Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre

• Record Nr.: UNINA9910139982903321
• Pubbl/distr/stampa: Hoboken, : Wiley, c2009
• ISBN: 1-118-21091-3; 1-282-36843-5; 9786612368431; 0-470-46631-6; 0-470-46630-8
• Descrizione fisica: 1 online resource (326 p.)
• Collana: Wiley Series in Biotechnology and Bioengineering ; ; v.1
• Altri autori (Persone): MhatreRohin; RathoreAnurag S <1973-> (Anurag Singh)
• Disciplina: 615.19; 615/.19
• Soggetti: Pharmaceutical biotechnology - Quality control; Pharmaceutical technology - Quality control; Electronic books.
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 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 OPERATIONS; 7 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; Index
• Sommario/riassunto: The 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