Verfügbarkeit: Biotechnology

Biotechnology: a comprehensive training guide for the biotechnology industry

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Hauptverfasser:	Haider, Syed Imtiaz (VerfasserIn), Ashok, Anika (VerfasserIn)
Format:	Buch
Sprache:	English
Veröffentlicht:	Boca Raton, FL [u.a.] CRC 2009
Schlagworte:	Biotechnology / Study and teaching Biotechnology > Study and teaching Biotechnologie Aufgabensammlung
Online-Zugang:	Inhaltsverzeichnis
Beschreibung:	XXXIII, 834 S. 1 CD-ROM (12 cm)
ISBN:	9781420084481

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Datensatz im Suchindex

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adam_text	Contents About the Book ...................................................................................................................... xix Preface .................................................................................................................................. xxiii Acknowledgments ............................................................................................................. xxvii Authors ................................................................................................................................... xxix Introduction ........................................................................................................................... xxxi Disclaimer ............................................................................................................................ xxxiii Section I Microbial Growth ..................................1 Bio/T-OOl Microbial Growth Text ...................................................................................... 3 Microbial Nutrition .............................................................................................................. 4 Conditions Required for Optimum Growth .................................................................... 4 Physical Requirements ........................................................................................................ 4 Chemical Requirements ...................................................................................................... 5 Phases of Bacterial Growth ................................................................................................ 5 Control of Microbial Growth ............................................................................................. 7 Heat Generation by Microbial Growth ............................................................................. 7 Bio/T-OOl.l Microbial Growth Summary ............................................................................ 9 Віо/Т-ООЇ.г Microbial Growth Test Paper ......................................................................... 11 Bio/T-001.3 Microbial Growth Test Paper Answers ........................................................ 15 Section II Culturing Microorganisms ........................21 Bio/T-002 Culturing Microorganisms Text .................................................................... 23 Kinds of Media for Culturing Microorganisms ............................................................ 24 Isolating Pure Cultures ..................................................................................................... 25 vii Contents Methods of Preserving Cultures ..................................................................................... 25 The Morphology of the Colony ........................................................................................ 26 Light Transmission by the Colony .................................................................................. 26 Bio/T-002.1 Culturing Microorganisms Summary ......................................................... 27 Bio/T-002.2 Culturing Microorganisms Test Paper ......................................................... 29 Bio/T-002.3 Culturing Microorganisms Test Paper Answers ........................................ 33 Section III Bioreactor Configurations ........................39 Bio/T-003 Bioreactor Configurations Text ...................................................................... 41 Factors to Be Considered When Choosing the Method of Cultivation ...................... 42 Modifications Possible in Batch and Continuous Reactors .......................................... 42 Віо/Т-ООЗ.І Bioreactor Configurations Summary ............................................................ 45 Віо/Т-ООЗ.г Bioreactor Configurations Test Paper ........................................................... 47 Bio/T-003.3 Bioreactor Configurations Test Paper Answers .......................................... 51 Section IV Bioreactor Design Features .......................57 Bio/T-004 Bioreactor Design Features Text .................................................................... 59 Types of Bioreactors ........................................................................................................... 60 Bioreactors Used for Animal Cell Cultures ................................................................... 60 Bioreactors Used for Plant Cells ...................................................................................... 61 Bio/T-004.1 Bioreactor Design Features Summary .......................................................... 63 Bio/T-004.2 Bioreactor Design Features Test Paper ......................................................... 65 Bio/T-004.3 Bioreactor Design Features Test Paper Answers ........................................ 69 Section V Lyophilization: Growing with Biotechnology ........75 77 Bio/T-005 Lyophilization: Growing with Biotechnology Text .............................. Integrated Lyophilization: Balance between Cooling and Drying ............................ 79 Freezing .......................................................................................................................... 79 Primary Drying ............................................................................................................. 79 Secondary Drying ......................................................................................................... 80 Supercooling .................................................................................................................. 81 Pressure Control and Heat Transfer during Lyophilization ................................... 81 Contents ix Thermal Conductivity: The Key to Successful Lyophilization ................................... 81 Lyophilization Equipment: Advancing the Process ..................................................... 