extractactables and leachables summit 2020 · 2020-03-09 · register now to guarantee your space!...

PharmaEd Resources, Inc. • 2810 Robeson Park Drive • Champaign, IL 61822tel. 217.721.5774 • web. www.pharmaedresources.com

Extractables & Leachables Summit 2020Ensuring Quality, Safety, Suitability and Regulatory Compliance

for Drugs, Biologics and Medical DevicesJuly 30–31, 2020, Wyndham Philadelphia Historic District

Featuring Lessons Learned and Case Studies from Industry Experts:

With Representation From:

• CDRHScientificPerspectiveonChemicalAnalysisforMedicalDevices

• ISO10993-18:KeyConceptsandPracticesforEffectiveandCompliantChemicalCharacterizationSupportingtheBiologicalEvaluationofMedicalDevices

• UnderstandingtheMajorRevisionstoISO10993andtheNewEuropeanMedicalDeviceRegulations

• CaseStudy:MedicalDeviceToxicologicalRiskAssessmentFollowingNewPrinciplesofISO10993-17

• IdentificationandEvaluationofMaterialQualityAttributes(MQA)ofPolymerics

UsedinCellTherapyProductsManufacturing

• ChemicalInteractionsbetweenLeachablesandBiopharmaceuticals

• TheNeedtoIdentifyUnknownsfromaToxicologicalPerspective

• BPOGE&LforSingle-UseSystems– TheFinalChapter

• UtilizingBPOGdataforselectionandqualificationofSingleUseSystems

• Extractables/LeachablesStudies:AreYouCertainAboutthatUncertainty?

• ReducingResponseFactor(RF)VariationandtheneedforUncertainty

Factors(UFs)inExtractablesandLeachables Analysis

• ComparisonoftheSolubilizationPropertiesofPolysorbate80andIsopropanol/WaterSolventSystemsforOrganicCompoundsExtractedfromThreePharmaceuticalPackagingConfigurations

• ComprehensiveExtractablesStudyofAutoclavablePolyethersulfoneFilterCartridges

• Physics-basedModeltoPredictPatientExposuretoPolymerAdditivesinMedicalDeviceMaterials

• AndMuchMore!

MikeRubertoMaterial Needs

James HathcockPall Biotech

Cherry ShihPall Life Sciences

SteveZdravkovic

PPD

RobertoMenzel

Sartorius Stedim

Eric HillBoston

Analytical

StephenDohertyToxikon

Daniel Norwood

Feinberg Norwood & Assoc.

MarkJordiJordi Labs

PietChristiaensNelson Labs

With Comprehensive Coverage On:

MikeEakinsEakins & Assoc.

DavidSaylorFDA

DennisJenkeTriad Scientific

SherryParkerWuXi AppTec

LisaOlsonNAMSA

Carsten Worsøe

Novo Nordisk

PingWangJohnson &

Johnson

TedHeiseMED Institute

BerkOktemFDA

RonBrownFDA (retired)

CharlesFeliceJanssen R&D

Register Now to Guarantee Your Space! Online: www.pharmaedresources.com • Phone: 217.721.5774

PharmaEd’sExtractables&LeachablesSummit2020isSponsoredby:

Extractables & Leachables Summit 2020

INNOVATE WITH CONFIDENCE

Register Now to Guarantee Your Space! Online: www.pharmaedresources.com •Phone: 217.721.5774


Recent, largely anecdotal, evidence suggests that thisexpectationofreproducibilitycouldbemoreawishthanarealityandthatextractablesprofilescanvary,insomecasesquitesubstantially,fromlabtolabandpossibilityevenwithinalab.Ifthislackofconsistencyistrueandreal,itcouldhaveasignificantbearingon,forexample,theuseofchemicalcharacterizationinthebiocompati-bilityassessmentofmedicaldevices.

