Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry

Cover Page......Page 1
Title: Biotechnology: A Comprehensive Training Guide for the Biotecnology Industry......Page 3
ISBN 9781420084481......Page 4
Dedication\r......Page 5
Contents......Page 6
About the Book......Page 18
Preface......Page 22
Acknowledgments......Page 26
Authors......Page 27
Introduction......Page 29
Disclaimer......Page 31
Section I Microbial Growth......Page 32
Bio/ T- 001 Microbial Growth Text......Page 34
Physical Requirements......Page 35
Phases of Bacterial Growth......Page 36
Heat Generation by Microbial Growth......Page 38
Bio/ T- 001.1 Microbial Growth Summary......Page 40
Bio/ T- 001.2 Microbial Growth Test Paper......Page 42
Bio/ T- 001.3 Microbial Growth Test Paper Answers......Page 46
Section II Cultural Microorganisms......Page 52
Bio/ T- 002 Culturing Microorganisms Text......Page 54
Kinds of Media for Culturing Microorganisms......Page 55
Methods of Preserving Cultures......Page 56
Light Transmission by the Colony......Page 57
Bio/ T- 002.1 Culturing Microorganisms Summary......Page 58
Bio/ T- 002.2 Culturing Microorganisms Test Paper......Page 60
Bio/ T- 002.3 Culturing Microorganisms Test Paper Answers......Page 64
Section III Bioreactor Configurations......Page 70
Bio/ T- 003 Bioreactor Configurations Text......Page 72
Modifications Possible in Batch and Continuous Reactors......Page 73
Bio/ T- 003.1 Bioreactor Configurations Summary......Page 76
Bio/ T- 003.2 Bioreactor Configurations Test Paper......Page 78
Bio/ T- 003.3 Bioreactor Configurations Test Paper Answers......Page 82
Section IV Bioreactor Design Features......Page 88
Bio/ T- 004 Bioreactor Design Features Text......Page 90
Bioreactors Used for Animal Cell Cultures......Page 91
Bioreactors Used for Plant Cells......Page 92
Bio/ T- 004.1 Bioreactor Design Features Summary......Page 94
Bio/ T- 004.2 Bioreactor Design Features Test Paper......Page 96
Bio/ T- 004.3 Bioreactor Design Features Test Paper Answers......Page 100
Section V Lyophilization: Growingwith Biotechnology......Page 106
Bio/ T- 005 Lyophilization: Growing with Biotechnology Text......Page 108
Integrated Lyophilization: Balance between Cooling and Drying......Page 110
Thermal Conductivity: The Key to Successful Lyophilization......Page 112
Lyophilization versus Conventional Drying......Page 113
Bio/ T- 005.1 Lyophilization: Growing with Biotechnology Summary......Page 114
Supercooling......Page 115
Lyophilization versus Conventional Drying......Page 116
Bio/ T- 005.2 Lyophilization: Growing with Biotechnology Test Paper......Page 118
Bio/ T- 005.3 Lyophilization: Growing with Biotechnology Test Paper Answers......Page 122
Section VI Shear Effects in Culture......Page 126
Introduction......Page 128
Parameters Detected......Page 129
Reduction in Shear Force......Page 130
Bio/ T- 006.1 Shear Effects in Culture Summary......Page 132
Bio/ T- 006.2 Shear Effects in Culture Test Paper......Page 134
Bio/ T- 006.3 Shear Effects in Culture Test Paper Answers......Page 138
Section VII Energy Input in Bioreactors......Page 144
Bio/ T- 007 Energy Input in Bioreactors Text......Page 146
Classifications of Bioreactors Based on Energy Input......Page 147
Bio/ T- 007.1 Energy Input in Bioreactors Summary......Page 150
Bio/ T- 007.2 Energy Input in Bioreactors Test Paper......Page 152
Bio/ T- 007.3 Energy Input in Bioreactors Test Paper Answers......Page 156
Section VIII Downstream Processing......Page 162
Bio/ T- 008 Downstream Processing Text......Page 164
Disintegration of Cells......Page 165
Separation of Soluble Particles......Page 166
Purification of the Separated Components......Page 167