82 Lyophilization versus Conventional Drying ................................................................. 82 Bio/T-OOS.l Lyophilization: Growing with Biotechnology Summary ........................ 83 Freezing ............................................................................................................................... 84 Primary Drying .................................................................................................................. 84 Secondary Drying .............................................................................................................. 84 Supercooling ....................................................................................................................... 84 Thermal Conductivity ....................................................................................................... 85 Lyophilization Equipment ................................................................................................ 85 Lyophilization versus Conventional Drying ................................................................. 85 Bio/T-005.2 Lyophilization: Growing with Biotechnology Test Paper ....................... 87 Bio/T-005.3 Lyophilization: Growing with Biotechnology Test Paper Answers .......................................................................................... 91 Section VI Shear Effects in Culture .........................95 Bio/T-006 Shear Effects in Culture Text ......................................................................... 97 Introduction ........................................................................................................................ 97 Causes of Shear Force ........................................................................................................ 98 Quantifying Shear Force ................................................................................................... 98 Parameters Detected .......................................................................................................... 98 Data Collected .................................................................................................................... 99 Units of Shear Force ........................................................................................................... 99 Reduction in Shear Force .................................................................................................. 99 Віо/Т-ООб.і Shear Effects in Culture Summary ............................................................. 101 Bio/T-006.2 Shear Effects in Culture Test Paper ............................................................ 103 Bio/T-006.3 Shear Effects in Culture Test Paper Answers ........................................... 107 Section VII Energy Input in Bioreactors .....................113 Bio/T-007 Energy Input in Bioreactors Text ................................................................. 115 Classifications of Bioreactors Based on Energy Input ................................................ 116 Bio/T-007.1 Energy Input in Bioreactors Summary ...................................................... 119 Bio/T-007.2 Energy Input in Bioreactors Test Paper ...................................................... 121 Bio/T-007.3 Energy Input in Bioreactors Test Paper Answers .................................... 125 x Contents Section VIII Downstream Processing .......................131 Bio/T-008 Downstream Processing Text ....................................................................... 133 Centrifugation .................................................................................................................. 134 Filtration ............................................................................................................................ 134 Disintegration of Cells .................................................................................................... 134 Separation of Soluble Particles ....................................................................................... 135 Purification of the Separated Components .................................................................. 136 Bio/T-OOe.l Downstream Processing Summary ............................................................ 137 Bio/T-008.2 Downstream Processing Test Paper ............................................................ 139 Bio/T-008.3 Downstream Processing Test Paper Answers .......................................... 143 Section IX Mammalian Cell Cultures .......................149 Bio/T-009 Mammalian Cell Cultures Text ................................................................... 151 Types of Cells in Culture ................................................................................................ 152 Media and Growth Requirements ................................................................................. 152 Methods of Culturing Cells ............................................................................................ 153 Bio/T-Otm Mammalian Cell Cultures Summary ......................................................... 155 Bio/T-009.2 Mammalian Cell Cultures Test Paper ........................................................ 157 Bio/T-009.3 Mammalian Cell Cultures Test Paper Answers ....................................... 161 Section X Plant Cell Cultures ..............................167 Bio/T-010 Plant Cell Cultures Text ................................................................................ 169 Media for Plant Cell Cultures ........................................................................................ 170 Media Components ......................................................................................................... 171 Plant Cell Culture Systems ............................................................................................. 173 Safety Aspects of Plant Cell Culture ............................................................................. 174 Applications of Plant Cell Culture ................................................................................ 174 Bio/T-OlO.l Plant Cell Cultures Summary ...................................................................... 175 Bio/T-OlO.Z Plant Cell Cultures Test Paper ..................................................................... 177 Bio/T-010.3 Plant Cell Cultures Test Paper Answers .................................................... 181 Contents xi Section XI Fermentation ..................................187 Bio/T-Oll Fermentation Text ........................................................................................... 