In this presentation we will examine the published andavailableliteratureanddatathatisrelevanttothistopictoestablishwhethertheperceptionisrealityand,ifso,tocon-sideractionsthateitheramplifyorreduce/controlvariation.Furthermore,theavailableliteratureanddatawillbeusedtoquantifyreasonableexpectationsforreproducibility.

10:40 ICHE&LGuidelinesUpdateCarsten Worsøe, Principal Scientist, Novo Nordisk

The InternationalCommittee forHarmonisation (ICH)har approved the procurement of an ICH E&L guide-line.Althoughit isveryearly in the ICHprocessthis

shortpresentationwillgivebackgroundandhistory forthetopicapprovalinICHaswellasthecurrentlyknownprocessfortheICHguideline.

Q&A: Ask the Experts

10:50 E&LRegulatoryPanelDiscussionModerator: Michael Eakins, Owner, Eakins & AssociatesPanel:

• DennisJenke,TriadScientificSolutions • RonaldBrown,Toxicologist,FDA(retired) • BerkOktem,Chemist,FDA

Discussants:TheAudience

11:20 ReducingResponseFactor(RF)Variation andtheneedforUncertaintyFactors(UFs) inExtractablesandLeachablesAnalysis

Dr. Mark Jordi, President, Jordi Labs

Chemical characterization per ISO 10993 has becomean importantcomponentofbiocompatibility testingofmedical devices. Similarly, pharmaceutical packag-ing is characterized for extractables and leachables

toverify thesafetyofdrugproductsperUSP<1663>and<1664>. A major concern regarding the accuracy of ex-tractables and leachables studies is quantitative errordue to response factor (RF) variation. This error occursbecause many extractables do not have commerciallyavailable standards and equal concentrations of differ-ent extractables give different signal responses usingmass spectrometry detectors. Recent publications havehighlightedtherisksposedbyRFvariationforbothLCMSandGCM. The importance of this issue has been recog-nizedbytheFDAresultingintheadditionofanuncertaintyfactor(UF)inthecalculationoftheanalyticalevaluation

Thursday,July30

7:30 Registration & Complimentary Breakfast & Chairperson Mike Eakins’ Welcome

Regulatory Spotlight – Chemical Analysis for Medical Devices

8:10 CDRHScientificPerspectiveonChemicalAnalysisforMedicalDevices

Berk Oktem, Chemist, FDA

AbstractComingSoon

Critical Issues – Identifying Unknowns in E/L Studies

8:55 TheNeedtoIdentifyUnknownsfromaToxicologicalPerspective

Ron Brown, Toxicologist FDA (retired)

When conducting a toxicological risk assessment ofextractableand leachable (E&L) compounds, it is typ-ically assumed by the toxicologist that the extractedcompoundshavebeenidentifiedwithahighdegreeof

certainty.However,becauseofanalyticalchemistrychal-lenges,identificationofthecompoundstothislevelofcer-tainty isnotalwayspossible,especially fornon-targetedextractables. This talk with explore the implications ofconductingatoxicologicalriskassessmentofcompoundsthathavebeenonlytentativelyidentifiedandwillevaluaterecentproposalstoevaluatethesafetyofunidentifiedandpartially identifiedE&Lcompounds.Amongthestrategiesto be addressed in this presentation are the appropriateuseofThresholdofToxicologicalConcern(TTC)valuestoserveasdefaultTIorPDEvaluesforcompoundsthathavenotbeenconfidentlyidentifiedandneedtoidentifywhenacompoundisexpectedtobefoundinanextractbasedonknowledgeof thecompositionof thepolymericmaterialsofconstructionofthedeviceorpharmaceuticalpackaging.

9:35 Coffee & Networking Break

10:00 Extractables/LeachablesStudies:AreYouCertainAboutthatUncertainty?

