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Ensuring AdvEntitious AgEnt sAfEty in Biologics

creating effective strategies to mitigate risk and enable prompt remediation of viral, prion and mycoplasma contamination

two-day Conference: 18-19 october 2011 Pre-Conference focus day: 17 october 2011 nH München dornach, Munich, germany

Register & Pay by 1st Julyand save up to €450

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Interactive discussions and

networking

2 real-world contamination case

studies

HEAr froM 20 industry ExPErts inCluding:thomas r. Kreil, Ph.d.

associate Professor of virology senior director viral vaccines

& global Pathogen safety Baxter Bioscience

Jens-Peter gregersen, sme virology, virus safety,

new Projects R&d, novartis vaccines and diagnostics

Walter de Matteo, microbiological laboratory

manager, Quality control, iBsA institut Biochimique sAMarc Martin, viral safety

assessor, AfssAPsMarie Murphy,

microbiologist, Eli lillyHans nitschko, doctor of

diagnostic virology, max von Pettenkofer institute,

university of Munichtanja opriessnig,

associate Professor, department of veterinary diagnostic and Production animal medicine,

veterinary diagnostic laboratory - iowa state university

Barbara Potts, senior consultant, Potts and nelson

Consulting, llC, chair, mycoplasma task Force, PdA

fazal Khan, senior vice President of manufacturing,

MerrimackAlbrecht gröner, Head of

Pathogen safety, Csl BehringHolger Kavermann, manager Qc, roche

Emiliano toso, molecular Biology lab Head,

Merck serononathan Jones, senior

scientist, genzymesebastien Carayol,

manager of scientific Bioprocess R&d, downstream Process,

sanofi Pasteur…And MAny MorE!

Full-length mycoplasma

focus day

spotlight on prevention strategies (not just after-

the-fact containment) Contamination Conqueror!

virusure gmbH

Well selected speakers, good overview and case studies on viral safety.

sanofi-Aventis

good spread of talks-important key speakers.

don’t Miss our in-dEPtH MyCoPlAsMA foCus dAy! speakers include Roche’s Holger Kavermann and Merck Serono’s Emiliano Toso. see page 3 for details.

Contamination Conqueror!

E: [email protected] t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301

CoME AWAy WitH frEsH idEAs on: implementing the latest techniques to screen

for mycoplasma and mitigate your risk of contamination with roche Performing risk assessments to avoid tse

contamination at your facility with AfssAPs creating a contingency plan for remediation

in case of contamination at your facility with Eli lilly Best-practice approaches to dealing with actual

contaminations from genzyme and Merrimack – apply their lessons to your organisation ensuring the safety of your raw materials with

Csl Behring – get that vital first step right!

E: [email protected] t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301 2

Advisory BoArdthanks to our advisory board for lending their expert advice; their feedback and suggestions have been instrumental in helping to shape our programme!

Mark Plavsic, senior director of corporate Biosafety, genzyme

thomas r. Kreil, Ph.d., associate Professor of virology, senior director, viral vaccines & global Pathogen safety, Baxter Bioscience

James robertson, Principal scientist, virology, niBsC

dayue Chen, Research advisor, Eli lilly

Hans rogl, manager development Recovery & downstream Processing, roche diagnostics

Barbara Potts, senior consultant, Potts and nelson Consulting, llC, chair, mycoplasma task Force, PdA

Hans noordergraaf, microbiological specialist, Qc microbiology, Abbott Biologicals B.v.

Marc Martin, viral safety assessor, AfssAPs

thomas r. Kreil, Ph.d., associate Professor of virology, senior director viral vaccines & global Pathogen safety, Baxter Bioscience

Albrecht gröner, Head of Pathogen safety, Csl Behring

Marie Murphy, microbiologist, Eli lilly

santosh nanda, microbiologist/Primary Reviewer, cBeR, fdA (pending offical approval)

nathan Jones, senior scientist, genzyme

Walter de Matteo, microbiological laboratory manager, Quality control, iBsA institut Biochimique sA

rosa Anna siciliano, Proteomic and Biomolecular mass spectrometry center, institute of Food science, italian national research Council (Cnr)

tanja opriessnig, associate Professor, department of veterinary diagnostic and Production animal medicine, veterinary diagnostic laboratory - iowa state university