189 Mode of Operation of Fermentation Processes ........................................................... 190 Media for Industrial Fermentations .............................................................................. 191 Components of a Fermenter ........................................................................................... 191 Types of Fermenters ........................................................................................................ 193 Bio/T-Oll.l Fermentation Summary ................................................................................. 195 Bio/T-011.2 Fermentation Test Paper ................................................................................ 197 Віо/Т-ОП.З Fermentation Test Paper Answers ............................................................... 201 Section XII Characteristics of Cells in Culture ...............207 Bio/T-012 Characteristics of Cells in Culture Text ..................................................... 209 Primary Culture ............................................................................................................... 209 Cell Types .......................................................................................................................... 210 Selection of Particular Cell Types .................................................................................. 211 Duration of Primary Cell Survival ................................................................................ 211 Normal Cells ..................................................................................................................... 211 Anchorage Dependence .................................................................................................. 212 Cellular Differentiation ................................................................................................... 212 Transformed Cells ............................................................................................................ 213 Cell Culture Collections .................................................................................................. 213 Cell Storage ....................................................................................................................... 214 Віо/Т-Оіг.і Characteristics of Cells in Culture Summary .......................................... 215 Bio/T-012.2 Characteristics of Cells in Culture Test Paper .......................................... 217 Bio/T-012.3 Characteristics of Cells in Culture Test Paper Answers ................................................................................................. 221 Section XIII Cell Lysis ....................................227 Bio/T-013 Cell Lysis Text ................................................................................................. 229 Methods of Cell Lysis ...................................................................................................... 230 Mechanical Methods .................................................................................................. 230 Nonmechanical Methods ........................................................................................... 231 Віо/Т-ОІЗ.І Cell Lysis Summary ....................................................................................... 233 xii Contents Bio/T-013.2 Cell Lysis Test Paper ...................................................................................... 235 Bio/T-013.3 Cell Lysis Test Paper Answers ..................................................................... 239 Section XIV Cells Fractionation ............................245 Bio/T-014 Cells Fractionation Text ................................................................................. 247 Steps Involved in the Process of Cell Fractionation .................................................... 248 Bio/T-OM.l Cells Fractionation Summary ...................................................................... 251 Bio/T-014.2 Cells Fractionation Test Paper ...................................................................... 253 Bio/T-014.3 Cells Fractionation Test Paper Answers .................................................... 257 Section XV Centrifugation ................................263 Bio/T-015 Centrifugation Text ........................................................................................ 265 Centrifuges ....................................................................................................................... 267 Types of Rotors ................................................................................................................. 268 Safety Aspects of Centrifugation ................................................................................... 268 Bio/T-OlS.l Centrifugation Summary .............................................................................. 269 Bio/T-015.2 Centrifugation Test Papers ........................................................................... 271 Bio/T-015.3 Centrifugation Test Paper Answers ............................................................ 275 Section XVI Homogenization ..............................281 Bio/T-016 Homogenization Text ..................................................................................... 283 Methods of Homogenization ......................................................................................... 284 Віо/Т-Оіб.і Homogenization Summary .......................................................................... 287 Bio/T-016.2 Homogenization Test Paper .......................................................................... 289 Bio/T-016.3 Homogenization Test Paper Answers ........................................................ 293 Section XVII Refolding of Inclusion Bodies .................299 Bio/T-OIľ Refolding of Inclusion Bodies Text ............................................................ 301 Refolding of Inclusion Bodies ........................................................................................ 302 Methods of Refolding ...................................................................................................... 302 Contents xiii Factors Determining the Refolding Process ................................................................ 303 Additives to the Dilution Buffer .................................................................................... 303 Bio/T-017.1 Refolding of Inclusion Bodies Summary .................................................. 