Development of Sustainable Bioprocesses

Bioprocess technology involves the combination of living matter (whole organism or enzymes ) with nutrients under laboratory conditions to make a desired product within the pharmaceutical, food, cosmetics, biotechnology, fine chemicals and bulk chemicals sectors. Industry is under increasing pressure to develop new processes that are both environmentally friendly and cost-effective, and this can be achieved by taking a fresh look at process development; - namely by combining modern process modeling techniques with sustainability assessment methods. Development of Sustainable Bioprocesses: Modeling and Assessment describes methodologies and supporting case studies for the evolution and implementation of sustainable bioprocesses. Practical and industry-focused, the book begins with an introduction to the bioprocess industries and development procedures. Bioprocesses and bioproducts are then introduced, together with a description of the unit operations involved. Modeling procedures, a key feature of the book, are covered in chapter 3 prior to an overview of the key sustainability assessment methods in use (environmental, economic and societal). The second part of the book is devoted to case studies, which cover the development of bioprocesses in the pharmaceutical, food, fine chemicals, cosmetics and bulk chemicals industries. Some selected case studies include: citric acid, biopolymers, antibiotics, biopharmaceuticals. An accompanying CD-ROM will provide readers with hands-on materials so that the techniques can be put into practice. These materials include a demo version of SuperPro Designer software (used in process engineering) and models of all featured case studies, excel sheets of assessment methods, Monte Carlo simulations and exercises.

