Industrial Scale Suspension Culture of Living Cells - Hans-Peter Meyer - E-Book

Industrial Scale Suspension Culture of Living Cells E-Book

Hans-Peter Meyer

0,0
147,99 €

oder
-100%
Sammeln Sie Punkte in unserem Gutscheinprogramm und kaufen Sie E-Books und Hörbücher mit bis zu 100% Rabatt.
Mehr erfahren.
Beschreibung

The submersed cultivation of organisms in sterile containments or fermenters has become the standard manufacturing procedure, and will remain the gold standard for some time to come. This book thus addresses submersed cell culture and fermentation and its importance for the manufacturing industry. It goes beyond expression systems and integrally investigates all those factors relevant for manufacturing using suspension cultures. In so doing, the contributions cover all industrial cultivation methods in a comprehensive and comparative manner, with most of the authors coming from the industry itself. Depending on the maturity of the technology, the chapters address in turn the expression system, basic process design, key factors affecting process economics, plant and bioreactor design, and regulatory aspects.

Sie lesen das E-Book in den Legimi-Apps auf:

Android
iOS
von Legimi
zertifizierten E-Readern

Seitenzahl: 1244

Veröffentlichungsjahr: 2014

Bewertungen
0,0
0
0
0
0
0
Mehr Informationen
Mehr Informationen
Legimi prüft nicht, ob Rezensionen von Nutzern stammen, die den betreffenden Titel tatsächlich gekauft oder gelesen/gehört haben. Wir entfernen aber gefälschte Rezensionen.



CONTENTS

Cover

Related Titles

Title Page

Copyright

Foreword

Preface

List of Contributors

The History and Economic Relevance of Industrial Scale Suspension Culture of Living Cells

Part I: Suspension Culture of Bacteria, Yeasts, and Filamentous Fungi

Chapter 1: Bacterial Suspension Cultures

1.1 Introduction

1.2 Organisms, Cells, and their Products

1.3 Bioprocess Design Aspects for Recombinant Products

1.4 Basic Bioreactor Design Aspects

1.5 Single Use Bioreactors for Microbial Cultivation

1.6 Quality by Design: Vision or Threat for Twenty-First Century Pharmaceutical Manufacturing

1.7 Process Economics

References

Chapter 2: Yeast Suspension Culture

2.1 Introduction

2.2 Yeast Species Used in Biotechnology and their Products

2.3 Basic Process Design Aspects

2.4 Basic Bioreactor Design Aspects

2.5 Key Factors Related to Process Economics

2.6 Regulatory Aspects

2.7 Summary and Outlook

References

Chapter 3: Filamentous Fungi Fermentation

3.1 Introduction

3.2 Products and Organisms in the Industry

3.3 Filamentous Fungi as a Production Platform

3.4 Fermentation of Filamentous Organisms

3.5 Process Scaling

3.6 Regulatory Aspects

3.7 Economic Aspects

3.8 Conclusions and Perspectives

References

Part II: Suspension Culture of Algae and Plant Cells

Chapter 4: Microalgae Grown under Heterotrophic and Mixotrophic Conditions

4.1 Eco-physiology and Genetics of Biotechnologically Relevant Species

4.2 Products from Microalgae Grown in the Absence of Light

4.3 Bioreactor Design

4.4 Process Design: Culture Media and Process Control Strategies

4.5 Process Economics

4.6 Commercialization of Microalgae-Derived Products and Regulatory Aspects

References

Chapter 5: Recombinant Protein Production with Microalgae

5.1 Organisms, Cells, Expression Systems, Products

5.2 Production of Recombinant Therapeutics in Microalgae: Process Design Aspects

5.3 Regulatory Aspects

5.4 Summary and Outlook

References

Chapter 6: Suspension Culture of Microorganisms (Algae and Cyanobacteria) Under Phototrophic Conditions

6.1 Introduction

6.2 Basic Process Design Aspects

6.3 Large-Scale Cultivation Systems

6.4 Photobioreactors – Technology Overview

6.5 Conclusion/Outlook

References

Chapter 7: Suspension Culture of Plant Cells Under Heterotrophic Conditions

7.1 Introduction

7.2 In Vitro Initiation and Maintenance of Plant Cell Suspension Cultures

7.3 Characteristics of Heterotrophic Plant Suspension Cells and Resulting Process Design

7.4 Suitable Bioreactors

7.5 Commercial Manufacture of Plant Cell-Derived Cosmetics and Therapeutics under Additional Consideration of Economic and Regulatory Aspects