Jürgen A. richt, director, dHs center of excellence for emerging and Zoonotic animal diseases (ceeZad), Kansas state university

your ExPErt sPEAKEr fACulty fazal Khan, senior vice President of manufacturing, Merrimack Pharmaceuticals

Emiliano toso, molecular Biology lab Head, Merck serono

rebecca sheets, vaccine scientific and Regulatory specialist, niH/niAid (pending official approval)

Jens-Peter gregersen, sme virology, virus safety, new Projects R&d, novartis vaccines and diagnostics

Jürgen Hubert Blusch, Head cell line and adventitious agents analytics, novartis Ag

Kristin Murray, senior manager gcmc Regulatory, Pfizer

steven reich, Risk management Principal, global Quality, Pfizer

Barbara Potts, senior consultant, Potts and nelson Consulting, llc, chair, mycoplasma task Force, PdA

Holger Kavermann, manager Qc, roche

sebastien Carayol, manager of scientific Bioprocess R&d, downstream Process, sanofi Pasteur

Hans nitschko, doctor of diagnostic virology, max von Pettenkofer institute, university of Munich

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PrE-ConfErEnCE foCus dAy 17 OCTOBER 2011 MyCOplasMa MiTigaTiOn

08.30 Coffee and Registration

09.00 Chair’s Opening Remarks and Pharma IQ Welcome

09.10 Performing Risk Mitigation on Animal- and Plant-Based Raw Materials to Avoid Mycoplasma Contamination •sourcing your raw materials from a trusted supplier (and understanding what screenings your supplier uses) •Subjectingallanimal-orplant-basedrawmaterialstotestingbeforeproceedingwithproduction •Determiningthedetectionlimitsofvariousmycoplasmascreeningmethods •Evaluatingwhichdetectionmethodsaremostappropriateforwhichmaterial Hans Noordergraaf,MicrobiologicalSpecialist,QCMicrobiology,Abbott Biologicals B.v.

09.50 Networking Coffee Break

WorKsHoP A

10.20 Debunking the Myths of Mycoplasmology as Addressed in the Parenteral Drug Association’s Technical Report No. 50 attend this session to: •Reviewcommonassumptionsaboutmycoplasma–findoutwhicharetrueandwhicharefalse •AssesstheInternationalStandardforPCRtestingandmycoplasmafiltration •Evaluatenewtestingmethodsforapplicability •DiscussregulatoryexpectationsfromtheEUandUS Barbara Potts,SeniorConsultant,Potts and nelson Consulting, llC,Chair,MycoplasmaTaskForce,PdA

12.20 Networking Lunch Break

WorKsHoP B

13.30 Evaluating Alternative Mycoplasma Testing Methods attend this session to: •Examinecurrentmycoplasmatestingmethods,theirstrengthsandlimitations •Learnaboutmycoplasmacontrolandrapiddetectionusingquasireal-timesolutionsandanimal-freemediacomponents for optimal safety •Understandtheimportanceofviralinactivationcasestudiesandimplementingcomplementarytechnologiestoensureviralsafety •Explorearangeofpotentialdetectiontechnologiesandidentifytheutilityandshortcomingsofeach Emiliano Toso,MolecularBiologyLabHead,Merck serono


16.00 PCR vs. Classical Culture Testing for Mycoplasma in Pharmaceutical Production •Comparing the pros and cons of classical and pCR testing methods •ReducingtestingtimewithPCRwithoutlosingsensitivitytocontaminants •EnforcingGMPrequirementsandvalidationguidelinesforPCRtesting Holger Kavermann,ManagerQC,roche

16.40 CRISIS CLINIC: MYCOPLASMA CONTAMINATION AND MITIGATION Thisinteractivesessionwillprovideaforumtocreateastrategyformanagingahypotheticalmycoplasmacontaminationevent •Exploringtheimplicationofamycoplasmacontaminationatamanufacturingplant •Brainstormingtheimmediateconsequencesandarapidresponsetomitigatethecrisis • Implementingaplanofactiontopreventfurthercontamination •Workingaroundthepotentialaftermathandputtinginplacearoadmapfordecontaminationandrecommencementofproduction Emiliano Toso,MolecularBiologyLabHead,Merck serono