305 Bio/T-017.2 Refolding of Inclusion Bodies Test Paper ................................................. 307 Bio/T-017.3 Refolding of Inclusion Bodies Test Paper Answers ................................ 311 Section XVIII Solubilization and Refolding of Proteins .......317 Bio/T-018 Solubilization and Refolding of Proteins Text ......................................... 319 Solubilization of Proteins ................................................................................................ 320 Detection of Solubilization ............................................................................................. 320 Refolding ........................................................................................................................... 321 Methods of Refolding ...................................................................................................... 321 Analysis and Purification of Refolded Proteins .......................................................... 322 Applications ...................................................................................................................... 322 Bio/T-Oie.l Solubilization and Refolding of Proteins Summary .............................. 323 Віо/Т-Оіб.г Solubilization and Refolding of Proteins Test Paper .............................. 325 Bio/T-018.3 Solubilization and Refolding of Proteins Test Paper Answers ........................................................................................ 329 Section XIX Inclusion Bodies Solubilization .................335 Bio/T-019 Inclusion Bodies Solubilization Text ......................................................... 337 Solubilization Buffer Constituents ............................................................................... 338 Procedure of Isolation and Solubilization .................................................................... 339 Bio/T-OlW Inclusion Bodies Solubilization Summary ............................................... 341 Bio/T-019.2 Inclusion Bodies Solubilization Test Paper .............................................. 343 Віо/Т-ОЖЗ Inclusion Bodies Solubilization Test Paper Answers ............................. 347 Section XX Sludge Treatment ..............................353 Bio/T-020 Sludge Treatment Text ................................................................................... 355 Types of Sludge ................................................................................................................ 356 Stages of Sludge Treatment ............................................................................................. 357 BiofJ-OW.l Sludge Treatment Summary ......................................................................... 359 xjv Contents Bio/T-020.2 Sludge Treatment Test Paper ........................................................................ 361 Bio/T-020.3 Sludge Treatment Test Paper Answers ....................................................... 365 Section XXI Freeze Drying ................................371 Bio/T-021 Freeze Drying Text ......................................................................................... 373 Stages of Freeze Drying .................................................................................................. 374 Advantages of Freeze Drying ........................................................................................ 375 Disadvantages of Freeze Drying ................................................................................... 375 Types of Freeze-Drying Equipment ............................................................................. 375 Applications of Freeze Drying ....................................................................................... 376 Bio/T-021.1 Freeze Drying Summary ............................................................................... 377 Bio/T-021.2 Freeze Drying Test Paper .............................................................................. 379 Bio/T-021.3 Freeze Drying Test Paper Answers ............................................................. 383 Section XXII Vacuum Drying ..............................389 Bio/T-022 Vacuum Drying Text ...................................................................................... 391 Types of Vacuum Dryers ................................................................................................. 392 Advantages of Vacuum Drying ..................................................................................... 392 Disadvantages of Vacuum Drying ................................................................................ 393 Applications of Vacuum Drying .................................................................................... 393 Bio/T-022.1 Vacuum Drying Summary ............................................................................ 395 Bio/T-022.2 Vacuum Drying Test Paper ........................................................................... 397 Bio/T-022.3 Vacuum Drying Test Paper Answers .......................................................... 401 Section XXIII Diafiltration................................407 Bio/T-023 Diafiltration Text ............................................................................................. 409 Ways to Perform Diafiltration ........................................................................................ 410 Factors Affecting the Performance of Ultrafiltration .................................................. 411 Advantages of Diafiltration ............................................................................................ 411 Applications of Diafiltration ........................................................................................... 4Н Віо/Т-023.1 Diafiltration Summary .................................................................................. 413 Віо/Т-023.2 Diafiltration Test Paper ................................................................................. 415 Bio/T-023.3 Diafiltration Test Paper Answers ................................................................ 419 Contents xv Section XXIV Partition Chromatographs ....................425 Bio/T-024 Partition Chromatographs Text ................................................................... 427 Subtypes of Partition Chromatography ....................................................................... 428 Advantages of Partition Chromatography ................................................................... 