Bio/ T- 008.1 Downstream Processing Summary......Page 168
Bio/ T- 008.2 Downstream Processing Test Paper......Page 170
Bio/ T- 008.3 Downstream Processing Test Paper Answers......Page 174
Section IX Mammalian Cell Cultures......Page 180
Bio/ T- 009 Mammalian Cell Cultures Text......Page 182
Media and Growth Requirements......Page 183
Methods of Culturing Cells......Page 184
Bio/ T- 009.1 Mammalian Cell Cultures Summary......Page 186
Bio/ T- 009.2 Mammalian Cell Cultures Test Paper......Page 188
Bio/ T- 009.3 Mammalian Cell Cultures Test Paper Answers......Page 192
Section X Plant Cell Cultures......Page 198
Bio/ T- 010 Plant Cell Cultures Text......Page 200
Media for Plant Cell Cultures......Page 201
Media Components......Page 202
Plant Cell Culture Systems......Page 204
Applications of Plant Cell Culture......Page 205
Bio/ T- 010.1 Plant Cell Cultures Summary......Page 206
Bio/ T- 010.2 Plant Cell Cultures Test Paper......Page 208
Bio/ T- 010.3 Plant Cell Cultures Test Paper Answers......Page 212
Section XI Fermentation......Page 218
Bio/ T- 011 Fermentation Text......Page 220
The Mode of Operation of Fermentation Processes......Page 221
The Components of a Fermenter......Page 222
Types of Fermenters......Page 224
Bio/ T- 011.1 Fermentation Summary......Page 226
Bio/ T- 011.2 Fermentation Test Paper......Page 228
Bio/ T- 011.3 Fermentation Test Paper Answers......Page 232
Section XII Characteristics of Cells in Culture......Page 238
Primary Culture......Page 240
Cell Types......Page 241
Normal Cells......Page 242
Cellular Differentiation......Page 243
Cell Culture Collections......Page 244
Cell Storage......Page 245
Bio/ T- 012.1 Characteristics of Cells in Culture Summary......Page 246
Bio/ T- 012.2 Characteristics of Cells in Culture Test Paper......Page 248
Bio/ T- 012.3 Characteristics of Cells in Culture Test Paper Answers......Page 252
Section XIII Cell Lysis......Page 258
Bio/ T- 013 Cell Lysis Text......Page 260
Methods of Cell Lysis......Page 261
Bio/ T- 013.1 Cell Lysis Summary......Page 264
Bio/ T- 013.2 Cell Lysis Test Paper......Page 266
Bio/ T- 013.3 Cell Lysis Test Paper Answers......Page 270
Section XIV Cells Fractionation......Page 276
Bio/ T- 014 Cells Fractionation Text......Page 278
Steps Involved in the Process of Cell Fractionation......Page 279
Bio/ T- 014.1 Cells Fractionation Summary......Page 282
Bio/ T- 014.2 Cells Fractionation Test Paper......Page 284
Bio/ T- 014.3 Cells Fractionation Test Paper Answers......Page 288
Section XV Centrifugation......Page 294
Bio/ T- 015 Centrifugation Text......Page 296
Centrifuges......Page 298
Safety Aspects of Centrifugation......Page 299
Bio/ T- 015.1 Centrifugation Summary......Page 300
Bio/ T- 015.2 Centrifugation Test Papers......Page 302
Bio/ T- 015.3 Centrifugation Test Paper Answers......Page 306
Section XVI Homogenization......Page 312
Bio/ T- 016 Homogenization Text......Page 314
Methods of Homogenization......Page 315
Bio/ T- 016.1 Homogenization Summary......Page 318
Bio/ T- 016.2 Homogenization Test Paper......Page 320
Bio/ T- 016.3 Homogenization Test Paper Answers......Page 324
Section XVII Refolding of Inclusion Bodies......Page 330
Bio/ T- 017 Refolding of Inclusion Bodies Text......Page 332
Methods of Refolding......Page 333
Additives to the Dilution Buffer......Page 334
Bio/ T- 017.1 Refolding of Inclusion Bodies Summary......Page 336
Bio/ T- 017.2 Refolding of Inclusion Bodies Test Paper......Page 338
Bio/ T- 017.3 Refolding of Inclusion Bodies Test Paper Answers......Page 342
Section XVIII Solubilization and Refolding of Proteins......Page 348
Bio/ T- 018 Solubilization and Refolding of Proteins Text......Page 350