7.6 Conclusion

References

Chapter 8: Suspension Culture of Plant Cells Under Phototrophic Conditions

8.1 Introduction

8.2 BryoTechnology™: Production of Biologics with Moss (Physcomitrella patens)

8.3 The LEX-System: Production of Biologics with Duckweed (Lemna minor)

8.4 Key Factors Related to Process Economics

8.5 Regulatory Aspects

References

Part III: Suspension Culture of Protozoa, Insect Cells, Avian Cells, and Mammalian Cells

Chapter 9: Suspension Culture of Protozoan Organisms

9.1 Introduction

9.2 Ciliates

9.3 Flagellates

9.4 Regulatory Aspects of Protozoan Production Organism

9.5 Summary and Outlook

References

Chapter 10: Industrial Large Scale of Suspension Culture of Insect Cells

10.1 History

10.2 Concepts in Insect Cell Culture

10.3 Regulatory Hurdles for Insect Derived Human Products

10.4 What Comes Next?

References

Chapter 11: Avian Suspension Culture Cell Lines for Production of Vaccines and Other Biologicals

11.1 Development of Cell Culture for the Production of Vaccines and Biologicals

11.2 Avian Cell Lines

11.3 Potential of Avian Cell Lines for the Manufacture of Vaccines and Biologicals

11.4 Development of Avian Cell Lines

11.5 Basic Process Design Aspects

11.6 Basic Bioreactor Design Aspects

11.7 Key Factors Related to Process Economics

11.8 Regulatory Aspects

11.9 Summary and Outlook

References

Chapter 12: Large Scale Suspension Culture of Mammalian Cells

12.1 Introduction to Mammalian Cell Culture1

12.2 Cell Lines and Expression Technologies2

12.3 Bioreactor Design3

12.4 Process Operation4

12.5 Process Economics of Mammalian Cell Culture5

12.6 Regulatory Aspects6

12.7 Summary and Outlook7

References

Part IV: Suspension Culture for Special Products

Chapter 13: Pillars of Regenerative Medicine: Therapeutic Human Cells and Their Manufacture