429 Applications of Partition Chromatography ................................................................. 430 Bio/T-024.1 Partition Chromatographs Summary ......................................................... 431 Bio/T-024.2 Partition Chromatographs Test Paper ........................................................ 433 Bio/T-024.3 Partition Chromatographs Test Paper Answers ....................................... 437 Section XXV Adsorption Chromatographs ...................443 Bio/T-025 Adsorption Chromatographs Text .............................................................. 445 Parts of a Column Adsorption Chromatograph .......................................................... 446 Forces of Attraction ......................................................................................................... 446 Choice of Adsorbent ........................................................................................................ 446 Choice of Solvent .............................................................................................................. 447 Thin Layer Chromatography ......................................................................................... 447 Expanded Bed Adsorption ............................................................................................. 448 Bio/T-025.1 Adsorption Chromatographs Summary .................................................... 449 Bio/T-025.2 Adsorption Chromatographs Test Paper ................................................... 451 Bio/T-025.3 Adsorption Chromatographs Test Paper Answers .................................. 455 Section XXVI Gel Filtration Chromatographs ................461 Bio/T-026 Gel Filtration Chromatographs Text ........................................................... 463 Parts of the Chromatograph ........................................................................................... 464 Applications of Gel Filtration Chromatography ......................................................... 465 Bio/T-026.1 Gel Filtration Chromatographs Summary ................................................ 467 Bio/T-026.2 Gel Filtration Chromatographs Test Paper ................................................ 469 Bio/T-026.3 Gel Filtration Chromatographs Test Paper Answers .............................. 473 Section XXVII Techniques of Genetic Engineering ...........479 Bio/T-027 Techniques of Genetic Engineering Text .................................................. 481 Outline of Gene Cloning ................................................................................................. 481 Procedures for Gene Cloning ......................................................................................... 481 xvi Contents Plasmid Vectors ................................................................................................................ 482 Restriction Endonuclease ................................................................................................ 482 Isolation of DNA to Be Cloned ....................................................................................... 483 Plasmid Cloning Vector ............................................................................................. 483 Joining DNA ................................................................................................................ 484 Transformation and Growth of Cells ....................................................................... 485 Selection of Clones ...................................................................................................... 485 Colony Hybridization ............................................................................................ 485 Viral DNA and Cosmid Vectors ................................................................................ 486 Gene Expression .......................................................................................................... 486 Genetic Manipulation of Eukaryotic Cells .............................................................. 487 Plant Cells ................................................................................................................ 487 Mammalian Cells ................................................................................................... 487 Yeast ......................................................................................................................... 488 Site-Directed Mutagenesis .............................................................................................. 488 Bio/T-027.1 Techniques of Genetic Engineering Summary ........................................ 489 Bio/T-027.2 Techniques of Genetic Engineering Test Paper ....................................... 491 Bio/T-027.3 Techniques of Genetic Engineering Test Paper Answers ........................................................................................ 497 Section XXVIII Industrial Biosafety ........................503 Bio/T-028 Industrial Biosafety Text ............................................................................... 505 Premises ............................................................................................................................ 505 Storage Facilities ............................................................................................................... 506 Sanitation and Staff Facilities ......................................................................................... 506 Heating and Ventilation ................................................................................................. 506 Lighting ............................................................................................................................. 506 Services .............................................................................................................................. 507 Laboratory Biosecurity .................................................................................................... 507 Fire Prevention and Fire Protection .............................................................................. 507 Flammable Liquid Storage .............................................................................................. 508 Compressed and Liquefied Gases ................................................................................. 508 Electrical Hazards ............................................................................................................ 508 Personal Protection .......................................................................................................... 