Detection of Solubilization......Page 351
Methods of Refolding......Page 352
Applications......Page 353
Bio/ T- 018.1 Solubilization and Refolding of Proteins Summary......Page 354
Bio/ T- 018.2 Solubilization and Refolding of Proteins Test Paper......Page 356
Bio/ T- 018.3 Solubilization and Refolding of Proteins Test\rPaper Answers......Page 360
Section XIX Inclusion Bodies Solubilization......Page 366
Bio/ T- 019 Inclusion Bodies Solubilization Text......Page 368
Solubilization Buffer Constituents......Page 369
Procedure of Isolation and Solubilization......Page 370
Bio/ T- 019.1 Inclusion Bodies Solubilization Summary......Page 372
Bio/ T- 019.2 Inclusion Bodies Solubilization Test Paper......Page 374
Bio/ T- 019.3 Inclusion Bodies Solubilization Test Paper Answers......Page 378
Section XX Sludge Treatment......Page 384
Bio/ T- 020 Sludge Treatment Text......Page 386
Types of Sludge......Page 387
Stages of Sludge Treatment......Page 388
Bio/ T- 020.1 Sludge Treatment Summary......Page 390
Bio/ T- 020.2 Sludge Treatment Test Paper......Page 392
Bio/ T- 020.3 Sludge Treatment Test Paper Answers......Page 396
Section XXI Freeze Drying......Page 402
Bio/ T- 021 Freeze Drying Text......Page 404
Stages of Freeze Drying......Page 405
Types of Freeze- Drying Equipment......Page 406
Applications of Freeze Drying......Page 407
Bio/ T- 021.1 Freeze Drying Summary......Page 408
Bio/ T- 021.2 Freeze Drying Test Paper......Page 410
Bio/ T- 021.3 Freeze Drying Test Paper Answers......Page 414
Section XXII Vacuum Drying......Page 420
Bio/ T- 022 Vacuum Drying Text......Page 422
Advantages of Vacuum Drying......Page 423
Applications of Vacuum Drying......Page 424
Bio/ T- 022.1 Vacuum Drying Summary......Page 426
Bio/ T- 022.2 Vacuum Drying Test Paper......Page 428
Bio/ T- 022.3 Vacuum Drying Test Paper Answers......Page 432
Section XXIII Diafiltration......Page 438
Bio/ T- 023 Diafiltration Text......Page 440
Ways to Perform Diafiltration......Page 441
Applications of Diafiltration......Page 442
Bio/ T- 023.1 Diafiltration Summary......Page 444
Bio/ T- 023.2 Diafiltration Test Paper......Page 446
Bio/ T- 023.3 Diafiltration Test Paper Answers......Page 450
Section XXIV Partition Chromatographs......Page 456
Bio/ T- 024 Partition Chromatographs Text......Page 458
Subtypes of Partition Chromatography......Page 459
Advantages of Partition Chromatography......Page 460
Applications of Partition Chromatography......Page 461
Bio/ T- 024.1 Partition Chromatographs Summary......Page 462
Bio/ T- 024.2 Partition Chromatographs Test Paper......Page 464
Bio/ T- 024.3 Partition Chromatographs Test Paper Answers......Page 468
Section XXV Adsorption Chromatographs......Page 474
Bio/ T- 025 Adsorption Chromatographs Text......Page 476
Choice of Adsorbent......Page 477
Thin Layer Chromatography......Page 478
Expanded Bed Adsorption......Page 479
Bio/ T- 025.1 Adsorption Chromatographs Summary......Page 480
Bio/ T- 025.2 Adsorption Chromatographs Test Paper......Page 482
Bio/ T- 025.3 Adsorption Chromatographs Test Paper Answers......Page 486
Section XXVI Gel Filtration Chromatographs......Page 492
Bio/ T- 026 Gel Filtration Chromatographs Text......Page 494
Parts of the Chromatograph......Page 495
Applications of Gel Filtration Chromatography......Page 496
Bio/ T- 026.1 Gel Filtration Chromatographs Summary......Page 498
Bio/ T- 026.2 Gel Filtration Chromatographs Test Paper......Page 500
Bio/ T- 026.3 Gel Filtration Chromatographs Test Paper Answers......Page 504
Section XXVII Techniques of Genetic Engineering......Page 510
Procedures for Gene Cloning......Page 512
Restriction Endonuclease......Page 513