Dennis Jenke, President, Triad Scientific Solutions

Therearemanywell-establishedandwell-articulat-ed expectations for extractables profiles includingthat all extractables above the AET be discovered,

correctly identifiedandaccurately quantified.A funda-mentalexpectationthathasrarelybeenarticulateduntilrecentlyisthattheextractablesprofilebereproducible.Thatistosaythatifatestarticlewereprovidedtosev-eral expert testing laboratories, the extractables pro-files reportedby those laboratorieswouldbesimilar, ifnot equivalent, in their important details, including thenumber of extractables reported and the identities andconcentrationsofthereportedextractables.



Case Studies – Utilizing BPOG data for selection and qualification of Single Use Systems

2:20 UtilizingBPOGDataforSelectionandQualificationofSingleUseSystems

Cherry Shih, Senior Scientist, Pall Life Sciences

The increasing availability of extractable datasetsaligned to standardized protocols (BPOG and USP<665>/<1665>) has led to a deeper understanding of

extractableprofilesindifferentsolvents.WewillsharecaseswherespecificsolventprofilesfromBPOGorUSP<665>canbeleveragedtobestsupportandsimplifytheriskassessmentprocess,forboth,thepurposeofinitialmaterials selection aswell as qualification of amulti-component single use system in a definedmanufactur-ingprocess.Inapplyingstandardizeddatasets,weshareexamplesofhowextractablesprofilesperformedatdif-ferentsurfaceareatovolumeratios(0.4to18sq.cm./mL)comparetotheoreticallyscaledvaluesbasedonsurfaceareaandvolumealone.Thegoalofthesecasestudiesistosimplifyandstrengthenapproachestoqualificationofsingleusematerials.


3:25 ComprehensiveExtractablesStudyofAutoclavablePolyethersulfoneFilterCartridges

Roberto Menzel, Laboratory Supervisor, Extractables & Leachables, Sartorius Stedim

Sterile filters are ubiquitous in biopharmaceuticalmanufacturingprocesses. Theyare in direct contactwiththeprocessfluid,andtheprofilingoftheextract-

ablesisofhighimportance,especiallyinprocesssteps“close topatient”suchassingle-use final fill.The talkwill compare and discuss the extractables profiles ofsterilizing-grade0.2µmpolyethersulfonemembrane fil-ter cartridges from different vendors. Pure ethanol andpurifiedwaterwere used as extractionmedia. SeveralorthogonalanalyticaltechniquessuchasHSGC-MSandGC-MS and LC-HRMS in combination with ICP-MS forsingleanalytedetectionandthesumparameterstotalor-ganiccarbon,non-volatileresidue,conductivity,andpHwereusedtoobtainamostcomprehensiveextractablesprofile.Variousextractableswerefoundsuchasantiox-idantsanddegradationproducts thereof, hydrocarbons,and processing aids. The identified compounds can allassignedtothematerialsofconstruction,suchasplasticpartsormembranes.Focusisgivenalsoonthechalleng-esoneencountersinExtractablesscreeningstudiesforexampleintheanalysisofhydrophilizingagents.Abasictoxicologicalevaluation formaterialsafetyassessmentwillbepresentedshowingtheoveralllowriskoftheex-tractablestowardpatientsafety.

threshold(AET).Whilethisaidsinmitigatingtherisksofunderreportingofextractables,theresultingrevisedAETcreatessignificantanalyticalchallengesoftenexceedingthelimitofdetection(LOD)ofcurrentmassspectrometryinstrumentation and requiring sample concentration. Italso creates questions as to the validity of risk assess-mentsbasedonrelativequantitationvaluesandisoneofthekeyissuesattherootofpoorreproducibilityinrecenthighprofileinterlaboratorystudies.Itisthereforestrong-ly desirable to define improvedmethods for quantitationwithmoreuniversalRFswhichmitigatetheneedforUFs.Inthispresentation,alternativestrategiesforquantitationusing tripledetection liquidchromatographymassspec-troscopy (LCMS)withultraviolet (UV)andchargedaero-soldetection(CAD)aswellasGasChromatographyMassSpectroscopy(GCMS)withsimultaneousFlameIonizationDetection(FID)willbepresented.Datacomparingthere-sponsefactorsavarietyofextractablesbyUV,MS,FIDandCADwillbepresenteddemonstratinganapproachtore-duceoverallRFvariation,theassociatedneedforUFsandincreasingconfidenceintheresultingriskassessments.