17.20 Chair’s Closing Remarks and End of Focus Day

she helped develop a key

PCr kit

His lab released the first commercial PCr kit for mycoplasma detection

w w w . a d v e n t i t i o u s a g e n t s e v e n t . c o m


dAy onE 18 OCTOBER 201108.30 Coffee and Registration

09.00 Chair’s Opening Remarks and Pharma IQ Welcome

PLANNINGANDPREVENTION

09.10 Case Study: Applying Holistic Product Protection Strategies to a Mammalian Multiproduct Facility •Creating design/segregation strategies for a new multiproductfacilitytoreduceriskofcontamination •Assessingrapidmethodsforearlycontaminationdetection •Proactivelycreatingremediationplansforcontamination Marie Murphy, Microbiologist,Eli lilly

09.50 Ensuring the Safety of Products and Biologics of Porcine Origin – A Veterinarian’s Perspective •Zoonotic,potentiallyzoonoticandmiscellaneous contaminationsinpigs:Whatshouldbetestedand surveyedfor? •“Acceptable”contaminationlevel–doesitexist? •Determiningpresenceversusviabilityorinfectivity: Whatalternativesarethere? •Removalfromtheproductversusremovalfromthepig: Whichisthebetter/safer/morecost-effectivechoice? Tanja Opriessnig,AssociateProfessor,Departmentof VeterinaryDiagnosticandProductionAnimalMedicine, VeterinaryDiagnosticLaboratory,iowa state university


11.00 Ensuring the Safety of Plasma-Derived Material •Runningriskassessmentonplasma-derivedmaterial •Controllingsourcematerialfromcollectionthrough manufacturing •Performingvirusvalidationstudiestodeterminethe efficacyofremovalmethods •Ascertainingbestmethodsforinactivatingviral contaminants Albrecht Gröner,HeadofPathogenSafety,Csl Behring

11.40 Speed Networking Like Speed Dating, But Without the Pressure to Commit You’veseeneachotheracrosstheroom…nowmeetface-to face.Bringplentyofbusinesscardstoexchangeinaseries of2-3minuteone-on-onemeetingswithyourfellow speakers,attendeesandvendors.Yourmission-learnoneof thefollowingthingsabouteachpersonyoumeet: •Whatdoyouhopetolearnfromthisconference? •Whichcompany/speakerareyoumostinterestedin hearingfrom? •Whatisyourbiggestchallengeintheadventitiousagent safetyarena?

12.10 Case Study: Learning From Genzyme’s Vesivirus Contamination and Instituting New Prevention Strategies •Helpingtounderstandtheoffendingagent:unravelingthe specificsofvesivirusbiology •Elaboratingontheadvantagesanddisadvantagesof currentinvitrovirustestingmethods •Outliningthecrucialmitigationstepsinvolvedinvirus proofing your processes •Highlightingthetypesofvirusclearancemethodsrequired toensuremaximaldefensefromcontamination Nathan Jones,SeniorScientist,genzyme

12.50 Networking Lunch Break

14.00 Mitigating the Risk of Prion Contamination •UnderstandingthecausesofBSE •Creatingprion-free“knockoutcattle”andevaluating their uses •Ensuringthepurityofyoursourcematerials •Proactivelycreatingremediationplansintheeventof contamination Jürgen A. Richt,Director,DHSCenterofExcellencefor EmergingandZoonoticAnimalDiseases(CEEZAD), Kansas state university

14.40 Investigating Best Methods for Ensuring TSE Safety •PerformingriskassessmentforTSE •Understandingguidelinesandensuringregulatory compliance •PerformingvalidationtoremoveTSE Marc Martin,ViralSafetyAssessor,AfssAPs


DETECTIONANDVALIDATION

15.50 Break-Out Roundtable Discussions Participantswillbeabletochooseoneoftworoundtables anddiscussthepointsoutlinedbelow

Roundtable A: Assessing Novel Analytical Techniques Thisdiscussionwillsurveynewanalyticalmethodologies suchasmathematicallyparallel/next-generation sequencing;howdoyoudeterminewhentheseintensive, expensivetechnologiesarenecessaryversuswhenthey’re excessive(andwilltheybecomeroutine)? Moderator: Jürgen Hubert Blusch, HeadCellLineand AdventitiousAgentsAnalytics,novartis Ag

Roundtable B: Emerging Detection Technologies and Their Applications Thisdiscussionwillfocusonavailabletoolsasappliedinthe biotechindustriesfortheaccuratesensingofviral contaminants,andhowtheycanbeappliedtoultimately virus-proofyourbioprocesses Moderator: Thomas R. Kreil, Ph.D.,AssociateProfessor ofVirology,SeniorDirectorViralVaccines&GlobalPathogen Safety,Baxter Bioscience

