystallization, chromatography, scale-up, process monitoring, product formulation, and regulatory and commercial considerations in protein production. The authors discuss the release of protein from a biological host, selectivity in affinity chromatography, precipitation of proteins (both non-specific and specific), extraction for rapid protein isolation, adsorption as an initial step for the capture of proteins, scale-up and commercial production of recombinant proteins, and process monitoring in downstream processing.
Process Validation in Manufacturing of Biopharmaceuticals
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 wh
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
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 pa...
We Are Smarter Than Me
Wikinomics and The Wisdom of Crowds identified the phenomena of emerging social networks, but they do not confront how businesses can profit from the wisdom of crowds. WE ARE SMARTER THAN ME by Barry Libert and Jon Spector, Foreword by Wikinomics author Don Tapscott, is the first book to show anyone in business how to profit from the wisdom of crowds. Drawing on their own research and the insights from an enormous community of more than 4,000 people, Barry Libert and Jon Spector have written a book that reveals what works, and what doesn't, when you are building community into your decision making and business processes. In We Are Smarter Than Me, you will discover exactly how to use social ...
My New Roots
Holistic nutritionist and highly-regarded blogger Sarah Britton presents a refreshing, straight-forward approach to balancing mind, body, and spirit through a diet made up of whole foods. Sarah Britton's approach to plant-based cuisine is about satisfaction--foods that satiate on a physical, emotional, and spiritual level. Based on her knowledge of nutrition and her love of cooking, Sarah Britton crafts recipes made from organic vegetables, fruits, whole grains, beans, lentils, nuts, and seeds. She explains how a diet based on whole foods allows the body to regulate itself, eliminating the need to count calories. My New Roots draws on the enormous appeal of Sarah Britton's blog, which strike...
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Energy Accounts
How does one tell the story of energy production, use, or conservation in a manner sufficiently convincing to influence policy, behavior, and design? Energy Accounts explores potential answers to this question through compelling images, data visualizations, narratives, and other examples of accounting for energy. Organized into a collection containing both examples of best practices and critiques, this impressive array of projects and contributors combines text and graphic material to explore different representations of energy data. Including work from Kieran Timberlake, SHoP, AMO, Lateral Office, WOHA, and many more, the book boasts a unique graphic design which supports and enhances its role as a valuable resource for professionals and students in architecture, engineering, and urban design.