Isolation of DNA to Be Cloned......Page 514
Site- Directed Mutagenesis......Page 519
Bio/ T- 027.1 Techniques of Genetic Engineering Summary......Page 520
Bio/ T- 027.2 Techniques of Genetic Engineering Test Paper......Page 522
Bio/ T- 027.3 Techniques of Genetic Engineering Test\rPaper Answers......Page 528
Section XXVIII Industrial Biosafety......Page 534
Premises......Page 536
Lighting......Page 537
Fire Prevention and Fire Protection......Page 538
Electrical Hazards......Page 539
Laboratory Equipment......Page 540
Chemicals and Radioactive Substances......Page 541
Bio/ T- 028.1 Industrial Biosafety Summary......Page 542
Bio/ T- 028.2 Industrial Biosafety Test Paper......Page 544
Bio/ T- 028.3 Industrial Biosafety Test Paper Answers......Page 554
Bio/ T- 029......Page 566
Bio/ T- 030 Biotechnology Training Records......Page 568
Appendices......Page 570
Appendix A: ICH Harmonised Tripartite Guideline......Page 572
Appendix A.1 Derivation and Characterisation of Cell Substrates\rUsed for Production of Biotechnological/Biological\rProducts......Page 574
Appendix A.2 Comparability of Biotechnological/Biological\rProducts Subject to Changes in Their\rManufacturing Process......Page 592
Appendix A.3 Quality of Biotechnology Products: Stability\rTesting of Biotechnology/Biological Products......Page 608
Appendix A.4 Viral Safety Evaluation of Biotechnology Products\rDerived from Cell Lines of Human or Animal Origin......Page 620
Appendix A.5 Specification: Test Procedures and Acceptance\rCriteria for Biotechnological/Biological Products......Page 652
Appendix A.6 Preclinical Safety Evaluation of Biotechnology-\rDerived Pharmaceuticals......Page 674
Appendix B: Guidance for Industry by U.S. Department ofHealth and Human Services—Food and DrugAdministration—Center for Biologics Evaluationand Research (CBER)—February 1999......Page 688
Appendix B.1 Guidance for Industry: For the Submission\rof Chemistry, Manufacturing and Controls\rand Establishment Description Information\rfor Human Plasma-Derived Biological Products,\rAnimal Plasma- or Serum-Derived Products......Page 690
Appendix B.2 Points to Consider in the Characterization of\rCell Lines Used to Produce Biologicals (1993)*......Page 710
Appendix C: EMEA European Medicine Agency Guideline......Page 754
Appendix C.1 Guideline on Virus Safety Evaluation\rof Biotechnology Investigation\rMedicinal Products......Page 756
Appendix C.2 Guideline on the Chemical and Pharmaceutical\rQuality Documentation Concerning Biological\rInvestigation Medicinal Products\rin Clinical Trials......Page 766
Appendix C.3 Guideline on Similar Biological Medicinal Products\rContaining Biotechnology-Derived Proteins as\rActive Substance: Quality Issues......Page 770
Appendix C.4 Guideline on Similar Biological Medicinal Products......Page 780
Appendix C.5 Note for Guidance on Biotechnological/Biological\rProducts Subject to Changes in Their\rManufacturing Process......Page 788
Appendix C.6 Guideline on Comparability of Medicinal Products\rContaining Biotechnology-Derived Proteins as\rActive Substance: Quality Issues......Page 802
Appendix C.7 Development Pharmaceutics for Biotechnological\rand Biological Products......Page 814
Appendix C.8 Concept Paper on the Development of a Guideline on\rViral Safety Evaluation of Biotechnological Products\rto Be Used in Clinical Trials......Page 820
Appendix C.9 Annex to Guideline on Similar Biological Medicinal\rProducts Containing Biotechnology-Derived Proteins\ras Active Substance: Non-Clinical and Clinical\rIssues Guideline on Similar Medicinal Products\rContaining Recombinant Erythropoietins......Page 824
Recommended Reading......Page 864