{"text_format":"2","workbook":"xls","n_sheets":1,"sheets":["report2"],"not_rendered":{"charts":0,"images":0,"macros":0,"external_links":1,"defined_names":1,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"run_cost":"one","rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"report2","index":0,"n_rows":24,"n_cols":5,"rows_kept":24,"cut":false,"hidden":false,"merged":[[0,2,0,3],[0,4,0,5],[1,2,1,3],[1,4,1,5],[2,2,2,3],[3,2,3,3],[8,2,8,3],[9,2,9,3],[10,2,10,3],[12,2,12,3],[15,2,15,3],[16,2,16,3],[20,2,20,3]],"flags":["formulas_cached_only"]}
[null,"1.","Record Nr.",null,"UNINA9910139982903321"]
[null,null,"Titolo",null,"Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, : Wiley, c2009"]
[null,null,"ISBN",null,"1-118-21091-3"]
[{"$nulls":4},"1-282-36843-5"]
[{"$nulls":4},"9786612368431"]
[{"$nulls":4},"0-470-46631-6"]
[{"$nulls":4},"0-470-46630-8"]
[null,null,"Descrizione fisica",null,"1 online resource (326 p.)"]
[null,null,"Collana",null,"Wiley Series in Biotechnology and Bioengineering ; ; v.1"]
[null,null,"Disciplina",null,"615.19"]
[{"$nulls":4},"615/.19"]
[null,null,"Soggetti",null,"Pharmaceutical biotechnology - Quality control"]
[{"$nulls":4},"Pharmaceutical technology - Quality control"]
[{"$nulls":4},"Electronic books."]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Description based upon print version of record."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"QUALITY BY DESIGN FOR BIOPHARMACEUTICALS; CONTENTS; Foreword; Preface; Preface to the Wiley Series on Biotechnology and Related Topics; Contributors; 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS; 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN; 3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris; 4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES; 5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP; 6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS"]
[{"$nulls":4},"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 "]
[{"$nulls":4},"INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY; Index"]
[null,null,null,"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"]