Description

Book Synopsis
Universities worldwide are establishing biomanufacturing centers, and demand is growing for a workforce trained in this discipline. Downstream Recovery and Purification is an affordable, accessible desk reference on biomanufacturing for professionals, instructors, and students.

Trade Review

“The reference should be valuable to industry professionals as well as to advanced students of biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology.” (Chemical Engineering Progress, 1 August 2013)



Table of Contents

Preface ix

Contributors xi

PART I INTRODUCTION 1

1 Bioprocess Design, Computer-Aided 5
Victor Papavasileiou, Charles Siletti, Alexandros Koulouris, and Demetri Petrides

PART II DOWNSTREAM RECOVERY OF CELLS AND PROTEIN CAPTURE 25

2 Cell Separation, Centrifugation 27
Hans Axelsson

3 Cell Disruption, Micromechanical Properties 49
Ingo Kampen and Arno Kwade

4 Cell Separation, Yeast Flocculation 65
Eduardo V. Soares

5 Cell Wall Disruption and Lysis 81
F. A. P. Garcia

6 Expanded Bed Chromatography, Surface Energetics of Biomass Deposition 95
Marcelo Fernandez Lahore, Oscar Aguilar, Rami Reddy Vennapusa and Muhammad Aasin

7 Filter Aids 107
Tony Hunt

8 Protein Adsorption, Expanded Bed 115
Siddartha Ghose

PART III PROCESS DEVELOPMENT IN DOWNSTREAM PURIFICATION 127

9 Scaledown of Biopharmaceutical Purification Operations 129
Anurag S. Rathore and Varsha S. Joshi

10 Adsorption in Simulated Moving Beds (SMB) 147
Cesar C. Santana, Ivanildo J. Silva Jr., Diana C. S. Azevedo, and Amaro G. Barreto Jr.

11 Adsorption of Proteins with Synthetic Materials 179
Joseph McGuire and Omkar Joshi

12 Affinity Fusions for Protein Purification 191
Susanne Gräslund and Martin Hammarström

13 Bioseparation, Magnetic Particle Adsorbents 201
Urs Alexander Peuker, Owen Thomas, Timothy John Hobley, Mathias Franzreb, Sonja Berensmeier, Maria Shäfer, and Birgit Hickstein

14 High Throughput Technologies in Bioprocess Development 221
Trent Carrier, Eva Heldin, Mattias Ahnfelt, Eggert Brekkan, Richard Hassett, Steve Peppers, Gustav Rodrigo, Greg Van Slyke, and David (Xiqaojian) Zhao

15 Large-Scale Protein Purification, Self-Cleaving Aggregation Tags 257
Iraj Ghazi and David W. Wood

16 Lipopolysaccharide, LPS removal, Depyrogenation 269
Pérola O. Magalhães and Adalberto Pessoa Jr.

17 Porous Media in Biotechnology 277
Manuel Mota, Alexander Yelshin, and Inna Yelshina

18 Protein Aggregation and Precipitation, Measurement and Control 293
Catherine H. Schein

PART IV EQUIPMENT DESIGN FOR DOWNSTREAM RECOVERY AND PROTEIN PURIFICATION 325

19 Cleaning and Sanitation in Downstream Processes 327
Gail Sofer, Craig Robinson, Joanthan Yourkin, Tina Pitarresi, and Darcy Birse