13.1 Introduction

13.2 Autologous Therapies

13.3 Allogeneic Therapies

13.4 Downstream Processing

13.5 Key Factors Towards Economic Success

13.6 Regulatory Considerations

13.7 Summary and Outlook

Acknowledgements

References

Chapter 14: Virus Production Under Suspension Conditions

14.1 Introduction

14.2 Adherent versus Suspension Culture for Virus Production

14.3 Polio Virus/Vaccines

14.4 Influenza Virus/Vaccines

14.5 Modified Vaccinia Ankara (MVA) Production in Suspension Cell Lines

14.6 Production of Viruses for Gene Therapy Purpose

14.7 Other Viruses

14.8 Concluding Remarks

References

Chapter 15: Cultivable Marine Organisms as a Source of New Products

15.1 Introduction

15.2 Substances of Interest Isolated from Archaea and Prokaryotes

15.3 Substances of Interest Isolated from Unicellular Eukaryotes

15.4 Substances of Interest Isolated from Microorganisms Associated with Pluricellular Organisms

15.5 Substances of Interest Produced by Sponge Cell Culture

15.6 Substances of Interest Isolated by Culture of Macroorganisms

15.7 Conclusion and Future Prospects

References

Index

End User License Agreement

List of Tables

Table 1.1

Table 1.2

Table 1.3

Table 1.4

Table 1.5

Table 1.6

Table 1.7

Table 1.8

Table 1.9

Table 1.10

Table 1.11

Table 1.12

Table 1.13

Table 1.14

Table 2.1

Table 2.2

Table 2.3

Table 2.4

Table 2.5

Table 2.6

Table 2.7

Table 2.8

Table 2.9

Table 2.10

Table 2.11

Table 2.12

Table 3.1

Table 3.2

Table 4.1

Table 4.2

Table 6.1

Table 6.2

Table 6.3

Table 6.4

Table 6.5

Table 7.1

Table 7.2

Table 7.3

Table 8.1

Table 8.2

Table 9.1

Table 9.2

Table 9.3

Table 9.4

Table 9.5

Table 10.1

Table 10.2

Table 10.3

Table 11.1

Table 11.2

Table 11.3

Table 12.1

Table 12.2

Table 12.3

Table 12.4

Table 12.5

Table 12.6

Table 12.7

Table 13.1

Table 13.2

Table 13.3

Table 14.1

Table 14.2

Table 14.3

Table 14.4

Table 14.5

Table 14.6

Table 15.1

Table 15.2

Table 15.3

Table 15.4

Table 15.5

Table 15.6

Table 15.7

Table 15.8

List of Illustrations

Figure 1.1

Figure 1.2

Figure 1.3

Figure 1.4

Figure 1.5

Figure 1.6

Figure 1.7

Figure 1.8

Figure 1.9

Figure 1.10

Figure 1.11

Figure 1.12

Figure 1.13

Figure 1.14

Figure 1.15

Figure 1.16

Figure 1.17

Figure 1.18

Figure 2.1

Figure 2.2

Figure 2.3

Figure 2.4

Figure 2.5

Figure 2.6

Figure 2.7

Figure 2.8

Figure 3.1

Figure 3.2

Figure 3.3

Figure 3.4

Figure 3.5

Figure 3.6

Figure 3.7

Figure 3.8

Figure 3.9

Figure 3.10

Figure 3.11

Figure 3.12

Figure 4.1

Figure 4.2

Figure 4.3

Figure 4.4

Figure 5.1

Figure 6.1

Figure 6.2

Figure 6.3

Figure 6.4

Figure 7.1

Figure 7.2

Figure 7.3

Figure 7.4

Figure 7.5

Figure 7.6

Figure 7.7

Figure 7.8

Figure 7.9

Figure 7.10

Figure 7.11

Figure 7.12

Figure 7.13

Figure 7.14

Figure 8.1

Figure 8.2

Figure 8.3

Figure 8.4

Figure 8.5

Figure 8.6

Figure 8.7

Figure 8.8

Figure 8.9

Figure 8.10

Figure 8.11

Figure 9.1

Figure 9.2

Figure 9.3

Figure 9.4

Figure 9.5

Figure 9.6

Figure 9.7

Figure 9.8

Figure 9.9

Figure 9.10

Figure 9.11

Figure 9.12

Figure 9.13

Figure 9.14

Figure 9.15

Figure 9.16

Figure 10.1

Figure 10.2

Figure 11.1

Figure 11.2

Figure 12.1

Figure 12.2

Figure 12.3

Figure 12.4

Figure 12.5

Figure 12.6

Figure 12.7

Figure 12.8

Figure 13.1

Figure 13.2

Figure 13.3

Figure 13.4

Figure 13.5

Figure 13.6

Figure 14.1

Figure 14.2

Figure 14.3

Figure 14.4

Figure 15.1

Figure 15.2

Figure 15.3

Figure 15.4

Figure 15.5

Figure 15.6

Figure 15.7

Figure 15.8

Figure 15.9

Figure 15.10

Guide

Cover

Table of Contents

Begin Reading

Begin Reading

Part 1

Chapter 1

Pages

ii

iii

iv

v

vi

xxi

xxii

xxiii

xxiv

xxv

xxvi

xxvii

xxix

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

117

118

119

120

121

122

123

124

125

126

127

128

129

130

131

132

133

134

135

136

137

138

139

140

141

142

143

144

145

146

147

148

149

150

151

152

153

154

155

156

157

158

159

160

161

162

163

164

165

166

167

168

169

170

171

172

173

174

175

176

177

178

179

180

181

182

183

184

185

186

187

188

189

190

191

192

193

194

195

196

197

198

199

200

201

202

203

204

205

206

207

208

209

210

211

212

213

214

215

216

217

218

219

220

221

222

223

224

225

226

227

228

229

230

231

232

233

234

235

236

237

238

239

240

241

242

243

244

245

246

247

248

249

250

251

252

253

254

255

256

257

258

259

260

261

262

263

264

265

266

267

268

269

270

271

272

273

274

275

276

277

278

279

280

281

282

283

284

285

286

287

288

289

290

291

292

293

294

295

296

297

298

299

300

301

302

303

304

305

306

307

308

309

310

311

312

313

314

315

316

317

318

319

320

321

322

323

324

325

326

327

328

329

330

331

332

333

334

335

336

337

338

339

340

341

342

343

344

345

346

347

348

349

350

351

352

353

354

355

356

357

358

359

360

361

362

363

364

365

366

367

368

369

370

371

372

373

374

375

376

377

378

379

380

381

382

383

384

385

386

387

388

389

390

391

392

393

394

395

396

397

398

399

400

401

402

403

404

405

406

407

408

409

410

411

412

413

414

415

416

417

418

419

420

421

422

423

424

425

426

427

428

429

430

431

432

433

434

435

436

437

438

439

440

441

442

443

444

445

446

447

448

449

450

451