12:00 Complimentary Networking Lunch

1:00 IdentificationandEvaluationofMaterialQualityAttributes(MQA)ofPolymericsUsedinCellTherapyProductsManufacturing

Ping Wang, Director, Johnson & Johnson, and Charles Felice, Principal Scientist, Janssen R&D

Cell therapy drug products such as CAR-T presentuniquechallengeswithrespect topolymericmaterialriskscomparedwithmorecommonbiologicprocesses.Themanufacturingprocessofcellproductshasfewerpurification steps, resulting in fewer opportunities toremovepolymeric-relatedimpuritiessuchasparticles,endotoxins,bioburden,andleachables&extractables.

These attributes are material quality attributes (MQAs)thatmustbeassessedand, if the risk ishigh,mitigated.Thispresentationwilldiscussthecorrelationofmanufac-turingprocessesandMQAs,andhowtheseprocesseswillimpacttherisklevelsoftheMQAstothefinaldrugproductqualityandpatientsafety.TheMQArisklevelsofthepoly-mericsateachstepwillbediscussed.

Research Spotlight – Single Use Systems & BPOG

1:40 BPOGE/LforSingleUseSystems–TheFinalChapterCarsten Worsøe, Principal Scientist E&L, Novo Nordisk, and James Hathcock, Senior Director, Regulatory and Validation Consulting, Pall Biotech

Inthispresentation,wewillcoverthefollowingtopics:

• Supplierandend-usercollaboration• Extractablesecosystem• Datareviewprocess• Extractablesprotocolupdate• Communityofpractice



MSforvolatileanalytes,Directinjection(DI)GC/MSforsemi-volatileanalytescontainedinsolventextracts,Di-rectinjectionLC/MSfornon-volatileanalytescontainedin solvent extracts, and ICP/MS for elemental analytes.Theconsensusdoesnotincludeallofthedetailsoftheanalyticalmethods since the organizations that agreedon best practices did notwant to be proscriptive. Thispresentation will attempt to discuss the possibility ofestablishing standard methods for extractables/leach-ables. It will describe the requirements for standardmethodsalongwiththeimplicationsforthepharmaceu-ticalindustryoftheimplementationofstandardmethods.Theexperienceoftheenvironmentalindustrywithstan-dardmethodsinthe1970sand1980swillbeconsidered.

5:20 End of Day One

Friday,July31

8:00 Complimentary Breakfast

Critical Issues—Exploring the Major Revisions to ISO 10993-1, -17, & -18: Methodological & Toxicological Considerations

8:30 ToxikonPresentationStephen Doherty, Associate Director, Analytical Chemistry, Toxikon

Abstractcomingsoon

9:00 ISO10993-18:KeyConceptsandPracticesforEffectiveandCompliantChemicalCharacterizationSupportingtheBiologicalEvaluationofMedicalDevices

Ted Heise, Vice President, Regulatory & Clinical Services, MED Institute

TheISO10993seriesofstandardsonbiologicaleval-uationofmedicaldeviceshasbeenevolvingovertheyears,workingtokeepupwithprogressinknowledge

of the subjectmatter. In keepingwith this progress, anupdateofISO10993-1(thetop-levelstandard)publishedin2018.Akeychangeinthisreviseddocumentwastheaddition of a more explicit requirement for chemicalcharacterization of all device types—regardless of thenatureanddurationofpatientcontact.

To meet the heightened focus on chemical characteri-zation—and to update the existing standard—a majorrevision of ISO 10993-18 “Chemical characterizationof medical devicematerialswithin a riskmanagementprocess”wasundertaken.Thereviseddocumentshouldpublishinearly2020.Thisconferencesessionwillfocusonkeypartsofthenewdocument,bringinginexperienceandlessonslearnedfrommulti-stakeholderdevelopmentofthefinalstandard.

