{"product_id":"9780470282335","title":"Quality by Design for Biopharmaceuticals Principles and Case Studies","description":"\u003ch3\u003eWiley Series in Biotechnology and Bioengineering\u003c\/h3\u003e\u003ch1\u003eQuality by Design for Biopharmaceuticals\u003c\/h1\u003e\u003ch2\u003ePrinciples and Case Studies\u003c\/h2\u003e\u003ch3\u003eAnurag S. Rathore | Rohin Mhatre\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eScience \/ Biotechnology\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\n\u003cb\u003eThe concepts, applications, and practical issues of Quality by Design\u003c\/b\u003e  \u003cp\u003eQuality 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eQuality by Design: Perspectives and Case Studies\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eIn this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eThe understanding and development of the product's critical quality attributes (CQA)\u003c\/li\u003e \u003cli\u003eDevelopment of the design space for a manufacturing process\u003c\/li\u003e \u003cli\u003eHow to employ QbD to design a formulation process\u003c\/li\u003e \u003cli\u003eRaw material analysis and control strategy for QbD\u003c\/li\u003e \u003cli\u003eProcess Analytical Technology (PAT) and how it relates to QbD\u003c\/li\u003e \u003cli\u003eRelevant PAT tools and applications for the pharmaceutical industry\u003c\/li\u003e \u003cli\u003eThe uses of risk assessment and management in QbD\u003c\/li\u003e \u003cli\u003eFiling QbD information in regulatory documents\u003c\/li\u003e \u003cli\u003eThe application of multivariate data analysis (MVDA) to QbD\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eFilled with vivid case studies that illustrate QbD at work in companies today, \u003ci\u003eQuality by Design\u003c\/i\u003e is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.\u003c\/p\u003e\n\u003c\/div\u003e\u003cdiv\u003e  \u003cb\u003eAnurag S. Rathore\u003c\/b\u003e received his PhD in chemical engineering from Yale University and is the Director of Process Development, Amgen Inc. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology, and quality by design. He has authored more than 100 publications and presentations in these areas and serves on the editorial advisory boards for \u003ci\u003eBiotechnology Progress, BioPharm International, Pharmaceutical Technology Europe, Journal of Biochemical and Biophysical Methods, and Separation and Purification Reviews\u003c\/i\u003e.  \u003cp\u003e\u003cb\u003eRohin Mhatre\u003c\/b\u003e is a Senior Director in the BioProcess Development department at Biogen Idec, Cambridge, Massachusetts, and has been with the company since 1996. His group is responsible for development of analytical methods and product characterization to support the process and formulation development of early and late stage clinical programs. Mhatre is also leading the QbD initiative within Biogen Idec. He has authored several publications and been an invited speaker to numerous scientific meetings.\u003c\/p\u003e\n\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e22 June 2009\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublisher: \u003c\/td\u003e\n\u003ctd\u003eWiley\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eImprint: \u003c\/td\u003e\n\u003ctd\u003eWiley-Interscience\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9780470282335\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat: \u003c\/td\u003e\n\u003ctd\u003eHardback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePage Count: \u003c\/td\u003e\n\u003ctd\u003e328\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e20.64\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":44312992153740,"sku":"9780470282335","price":154.76,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9780470282335.jpg?v=1780164513","url":"https:\/\/lateknightbooks.com\/products\/9780470282335","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}