20 Clean-in-place 343
Phil J. Bremer and Richard Brent Seale

21 Large Scale Chromatography Columns, Modeling Flow Distribution 353
Zhiwu Fang

22 Pumps, Industrial 373
Bob Stover and Ed Domanico

PART V DOWNSTREAM cGMP OPERATIONS 389

23 Affinity Chromatography of Plasma Proteins 391
Mirjana Radosevich and Thierry Burnouf

24 Antibody Purification, Monoclonal and Polyclonal 405
James J. Reilly and Michiel E. Ultee

25 Chromatographic Purification of Virus Particles 415
Pete Gagnon

26 Chromatography, Hydrophobic Interactions 437
Per Karsnäs

27 Chromatography, Radar Flow 449
Tingyue Gu

28 Drying, Biological Materials 465
Chung Lim Law and Arun S. Mujumdar

29 Freeze-Drying, Pharmaceuticals 485
Jinsong Liu

30 Freezing, Biopharmaceutical 505
Philippe Lam and Jamie Moore

31 Membrane Chromatography 521
John Pieracci and Jörg Thömmes

32 Membrane Separations 545
Manohar Kalyanpur

33 Plasmid Purification 557
H .S. C. Barbosa and J. C. Marcos

34 Protein Chromatography, Manufacturing Scale 571
Joseph Bertolini

35 Protein Crystallization, Kinetics 579
Gianluca Di Profio, Efrem Curcio, and Enrico Drioli

36 Protein Purification, Aqueous Liquid Extraction 603
Maria-Regina Kula and Klaus Selber

37 Protein Ultrafiltration 617
Robert van Reis and Andrew L. Zydney

38 Virus Retentive Filters 641
George Miesegaes, Scott Lute, Hazel Aranha, and Kurt Brorson

PART VI BIOPHARMACEUTICAL FACILITY VALIDATION 655

39 Biopharmaceutical Facility Design and Validation 657
Jeffrey N. Odum

40 Closed Systems in Bioprocessing 677
Jeffrey Odum

41 Facility Design for Single Use (SU) Downstream Materials 685
Robert Z. Maigetter, Tom Piombino, Christian Wood, Tom Gervais, Claudio Thomasin, Bryan Shingle, Dave A. Wareheim, and David Clark

42 eGMPs for Production Rooms 715
Claude Arlois, Jean Didelez, Patrick Florent, and Guy Godeau

43 Heating, Ventilation, and Air Conditioning 731
Dennis Dobie

44 Sterilization-in-Place (SIP) 747
P. T. Noble

PART VII FDA cGMP REGULATORY COMPLIANCE 757

45 Pharmaceutical Bioburden Testing 759
Nathaniel G. Hentz, PhD

46 Chromatography, Industrial Scale Validation 775
Sandy Weinberg and Carl A. Rockburne

47 GMPs and GLSPs 795
Beth H. Junker

48 Quality by Design (QBD) 815
Rakhi B. Shah, Jun T. Park, Erik K. Read, Mansoor A. Khan, and Kurt Brorson

49 Regulatory Requirements, European Community 829
Gary Walsh

Index 843

Downstream Industrial Biotechnology

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    A Hardback by MC Flickinger

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      Publisher: Wiley-Blackwell
      Publication Date:
      ISBN13: 9781118131244, 978-1118131244
      ISBN10:
      Also in:
      Chemistry Industrial chemistry and chemical engineering

      Description

      Book Synopsis
      Universities worldwide are establishing biomanufacturing centers, and demand is growing for a workforce trained in this discipline. Downstream Recovery and Purification is an affordable, accessible desk reference on biomanufacturing for professionals, instructors, and students.

      Trade Review

      “The reference should be valuable to industry professionals as well as to advanced students of biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology.” (Chemical Engineering Progress, 1 August 2013)



      Table of Contents

      Preface ix

      Contributors xi

      PART I INTRODUCTION 1

      1 Bioprocess Design, Computer-Aided 5
      Victor Papavasileiou, Charles Siletti, Alexandros Koulouris, and Demetri Petrides

      PART II DOWNSTREAM RECOVERY OF CELLS AND PROTEIN CAPTURE 25

      2 Cell Separation, Centrifugation 27
      Hans Axelsson

      3 Cell Disruption, Micromechanical Properties 49
      Ingo Kampen and Arno Kwade

      4 Cell Separation, Yeast Flocculation 65
      Eduardo V. Soares

      5 Cell Wall Disruption and Lysis 81
      F. A. P. Garcia

      6 Expanded Bed Chromatography, Surface Energetics of Biomass Deposition 95
      Marcelo Fernandez Lahore, Oscar Aguilar, Rami Reddy Vennapusa and Muhammad Aasin

      7 Filter Aids 107
      Tony Hunt

      8 Protein Adsorption, Expanded Bed 115
      Siddartha Ghose

      PART III PROCESS DEVELOPMENT IN DOWNSTREAM PURIFICATION 127

      9 Scaledown of Biopharmaceutical Purification Operations 129
      Anurag S. Rathore and Varsha S. Joshi

      10 Adsorption in Simulated Moving Beds (SMB) 147
      Cesar C. Santana, Ivanildo J. Silva Jr., Diana C. S. Azevedo, and Amaro G. Barreto Jr.