452

453

454

455

456

457

458

459

460

461

462

463

464

465

466

467

468

469

470

471

472

473

474

475

476

477

478

479

480

481

482

483

484

485

486

487

488

489

490

491

492

493

494

495

496

497

498

499

500

501

502

504

504

505

506

507

508

509

510

511

512

513

514

515

516

517

518

519

520

521

522

523

524

525

526

527

528

529

530

531

532

533

534

535

536

537

538

539

540

541

542

543

544

545

546

547

548

549

550

551

552

553

554

555

556

557

558

559

560

561

562

563

564

565

566

567

568

569

570

571

572

573

574

575

576

577

578

579

580

581

582

583

584

585

586

587

588

589

590

591

592

593

594

595

596

597

598

599

600

601

602

603

604

605

606

607

608

609

610

611

612

Related Titles

Mozzi, F., Raya, R.R., Vignolo, G.M. (eds.)

Biotechnology of Lactic Acid Bacteria

2010

Print ISBN: 978-0-813-81583-1, also available in digital formats

Buchholz, K., Kasche, V., Bornscheuer, U.T.

Biocatalysts and Enzyme Technology

2 Edition

2012

Print ISBN: 978-3-527-32989-2, also available in digital formats

Kayser, O., Warzecha, H. (eds.)

Pharmaceutical Biotechnology

Drug Discovery and Clinical Applications

2 Edition

2012

Print ISBN: 978-3-527-32994-6, also available in digital formats

Feldmann, H. (ed.)

Yeast

Molecular and Cell Biology

2 Edition

2013

Print ISBN: 978-3-527-33252-6, also available in digital formats

Richmond, A., Hu, Q. (eds.)

Handbook of Microalgal Culture - Applied Phycologyand Biotechnology 2e

2 Edition

2013

Print ISBN: 978-0-470-67389-8, also available in digital formats

Lindl, T., Steubing, R.

Atlas of Living Cell Cultures

2013

Print ISBN: 978-3-527-32887-1, also available in digital formats

Industrial Scale Suspension Culture of Living Cells

Edited by

Hans-Peter Meyer

Diego R. Schmidhalter

Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty can be created or extended by sales representatives or written sales materials. The Advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Library of Congress Card No.: applied for

British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library.

Bibliographic information published by the Deutsche Nationalbibliothek The Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed bibliographic data are available on the Internet at <http://dnb.d-nb.de>.

© 2014 Wiley-VCH Verlag GmbH & Co. KGaA, Boschstr. 12, 69469 Weinheim, Germany

Wiley-Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley's global Scientific, Technical, and Medical business with Blackwell Publishing.

All rights reserved (including those of translation into other languages). No part of this book may be reproduced in any form – by photoprinting, microfilm, or any other means – nor transmitted or translated into a machine language without written permission from the publishers. Registered names, trademarks, etc. used in this book, even when not specifically marked as such, are not to be considered unprotected by law.

Print ISBN: 978-3-527-33547-3

ePDF ISBN: 978-3-527-68334-5

ePub ISBN: 978-3-527-68335-2

Mobi ISBN: 978-3-527-68333-8

oBook ISBN: 978-3-527-68332-1

Foreword

Biotechnology has the potential to move our economy to prosperity and sustainability. Today, this “bioeconomy” is estimated to be worth over 2 trillion euros, providing over 20 million jobs and accounting for 9% of the European Union's total employment. And as the editors of this volume point out, the industrial-scale suspension culture already has global annual sales of over $250 billion, with products ranging from pharmaceuticals, cosmetics, chemicals, industrial enzymes, food, dietary supplements, and feed products.

Especially in the context of climate change, the world's growing population will need a safe and secure supply of food, water, and energy. We must move toward processing systems that can produce more with fewer inputs, less environmental impact, and reduced greenhouse gas emissions. Bio-based industries can play a significant role in this transition toward a more resource-efficient society.

The bioeconomy can only thrive within an environment of intense basic and applied research and efficient innovation. Challenges include scaling up processes and improving quality control, taking into account both risks and benefits. Process standardization, harmonization of standards, and regulation are essential to support the creation of new markets and opportunities. This volume is a welcome contribution to this endeavor.

The scale up of production traditionally lies outside the research portfolio of universities and has to be taken up by the relevant industries. Of course, the large-scale suspension culture is old and well established; after all beer and wine have been around for thousands of years, and the Reinheitsgebot of 1487 defining beer production is probably the oldest biotechnology regulation. Yet academia has a critical role to play in developing cutting-edge technologies for the large-scale suspension culture. Harnessing the astonishing chemical creativity of plants to produce structurally complex metabolites and bioplastics and developing new protein expression systems (in insect, avian, or protozoan cells) are currently budding areas of research. Synthetic biology, until recently a futuristic dream, has now become a toolbox that will soon be central to manufacturing.

