DownstreamProcessingofBioengineering生物工程下游技术杨志红yangzhihong@hutc.zj.cn691612SectionOnePreface•Considerableeffortandtimeisallocatedtointroducingcellcultureandfermentationtechnologytoundergraduatestudentsinacademia,generallythrougharangeofcoursesinindustrialbiotechnologyandrelateddisciplines.Similarly,alargenumberoftextbooksareavailabletodescribetheapplicationsofthesetechnologiesinindustry.•However,therehasbeenagenerallackofappreciationofthesignificantdevelopmentsindownstreamprocessingandisolationtechnology,theneedforwhichislargelydrivenbythestringentregulatoryrequirementsforpurityandqualityofinjectablebiopharmaceuticals.Thisisparticularlyreflectedbythegeneralabsenceofcoverageofthissubjectinmanybiotechnologyandrelatedcoursesineducationalinstitutions.•ForaconsiderablewhileIhavefeltthatthereisincreasingneedforanintroductorytexttovariousaspectsofdownstreamprocessing,particularlywithrespecttotheneedsofthebiopharmaceuticalandbiotechnologyindustry.Althoughtherearenumeroustextsthatcovervariousaspectsofproteinpurificationtechniquesinisolation,thereisaneedforaworkthatcoversthebroadrangeofisolationtechnologyinanindustrialsetting.•ItisanticipatedthatDownstreamProcessingofProteins:MethodsandProtocolswillplayasmallpartinfillingthisgapandthusproveausefulcontributiontothefield.Itisalsodesignedtoencourageeducationalstrategiststobroadenthecoverageofthesetopicsinindustrialbiotechnologycoursesbyincludingaccountsofthisimportantandrapidlydevelopingelementoftheindustrialprocess.•Thehopeisthatthiswillresultingraduateshavingareasonableunderstandingofdownstreamprocessingprinciplesandtechniques,andthusbebetterpreparedtofulfilltheever-increasingdemandforcompetentisolationscientistsinindustries.•Thisis,ofcourse,achievedwiththehelpofthededicatedcontributingauthorsofDownstreamProcessingofProteins:MethodsandProtocols,withoutwhosewillingnesstocontributeandpatienceitwouldnothavebeenpossible.IwouldalsoliketothanktheHumanaPressandProf.JohnWalker(theserieseditor)fortheirencouragementandpromptfeedback.•MythanksarealsoduetotheMedevaPharmaDevelopmentmanagementforprovidingmewiththetimeandopportunitytofulfillthistask,andwithoutwhosesupportitwouldhavebeenimpossible.Finally,Iwishtothankmywife,children,andfamilymembersforallowingmetoperseverewithmyeditingactivitiesinperhapswhatshouldhavebeentheirtime.SectionTwo菌种筛选摇瓶实验发酵罐实验IndustrialScaleup•Totransferthepilotscaleresultsintoacommerciallyfeasibleproductionsetting.•Fermentorsizesrangefrom100Lto500,000L,dependingonproducts.在疾病治疗方面的应用生物制药抗生素基因治疗生物工程研究领域微生物培养动物细胞培养植物细胞培养天然资源生化材料海洋生物培养生物工程产业领域生物制药（抗生素，基因重组蛋白，氨基酸，疫苗，菌苗，天然药物，生化药物，血液制品，抗体，多糖，多肽）生物化工（乳酸，柠檬酸，苹果酸，丙烯酸，甘油，异丙醇，乙烯）生物能源（甲醇，乙醇，生物柴油，生物汽油）生物材料（明胶，胶原蛋白，人造皮肤，人造骨，人造脏器）生物医学（诊断试剂，基因治疗，人及生物克隆）环境生物（环境治理，水污染，土壤污染，风沙治理）生物食品（醋，啤酒业，酿酒，乳制品，奶制品）生物资源（动物，植物，微生物）生物农业（基因食品，基因植物）生物工程的上中下游上游：菌种，基因工程，分子生物学，遗传学中游：微生物发酵工程，动植物细胞，海洋生物培养下游：生物分离工程生物产品特点①产物浓度低的水溶液原因：a.氧传递限制；b.细胞量;c.产物抑制②组分复杂a....