Professor Elmar Heinzle, Universität des Saarlandes, Germany

Dr. Charles Cooney, MIT, USA

Both internationally-recognised experts in biochemical engineering and modeling

Dr Arno Biwer, MIT/ Universität des Saarlandes, Germany

Preface

xiii

Acknowledgments

xvii

List of Contributors

xix

PART I THEORETICAL INTRODUCTION

1 Introduction

3

1.1 Bioprocesses

3

1.1.1 History of Biotechnology and Today's Situation

3

1.1.2 Future Perspectives

6

1.2 Modeling and Assessment in Process Development

7

2 Development of Bioprocesses

11

2.1 Types of Bioprocess and Bioproduct

11

2.1.1 Biocatalysts and Process Types

11

2.1.2 Raw Materials

17

2.1.3 Bioproducts

20

2.2 Bioreaction Stoichiometry, Thermodynamics, and Kinetics

23

2.2.1 Stoichiometry

23

2.2.2 Thermodynamics

28

2.2.3 Kinetics

29

2.3 Elements of Bioprocesses (Unit Operations and Unit Procedures)

32

2.3.1 Upstream Processing

33

2.3.2 Bioreactor

36

2.3.3 Downstream Processing

40

2.3.4 Waste Treatment, Reduction and Recycling

50

2.4 The Development Process

52

2.4.1 Introduction

52

2.4.2 Development Steps and Participants

53

3 Modeling and Simulation of Bioprocesses

61

3.1 Problem Structuring, Process Analysis, and Process Scheme

62

3.1.1 Model Boundaries and General Structure

62

3.1.2 Modeling Steps

63

3.2 Implementation and Simulation

66

3.2.1 Spreadsheet Model

66

3.2.2 Modeling using a Process Simulator

66

3.3 Uncertainty Analysis

71

4 Sustainability Assessment

81

4.1 Sustainability

81

4.2 Economic Assessment

82

4.2.1 Capital-Cost Estimation

83

4.2.2 Operating-Cost Estimation

88

4.2.3 Profitability Assessment

94

4.3 Environmental Assessment

95

4.3.1 Introduction

95

4.3.2 Structure of the Method

96

4.3.3 Impact Categories and Groups

99

4.3.4 Calculation of Environmental Factors

103

4.3.5 Calculation of Indices

105

4.3.6 Example Cleavage of Penicillin G

105

4.4 Assessing Social Aspects

107

4.4.1 Introduction

107

4.4.2 Indicators for Social Assessment

108

4.5 Interactions between the Different Sustainability Dimensions

112

PART II BIOPROCESS CASE STUDIES

Introduction to Case Studies

121

5 Citric Acid – Alternative Process using Starch

125

5.1 Introduction

125

5.2 Fermentation Model

125

5.3 Process Model

128

5.4 Inventory Analysis

130

5.5 Environmental Assessment

132

5.6 Economic Assessment

134

5.7 Conclusions

135

6 Pyruvic Acid – Fermentation with Alternative Downstream Processes

137

6.1 Introduction

137

6.2 Fermentation Model

137

6.3 Process Model

138

6.3.1 Bioreaction and Upstream

138

6.3.2 Downstream Processing

141

6.4 Inventory Analysis

142

6.5 Environmental Assessment

144

6.6 Economic Assessment

145

6.7 Conclusions

145

7 L-Lysine – Coupling of Bioreaction and Process Model

155

Arnd Knoll, Jochen Buechs

7.1 Introduction

155

7.2 Basic Strategy

156

7.3 Bioreaction Model

156

7.4 Process Model

159

7.5 Coupling of Bioreaction and Process Model

162

7.5.1 Assumptions

163

7.6 Results and Discussion

164

8 Riboflavin – Vitamin B2

169

Wilfried Storhas, Rolf Metz

8.1 Introduction

169

8.2 Biosynthesis and Fermentation

170

8.3 Production Process and Process Model

171

8.3.1 Upstream Processing

172

8.3.2 Fermentation

174

8.3.3 Downstream Processing

174

8.4 Inventory Analysis

174

8.5 Ecological Assessment

175

8.6 Economic Assessment

176

8.7 Discussion and Concluding Remarks

177

9 α-Cyclodextrin

181

9.1 Introduction

181

9.2 Reaction Model

182

9.3 Process Model

182

9.3.1 Solvent Process

182

9.3.2 Non-solvent Process

184

9.4 Inventory Analysis

185

9.5 Environmental Assessment

186

9.6 Economic Assessment

186

9.7 Conclusions

189

10 Penicillin V

193

10.1 Introduction

193

10.2 Modeling Base Case

193

10.2.1 Fermentation Model

193

10.2.2 Process Model

194

10.3 Inventory Analysis

196

10.4 Environmental Assessment

197

10.5 Economic Assessment

197

10.6 Monte Carlo Simulations

198

10.6.1 Objective Functions, Variables, and Probability Distributions

198

10.6.2 Results

201

10.7 Conclusions

206

11 Recombinant Human Serum Albumin

211

M. Abdul Kholiq, Elmar Heinzle

11.1 Introduction

211

11.2 Bioreaction Model

212

11.2.1 Stoichiometry

212

11.2.2 Multi-stage Fermentation and Feeding Plan

213

11.2.3 Total Broth Volume in Production Scale and Raw Material Consumption

214

11.3 Process Model

215

11.3.1 Bioreaction

215

11.3.2 Downstream Processing

215

11.4 Economic Assessment

218

11.5 Ecological Assessment

219

11.6 Conclusions

221

12 Recombinant Human Insulin

225

Demetri Petrides

12.1 Introduction

225

12.1.1 Two-chain Method

226

12.1.2 Proinsulin Method

226

12.2 Market Analysis and Design Basis

226

12.2.1 Process Description

227

12.2.2 Inventory Analysis and Environmental Assessment

233

12.2.3 Production Scheduling

234

12.3 Economic Assessment

235

12.4 Throughput-Increase Options

237

12.5 Conclusions

238

13 Monoclonal Antibodies

241

13.1 Introduction

241

13.2 Process Model

241

13.3 Inventory Analysis

243

13.4 Economic Assessment

245

13.5 Environmental Assessment

246

13.6 Uncertainty Analysis

247

13.6.1 Scenarios

247

13.6.2 Sensitivity Analysis

248

13.6.3 Monte Carlo Simulations

249

13.7 Conclusions

255

14 α-1-Antitrypsin from Transgenic Plant Cell Suspension Cultures

261

Elizabeth Zapalac, Karen McDonald

14.1 Introduction

261

14.2 Process Description

263

14.3 Model Description

263

14.4 Discussion

265

14.5 Conclusions

268

15 Plasmid DNA

271

Sindélia S. Freitas, José A.L. Santos, D. Miguel F. Prazeres

15.1 Introduction

271

15.1.1 General

271

15.1.2 Case Introduction

272

15.1.3 Process Description

272

15.2 Model Description

275

15.2.1 Bioreaction Section

275

15.2.2 Downstream Sections

276

15.3 Inventory Analysis

277

15.4 Economic Assessment

278

15.5 Environmental Assessment

281

15.6 Discussion

282

15.7 Conclusions

283

Index

287

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Development of Sustainable Bioprocesses Modeling and Assessment

Summary

Author Biography

Table of Contents

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