Stem cell technology is another recent development. But to become relevant in the clinic, issues involving scalability, safety, and cost of production still have to be settled. The same can be said about the production of vaccines and viral vectors for gene therapy. Moving forward, innovation in processing technology and bioreactor design for scalable, fully-controlled manufacturing processes will be paramount, and there is ample room for collaboration between industry and academia.

Until now, suspension culture has utilized bacteria, yeast, and filamentous fungi. In the twenty-first century, the biotechnology revolution will broaden its scope, benefitting many people around the world.

Lausanne, March 2014

Patrick Aebischer

President of Swiss Federal Institute of Technology in Lausanne (EPFL)

Preface

Why did we decide to edit this book? Both of us have been active in the biotechnology industry for more than 30 years. We have experienced exciting times, and have been personally involved in the production of recombinant proteins and other products using many different eukaryotic and prokaryotic organisms. During our professional careers, the commercial importance of biotechnology has probably grown by at least an order of magnitude, and it is still growing. Biotechnology affects practically all areas of our lives. Biotechnology can also provide sustainable solutions for many problems that a growing global population is facing today and will face tomorrow. We both have often wondered, how the industry looks in detail, and how it will develop in the future.

The idea for the book actually came from a book chapter we wrote together on the relevance of “microbial expression systems and manufacturing from a market and economic perspective.” We compared different expression systems and realized how little is known about which systems manufacturing industry is using, and how they value the different suspension culture methods. At least 95% of all applications use large-scale cell suspension culture, the remaining 5% are mainly genetically engineered crops. During one of our opulent monthly brainstorming lunches, which always comes with an excellent bottle of wine, we decided to try to assemble a group of industrial and academic authors who would be prepared to share their views with us. It was not an easy task, but we believe we have succeeded, and it was a pleasure to see how the academic and industrial contributors finally struggled constructively together in writing industrially relevant chapters.

Submersed production of organisms in sterile containments or fermenters has become the standard manufacturing process and it will remain the gold standard for quite some time to come. This book therefore addresses submersed cell culture and fermentation, and its importance for the manufacturing industry. It goes beyond expression systems and integrally investigates all those factors relevant for manufacturing using suspension cultures. One of the key features of the book is that it covers all suspension cultivation methods in a comprehensive and comparative manner in a single volume.

The book focuses on the industrial and manufacturing world, with a majority of contributing authors coming from industry. To make reading easier, each chapter has a similar structure. Depending on the maturity of the technology, the chapters address in turn the expression system, basic process design, key factors affecting process economics, plant and bioreactor design, and regulatory aspects.

After an introduction on the history and economic relevance of industrial scale suspension culture of living cells, the chapters are separated into four groups:

Suspension culture of bacteria, yeast, and filamentous fungi

Suspension culture of algae and plant cells

Suspension culture of protozoa, insect cells, avian cells, and mammalian cells

Suspension culture for special products

An important feature of the book is that the majority of the authors are from the industry itself. The reader therefore gets a “real picture” of what is going on in the manufacturing world.

The book should serve as an overview and guidance for advanced students and other academics interested in industrial aspects of cell and microbial cultivation, and for product developers and others interested in different modes of sterile suspension cultures and fermentations of industrial or commercial interest. We really hope you will enjoy the book as a valuable contribution and we would appreciate any constructive comments you might have.

Lonza AG, Switzerland, March 2014

Hans-Peter Meyer

Diego R. Schmidhalter

List of Contributors

Patrick Aebischer

President of EPFL

École Polytechnique Fédérale de

Lausanne

Centre Est, Station 1

1015 Lausanne

Switzerland

Richard M. Alldread

National Biologics Manufacturing Centre

Centre for Process Innovation (CPI)

Wilton Centre, Wilton

Redcar

Cleveland, TS10 4RF

UK

Paula Alves

ITQB-UNL

Av. República-EAN

2780-157 Oeiras

Portugal

and

IBET

Apartado 12

2781-901 Oeiras

Portugal

Wilfried A.M. Bakker

Intravacc – Institute for Translational Vaccinology

Antonie van Leeuwenhoeklaan 9

Bilthoven, 3721 MA

The Netherlands

P. Noel Barrett

Baxter Bioscience

Vaccine R&D

Uferstrasse 15

2304 Orth/Donau

Vienna

Austria

Peter Bergmann

Environmental Biotechnology and Bioprocess Engineering

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!

Lesen Sie weiter in der vollständigen Ausgabe!