Quality by design for biopharmaceuticals

Quality by design for biopharmaceuticals: principles and case studies

by Mhatre, Rohin Rathore, Anurag S., (Anurag Singh)

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Title Statements

  • Full title :Quality by design for biopharmaceuticals : principles and case studies / edited by Anurag S. Rathore and Rohin Mhatre.

Edition Statements

  • Publication Date:©2009.

Publication Statements

  • Publisher(s):Wiley
  • Place of Publication:Hoboken, N.J
  • Language:eng
  • Publication Date:©2009.

The Physical Object

  • Description:xvi, 288 pages, 16 unnumbered pages of plates : : illustrations (some color) ; : 25 cm.

Edition Identifiers

  • ISBN:9780470282335, 0470282339
  • oclc:ocn230183366
  • LC Classification:RS380
  • Dewey Decimal:615.4

Table of Contents

Machine generated contents note: Preface to the Wiley Series on Biotechnology and Related Topics -- 1. Quality By Design: An Overview of the Basic Concepts / Anurag S. Rathore / Rohin Mhatre -- 2. Considerations For Biotechnology Product Quality By Design / Patrick Swann / Steven Kozlowski -- 3. Molecular Design of Recombinant Malaria Vaccines Expressed By Pichia pastoris / David L. Narum -- 4. Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes / Milton J. Axley / Kripa Ram / Mark A. Schenerman / Gail F. Wasserman / Cynthia N. Oliver -- 5. Case Study on Definition of Process Design Space For a Microbial Fermentation Step / Anurag S. Rathore / Jean Harms / Pim van Hoek / Xiangyang Wang -- 6. Application of QbD Principles to Tangential Flow Filtration Operations / Peter K. Watler / John Rozembersky -- 7. Applications of Design Space For Biopharmaceutical Purification Processes / Douglas J. Cecchini.

Note continued: 8. Viral Clearance: A Strategy For Quality By Design and the Design Space / Gail Sofer / Jeffrey Carter -- 9. Application of Quality By Design and Risk Assessment Principles For the Development of Formulation Design Space / Kingman Ng …

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Subjects

bioengineering Biological Factors Biological Products Biologicals Biotechnologie Biotechnologie pharmaceutique -- Qualité Biotechnology Drugs farmakologi Médicaments Pharmaceutical biotechnology Pharmaceutical biotechnology -- Quality… Pharmaceutical Preparations Pharmaceutical technology Produits biologiques Qualité -- Contrôle Quality control Techniques pharmaceutiques Technology, Pharmaceutical

Writers

Mhatre, Rohin Rathore, Anurag S., (Anurag Singh)

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