16.30 How to Maximise the Potential and Avoid the Deficiencies of Nucleic Acid Testing (NAT) •identifying when to use naT as opposed to direct microbiologicalculturetesting •ComparingdirectNATandNATcombinedwithan enrichment step •AnalysingthedeficienciesofNATversusitsbenefits •Takingacloserlookatsensitivity,specificityand reproducibilityofNAT/PCRtestingforoptimalvirus safety screening Hans Nitschko,DoctorofDiagnosticVirology,Maxvon PettenkoferInstitute,university of Munich

17.10 Validation of Viral Testing Method for Human-Derived Raw Materials •Performingviralanalysisonrawmaterialsderivedfrom human urine •Understandingtheneedforvalidation •TestingrawmaterialsforHIV,HCV,andHBV •Selectingavalidationmethodandvalidatinginaccordance withICHguidelines Walter De Matteo,MicrobiologicalLaboratoryManager, QualityControl,iBsA institut Biochimique sA

17.50 Chair’s Closing Remarks and End of Day One

CASESTU

DY

ROUNDTABLE

CASESTU

DY

www.adventitiousagentsevent.com

He helped genzyme

recover from contamination

He created prion-free ‘knockout

cattle’


08.30 Coffee and Registration 09.00 Chair’s Opening Remarks and Pharma IQ Welcome CONTAINMENTANDREMEDIATION9.10 Case Study: How Merrimack Suffered - and Recovered From - an MVM Contamination •DetectingtherootcauseoftheMVM(MinuteVirusof Mice) contamination •Effectivelycontainingthecontaminationtoavoidspread throughout the facility and into product •Utilisingappropriateremediationtechnologies •Formulatingpreventionstrategiestocircumvent future contaminations Fazal Khan,SeniorVicePresidentofManufacturing, Merrimack Pharmaceuticals09.50 Evaluating the Efficacy and Applicability of Cleanup Methods •Surveyingavailablemethodsforpost-contaminationcleanup •Determiningwhichtechnologiesaremosteffectiveat remediatingvaryingtypesofcontamination(e.g.,viral, mycoplasma,bacterial) •Optimisingfacilityandprocessdecontaminationusing cleaningagentswithknownvirucidalefficacy Jens-Peter Gregersen,SMEVirology,VirusSafety,New ProjectsR&D,novartis vaccines and diagnostics10.30 Networking Coffee Break 11.00 Developing an Effective Viral Clearance Strategy for Vaccines •Determininganeffectivepurificationprocessfor virusremoval •Creatingaviralclearancestrategyandvalidation methodology •Achievingviralvaccineinactivationthroughstandard inactivationmethods •Utilisingrecombinantproteinsinviralinactivation Sebastien Carayol,ManagerofScientificBioprocessR&D, DownstreamProcess,sanofi Pasteur11.40 Speed Networking Like Speed Dating, But Without the Pressure to Commit You’veseeneachotheracrosstheroom…nowmeetface-to face.Bringplentyofbusinesscardstoexchangeinaseries of2-3minuteone-on-onemeetingswithyourfellow speakers,attendeesandvendors.Yourmission-learnoneof thefollowingthingsabouteachpersonyoumeet: •Whichcontaminantisyourgreatestbugbear?Prions, mycoplasma,bacteria–pickyourpoison! •Whichareyourpreferredtestingmethods? •Arethereanydevelopmentsintesting/purification techniquesthatyouthinkholdparticularpromise? UNDERSTANDINGREGULATIONSAND ACHIEVINGCOMPLIANCE12.10 Systematically Characterising Adventitious Agent Tests for Biologics •Assessingthebreadthandsensitivityofroutine adventitiousagenttests •Harmonisingtestmethods(bothexistingandemerging) •Discussingthepolicyperspectiveonadaptingnew testing methodologies Rebecca Sheets,VaccineScientificandRegulatory Specialist,niH/niAid(pendingofficialapproval)12.50 Networking Lunch Break 14.00 Evaluating the Safety of New Flu Vaccine Development Methods—A Regulatory Perspective •Movingawayfromegg-basedfluvaccineproductionand towardfaster,cell-basedvaccineproduction