509 Health and Safety of Staff ............................................................................................... 509 Laboratory Equipment .................................................................................................... 509 Infectious Materials ......................................................................................................... 510 Chemicals and Radioactive Substances ........................................................................ 510 Bio/T-028.1 Industrial Biosafety Summary .................................................................... 511 Bio/T-028.2 Industrial Biosafety Test Paper .................................................................... 513 Contents xvii Bio/T-028.3 Industrial Biosafety Test Paper Answers .................................................. 523 Bio/T-029 Certificate of Attainment .............................................................................. 535 Bio/T-030 Biotechnology Training Records ................................................................. 537 Appendices .............................................539 Appendix A ICH Harmonised Tripartite Guideline ................................................... 541 A.I Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products ...................... 543 A. 2 Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process ............................................................................... 561 A.3 Quality of Biotechnology Products: Stability Testing of Biotechnology/Biological Products ...................................................... 577 A.4 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin ........................................ 589 A.5 Specification: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products ................................................ 621 A.6 Preclinical Safety Evaluation of Biotechnology- Derived Pharmaceuticals ............................................................................ 643 Appendix В Guidance for Industry by U.S. Department of Health and Human Services — Food and Drug Administration — Center for Biologies Evaluation and Research (CBER)—February 1999 ................................ 657 B.I Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma- or Serum-Derived Products ......................................... 659 B.2 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993) ............................................................ 679 Appendix С ЕМЕА European Medicine Agency Guideline ...................................... 723 C.I Guideline on Virus Safety Evaluation of Biotechnology Investigation Medicinal Products ............................................................. 725 xviii Contents C.2 Guideline on the Chemical and Pharmaceutical Quality Documentation Concerning Biological Investigation Medicinal Products in Clinical Trials ...................................................... 735 C.3 Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues ........................................................................... 739 C.4 Guideline on Similar Biological Medicinal Products ........................... 749 C.5 Note for Guidance on Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process ........................... 757 C.6 Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues ................................................................................................ 771 C.7 Development Pharmaceutics for Biotechnological and Biological Products (Annex to Note for Guidance on Development Pharmaceutics) ..................................................................... 783 C.8 Concept Paper on the Development of a Guideline on Viral Safety Evaluation of Biotechnological Products to Be Used in Clinical Trials ........................................................................................... 789 C.9 Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues Guideline on Similar Medicinal Products Containing Recombinant Erythropoietins ............................ 793 Recommended Reading ......................................................................................................... 833
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spelling	Haider, Syed Imtiaz Verfasser aut Biotechnology a comprehensive training guide for the biotechnology industry Syed Imtiaz Haider, Anika Ashok Boca Raton, FL [u.a.] CRC 2009 XXXIII, 834 S. 1 CD-ROM (12 cm) txt rdacontent n rdamedia nc rdacarrier Biotechnology / Study and teaching Biotechnology Study and teaching Biotechnologie (DE-588)4069491-4 gnd rswk-swf (DE-588)4143389-0 Aufgabensammlung gnd-content Biotechnologie (DE-588)4069491-4 s DE-604 Ashok, Anika Verfasser aut Digitalisierung UB Bayreuth application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017097142&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis
spellingShingle	Haider, Syed Imtiaz Ashok, Anika Biotechnology a comprehensive training guide for the biotechnology industry Biotechnology / Study and teaching Biotechnology Study and teaching Biotechnologie (DE-588)4069491-4 gnd
subject_GND	(DE-588)4069491-4 (DE-588)4143389-0
title	Biotechnology a comprehensive training guide for the biotechnology industry
title_auth	Biotechnology a comprehensive training guide for the biotechnology industry
title_exact_search	Biotechnology a comprehensive training guide for the biotechnology industry
title_full	Biotechnology a comprehensive training guide for the biotechnology industry Syed Imtiaz Haider, Anika Ashok
title_fullStr	Biotechnology a comprehensive training guide for the biotechnology industry Syed Imtiaz Haider, Anika Ashok
title_full_unstemmed	Biotechnology a comprehensive training guide for the biotechnology industry Syed Imtiaz Haider, Anika Ashok
title_short	Biotechnology
title_sort	biotechnology a comprehensive training guide for the biotechnology industry
title_sub	a comprehensive training guide for the biotechnology industry
topic	Biotechnology / Study and teaching Biotechnology Study and teaching Biotechnologie (DE-588)4069491-4 gnd
topic_facet	Biotechnology / Study and teaching Biotechnology Study and teaching Biotechnologie Aufgabensammlung
url	http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017097142&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
work_keys_str_mv	AT haidersyedimtiaz biotechnologyacomprehensivetrainingguideforthebiotechnologyindustry AT ashokanika biotechnologyacomprehensivetrainingguideforthebiotechnologyindustry

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