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Quality by design for biopharmaceuticals principles and case studies /

Wiley Series in Biotechnology and bioengineering. Anurag S. Rathore, Series Editor. Quality by Design for Biopharmaceuticals. Principles and Case Studies. Edited by. Anurag S. Rathore. Rohin Mhatre. The concepts, applications, and practical issues of Quality by Design. Quality by Design (QbD) is a n...

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Bibliographic Details
Corporate Authors: Wiley InterScience (Online service)
Group Author: Rathore, Anurag S. (Anurag Singh), 1973-; Mhatre, Rohin.
Published:
Literature type: Electronic eBook
Language: English
Series: Wiley series in biotechnology and bioengineering
Subjects:
Pharmaceutical biotechnology > Quality control.
Technology, Pharmaceutical.
Biological products.
Biotechnology.
Pharmaceutical Preparations.
Quality control.
MEDICAL > Drug Guides.
MEDICAL > Pharmacology. > Pharmacology.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
Electronic books.
Online Access: http://onlinelibrary.wiley.com/book/10.1002/9780470466315
Summary: Wiley Series in Biotechnology and bioengineering. Anurag S. Rathore, Series Editor. Quality by Design for Biopharmaceuticals. Principles and Case Studies. Edited by. Anurag S. Rathore. Rohin Mhatre. 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.
Carrier Form: 1 online resource (xvi, 288 p., [16] p. of plates) : ill. (some col.)
Bibliography: Includes bibliographical references and index.
ISBN: 9780470466315
0470466316
0470282339 (Cloth)
9780470282335 (Cloth)
9780470466308 (electronic bk.)
0470466308 (electronic bk.)
Index Number: RS380
CLC: TQ464
Contents: 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: CONSI.

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