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1、Overview Laboratory of Bacterial PolysaccharidesFromcover-Science,23March,20012021/7/27 星期二1The Laboratory of Bacterial Polysaccharides ThemissionofthisLaboratoryisunifiedaroundthefactthat:Most all invasive bacterial diseases in the youngpediatric population are caused by bacterial specieshaving pol
2、ysaccharide capsules:Haemophilus influenzae Neisseria meningitidisStreptococcus pneumoniaeStreptococcus agalactiae(GroupBStrep)2021/7/27 星期二2Licensed Vaccines for which the LBP has Product ResponsibilityPolysaccharides:Pneumococcal23-valentMerckMeningococcal4-valentAventisPasteurTyphoidViAventisPast
3、eurConjugates:Haemophilusinfluenzaetypeb(Hib)WyethAventisPasteurMerck(2)Pneumococcal7-valentWyethCombination vaccines2021/7/27 星期二3Current Regulatory Activities in the Laboratory of Bacterial PolysaccharidesO IND supplement review over 125 active INDso Product License application and supplement revi
4、ew Over 80 submissions since June 2000o Meetings and conference calls with manufacturerso Lot release protocol review and lot release testing Approximately 400 protocols per yearo Assist in training of reviewers and inspectorso Participate in inspections of manufacturing facilitieso Presentations to
5、 VRBPAC2021/7/27 星期二4Major outside mission related activities by Laboratory of BacterialPolysaccharides Personnel v Temporary consultants to CDC,PAHO,WHO and PATHv Help draft WHO requirements for conjugate vaccinesv Review Red Book chapters on polysaccharide and conjugate vaccinesv Journal review mu
6、ltiple journalsv Grant review for Meningitis Research Foundationv Review of Military Infectious Disease Research Programv On organizing committees for major workshopsv Consult/train foreign laboratories in Quality Control2021/7/27 星期二5Research in the Laboratory of Bacterial Polysaccharides TheLBPisr
7、esponsiblefor:Conductingbasicandappliedresearchonproblemsrelatedtothepreparation,purity,stability,andimmunogenicityofinvestigationalandlicensedvaccinesforencapsulatedbacterialpathogens.Evaluatinghost-parasiteinteractionsforpathogenesisandprotectiveimmunity.2021/7/27 星期二6Organization of the Laborator
8、y of Bacterial PolysaccharidesCarl E.Frasch,Ph.DLaboratory ChiefPathogenic NeisseriaSectionMargaret C Bash,MDMedical OfficerLipopolysaccharideSectionChao-Ming Tsai,Ph.D.BiochemistPolysaccharide and ConjugateVaccine QC Lot ReleaseChi-Jen Lee,Sc.D.BiochemistPolysaccharide ImmunitySectionCarl E.Frasch,
9、Ph.DMicrobiologistCellular ImmunologySectionMustafa Akkoyunlu,MD,Ph.D.Immunologist2021/7/27 星期二7Research Objectives:Polysaccharide Immunity SectionConductsresearchtoevaluatetheabilityofpolysaccharideandconjugatevaccinestoinduceprotectiveimmunity.Studiesdifferentconjugationchemistriestoimproveconjuga
10、teyieldsandtoimprovetheimmuneresponsetonativepolysaccharideepitopes2021/7/27 星期二8Research Objectives:Cellular Immunity SectionFocusesontheinitialphaseofpolysaccharidevaccine/encapsulatedbacteriainteractionwithhostimmunity.Seekstodefinetheinteractionofpolysaccharideswithtoll-likereceptors(TLRs)oninna
11、tecells.Thebiologicaleventsresultingfromthisinteractionmayaffectthedevelopmentofadaptiveimmuneresponsesagainstpolysaccharides.Investigatestheroleof“Aproliferation-inducingligand”(APRIL)andBLymphocyteStimulator(BLyS)ininfantandadultimmuneresponsesagainstbacterialpolysaccharides.2021/7/27 星期二9Research
12、 Objectives:Pathogenic Neisseria SectionInvestigates the Por B proteins of Neisseria gonorrhoeae and Neisseria meningitidis.StudiesthenaturalepidemiologyofPorvariationusingnovelmoleculartypingmethodsEvaluatestheeffectsofPorvariationonhost-pathogeninteractionincludingimmuneresponsestoPor,structurefun
13、ctionrestrictionsonPor,andtransmissionpatternsIdentifiesthemechanismsofPorvariationthroughinvestigationofmixedinfections,diverseandclonalpopulations.2021/7/27 星期二10Research Objectives:Lipopolysaccharide SectionConductsresearchtoevaluatechemicallyorgeneticallydetoxifiedmeningococcalLPSboundtoproteinasapotentialvaccineforgroupBmeningococcaldisease.StudiesthegeneticsofLPSbiosynthesisinpathogenicandcommensalNeisseriaspeciesandcharacterizestheirLPSimmunochemically.2021/7/27 星期二11 Thank you2021/7/27 星期二12