03819nam 2200685Ia 450 991102043900332120200520144314.0978661236843197811182109181118210913978128236843912823684359780470466315047046631697804704663080470466308(CKB)1000000000822020(EBL)468996(OCoLC)609847701(SSID)ssj0000307444(PQKBManifestationID)11277559(PQKBTitleCode)TC0000307444(PQKBWorkID)10244671(PQKB)10992125(MiAaPQ)EBC468996(DLC) 2017285010(Perlego)1009228(EXLCZ)99100000000082202020081030d2009 uy 0engur|n|---|||||txtccrQuality by design for biopharmaceuticals principles and case studies /edited by Anurag S. Rathore and Rohin MhatreHoboken Wileyc20091 online resource (326 p.)Wiley Series in Biotechnology and Bioengineering ;v.1Description based upon print version of record.9780470282335 0470282339 Includes bibliographical references and index.QUALITY BY DESIGN FOR BIOPHARMACEUTICALS; CONTENTS; Foreword; Preface; Preface to the Wiley Series on Biotechnology and Related Topics; Contributors; 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS; 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN; 3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris; 4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES; 5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP; 6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS7 APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE; 9 APPLICATION OF QUALITY BY DESIGN AND RISK ASSESSMENT PRINCIPLES FOR THE DEVELOPMENT OF FORMULATION DESIGN SPACE; 10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT; 11 QbD FOR RAW MATERIALS; 12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES; 13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY; IndexThe concepts, applications, and practical issues of Quality by Design Quality 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. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD Wiley Series in Biotechnology and BioengineeringPharmaceutical biotechnologyQuality controlPharmaceutical technologyQuality controlPharmaceutical biotechnologyQuality control.Pharmaceutical technologyQuality control.615/.19Mhatre Rohin1837692Rathore Anurag S(Anurag Singh),1973-1837693MiAaPQMiAaPQMiAaPQBOOK9911020439003321Quality by design for biopharmaceuticals4416484UNINA