      11 Adsorption of Proteins with Synthetic Materials 179
      Joseph McGuire and Omkar Joshi

      12 Affinity Fusions for Protein Purification 191
      Susanne Gräslund and Martin Hammarström

      13 Bioseparation, Magnetic Particle Adsorbents 201
      Urs Alexander Peuker, Owen Thomas, Timothy John Hobley, Mathias Franzreb, Sonja Berensmeier, Maria Shäfer, and Birgit Hickstein

      14 High Throughput Technologies in Bioprocess Development 221
      Trent Carrier, Eva Heldin, Mattias Ahnfelt, Eggert Brekkan, Richard Hassett, Steve Peppers, Gustav Rodrigo, Greg Van Slyke, and David (Xiqaojian) Zhao

      15 Large-Scale Protein Purification, Self-Cleaving Aggregation Tags 257
      Iraj Ghazi and David W. Wood

      16 Lipopolysaccharide, LPS removal, Depyrogenation 269
      Pérola O. Magalhães and Adalberto Pessoa Jr.

      17 Porous Media in Biotechnology 277
      Manuel Mota, Alexander Yelshin, and Inna Yelshina

      18 Protein Aggregation and Precipitation, Measurement and Control 293
      Catherine H. Schein

      PART IV EQUIPMENT DESIGN FOR DOWNSTREAM RECOVERY AND PROTEIN PURIFICATION 325

      19 Cleaning and Sanitation in Downstream Processes 327
      Gail Sofer, Craig Robinson, Joanthan Yourkin, Tina Pitarresi, and Darcy Birse

      20 Clean-in-place 343
      Phil J. Bremer and Richard Brent Seale

      21 Large Scale Chromatography Columns, Modeling Flow Distribution 353
      Zhiwu Fang

      22 Pumps, Industrial 373
      Bob Stover and Ed Domanico

      PART V DOWNSTREAM cGMP OPERATIONS 389

      23 Affinity Chromatography of Plasma Proteins 391
      Mirjana Radosevich and Thierry Burnouf

      24 Antibody Purification, Monoclonal and Polyclonal 405
      James J. Reilly and Michiel E. Ultee

      25 Chromatographic Purification of Virus Particles 415
      Pete Gagnon

      26 Chromatography, Hydrophobic Interactions 437
      Per Karsnäs

      27 Chromatography, Radar Flow 449
      Tingyue Gu

      28 Drying, Biological Materials 465
      Chung Lim Law and Arun S. Mujumdar

      29 Freeze-Drying, Pharmaceuticals 485
      Jinsong Liu

      30 Freezing, Biopharmaceutical 505
      Philippe Lam and Jamie Moore

      31 Membrane Chromatography 521
      John Pieracci and Jörg Thömmes

      32 Membrane Separations 545
      Manohar Kalyanpur

      33 Plasmid Purification 557
      H .S. C. Barbosa and J. C. Marcos

      34 Protein Chromatography, Manufacturing Scale 571
      Joseph Bertolini

      35 Protein Crystallization, Kinetics 579
      Gianluca Di Profio, Efrem Curcio, and Enrico Drioli

      36 Protein Purification, Aqueous Liquid Extraction 603
      Maria-Regina Kula and Klaus Selber

      37 Protein Ultrafiltration 617
      Robert van Reis and Andrew L. Zydney

      38 Virus Retentive Filters 641
      George Miesegaes, Scott Lute, Hazel Aranha, and Kurt Brorson

      PART VI BIOPHARMACEUTICAL FACILITY VALIDATION 655

      39 Biopharmaceutical Facility Design and Validation 657
      Jeffrey N. Odum

      40 Closed Systems in Bioprocessing 677
      Jeffrey Odum

      41 Facility Design for Single Use (SU) Downstream Materials 685
      Robert Z. Maigetter, Tom Piombino, Christian Wood, Tom Gervais, Claudio Thomasin, Bryan Shingle, Dave A. Wareheim, and David Clark

      42 eGMPs for Production Rooms 715
      Claude Arlois, Jean Didelez, Patrick Florent, and Guy Godeau

      43 Heating, Ventilation, and Air Conditioning 731
      Dennis Dobie

      44 Sterilization-in-Place (SIP) 747
      P. T. Noble

      PART VII FDA cGMP REGULATORY COMPLIANCE 757

      45 Pharmaceutical Bioburden Testing 759
      Nathaniel G. Hentz, PhD

      46 Chromatography, Industrial Scale Validation 775
      Sandy Weinberg and Carl A. Rockburne

      47 GMPs and GLSPs 795
      Beth H. Junker

      48 Quality by Design (QBD) 815
      Rakhi B. Shah, Jun T. Park, Erik K. Read, Mansoor A. Khan, and Kurt Brorson

      49 Regulatory Requirements, European Community 829
      Gary Walsh

      Index 843

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