•Assessingtherisksofthecell-baseddevelopmentprocess (forexample,whichplantviruscanbetransmittedtohumans) •Creatingsafetyprotocolsforthisnewproductionmethod •Investigatingthechallengesandbenefitsofutilisingcell basedvaccinedevelopmentanddevelopingregulatory guidancetogoverntheprocess Santosh Nanda,Microbiologist/PrimaryReviewer,CBER, official(pendingFDAapproval) HIGHLIGHTINGNEWTECHNOLOGIES14.40 A Risk Assessment Model to Predict the Likelihood of Influenza Vaccine Contamination •Creatinganeffectivemodeltoassesstheriskofviral contaminationoftheinfluenzavaccine •Comparingthelikelihoodofcontaminationofegg-based fluvaccineproductionwiththatofcell-based vaccineproduction •Gaugingthebasicgrowthcharacteristicsofeachvirus, itsabilitytogrowindifferentcellsubstratesandresistance toprocessingstepsduringvaccinemanufacture Jens-Peter Gregersen,SMEVirology,VirusSafety,New ProjectsR&D,novartis vaccines and diagnostics15.20 Networking Coffee Break15.50 Implementing Nanofiltration for Pathogen Reduction •Analysingcurrentnanofiltersandassessingtheirpotential toremoveviralcontaminants •Findingtherightfiltrationsystemforyourneeds: nanofiltrationversustraditionalfiltrationsteps •Ensuringregulatorycomplianceinthevalidationofvirus filters and filtration •Hypothesisingfuturedevelopmentsinnanofiltration Thomas R. Kreil, Ph.D., AssociateProfessorofVirology SeniorDirectorViralVaccines&GlobalPathogenSafety, Baxter Bioscience16.30 Utilising MALDI-TOF Mass Spectrometry for Rapid Bacterial Identification •UnderstandingthebasicprinciplesofMALDI-TOF mass spectrometry •CreatingananalyticalstrategybasedonMALDI-TOF-MS forrapidbacterialidentification:recentdevelopmentsin protocols,instrumentationandbioinformatictools. •UsingMALDI-TOF-MSinroutinemicrobiologicallaboratories: anoverviewofrecentpublicationsonthetopic •Evaluationofstrengthsandweaknessofthemethodology Rosa Anna Siciliano, proteomic and Biomolecular Mass SpectrometryCenter,InstituteofFoodScience,italian national research Council (Cnr)17.10 Utilising Quality Risk Management (QRM) to Ensure Pathogen Safety in Biopharma Manufacturing •Optimisingviralcross-contaminationriskmanagement incontemporarymulti-productandmulti-host manufacturing facilities •UsingQRMtoevaluateandmitigatepotentialviral carryoverinequipmentsharedbetweendifferenthost cell processes •UseofexploratoryriskassessmenttoolssuchasFaultTree Analysistocomprehensivelyidentifyandscopeviral contaminationrisks •Demonstratingviralinactivationcapabilitiesofequipment andfacilitycleaningproceduresviaHazardsAnalysisand CriticalControlPoints(HACCP) Steven Reich,RiskManagementPrincipal,GlobalQuality, Pfizer Kristin Murray,SeniorManagerGCMCRegulatory,Pfizer18.00 Close of conference and Chair’s closing remarks

dAy tWo 19 OCTOBER 2011CA

SESTU

DY


His studies can help you clean up your contamination

He’s exploring the potential of nanofiltration


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Frombiotech,pharmaceutical,biopharma and regulatory organisations

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Ensuring AdvEntitious AgEnt sAfEty in Biologics

two-day Conference: 18-19 october 2011 Pre-Conference focus day: 17 october 2011 nH München dornach, Munich, germany

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* Pleasenotepharmaandbiotechpricingdoesnotapplytoserviceproviders,includingCMOs,CTOs,etc.** Toqualifyfordiscounts,paymentmustbereceivedwithbookingbythediscountdeadline. Earlybookingdiscountsarenotvalidinconjunctionwithanyotheroffer.*** Tickthisboxifyouwishtooptoutoffullconferencerecordings(reducingthepriceby€550)GermanVATischargedat19%.VATRegistration#:DE261101914Academic Rate/Small Biotech: Ifyouareanacademicorworkforasmallbiotechwithbetween2and100people,youqualifyfor a50%discount.Pleasenotepharmaandbiotechpricingdoesnotapplytoserviceproviders,includingCMOs,CTOs,etc.

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