4:05 AssessingtheReactivityofLeachableswithBiopharmaceuticals,UsingINSULINasaMarkerCompoundCombinedIn-SilicoModelwithExperimental(Analytical)VerificationofProofofConcept,usingINSULINasaMarkerCompound

Piet Christiaens, Scientific Director, Nelson Labs Europe

In the EPREX case, leachable induced immuno-re-sponsescausedsevereadversereactionstoCKDpa-tients. Although the EPREX case is often referred to

by theE/Lcommunity tostress the importanceofan in-depth E/L evaluation of the C/C-system, it also showedthat the traditional E/L approach for container/closuresystems may not always be adequate in predictingleachables could chemically modify proteins, poten-tially causing immunogenicity through the formation of“anti-drug-antibodies.”

TheFDAGuidanceforIndustry:“ImmunogenicityAssess-mentforTherapeuticProteins”(2014)describesanaphy-laxis, cytokine release syndrome, infusion reactions,non-acutereactionsandcross-reactivitytoendogenousproteinsastheassociatedsafetyconcernswhenconsid-eringimmunogenicityasaresultofchemicalinteractionbetweenleachablesandproteins.

Thepresentationwilladdresstwowaysofpredictingifanyofthechemicalcompounds,foundintheextractionprofileofcontainer/closurecomponent,could lead toachemical interactionifanyof thoseextractableswouldbecomea leachable: (1)howtoperformanin-silicore-activityapproachofaverybroadsetofcommonlyknownextractablecompoundsand(2)achemicalreactivitytesttoactuallyscreenforresidualchemicalreactivity.

Inaddition,achemicalreactionmodel,basedonInsulinasamarkercompoundwasdevelopedtoactuallyverifythein-silicopredictedchemicalreactivityandcomparetheoutcomeof thein-silicoexercisewiththeobservedreactivitybetweenapredefinedsetofextractablesandinsulin.

4:45 StandardMethodsforExtractables/LeachablesProfiling:WhataretheImplications?

Daniel Norwood, Principal Consultant, Feinberg Norwood & Associates

Modern analytical chemistry, in the form of GC/MSand LC/MS,hasbeenat center stage inextractable/leachable assessment since the late 1980s. Various

organizations (PQRI, USP, etc.) have attempted to es-tablish the basic scientific principles for accomplish-ing extractables/leachables assessments along withthe use of these highly sensitive and selective analyti-cal techniques.Overthepast tenyearsorso,ageneralconsensus has been established regarding the suite ofanalytical techniquesapplied toanyassessmentbasedon thevolatilityandchemicalnatureof theanticipatedanalytes.Thisconsensusincludes:Head-space(HS)GC/



Q&A: Ask the Experts

10:35 ISO10993PanelDiscussionModerator: Michael Eakins, Eakins & Associates

Panel:

• StephenDoherty,Toxikon• TedHeise,MEDInstitute• SherryParker,WuXiAppTec

Discussants:TheAudience

11:15 CommercialImplicationsofaProperlyPlannedBiologicalEvaluationStrategy,Including theUseofChemicalCharacterization

Lisa Olson, Vice President — North American Laboratory and Global Analytical Services, NAMSA

Since2009, theemphasisonariskmanagementpro-cess and characterization of materials continues to

shiftthebiologicalsafetyparadigm.Putsimply,thedaysof medical product manufacturers simply contractingwithatestinglaboratorytoperformahandfulofbiologi-calsafetytestsisnolongeranacceptedpracticebyanyglobal regulatory body. Medical device regulators arerequiringcarefullyplannedevaluationstrategiesbasedonriskandempiricaldata.

Join this session to learn howawell-planned strategyutilizing chemical characterization can have favorableandevencostsavingimplicationsforthecommercializa-tionofyourproduct.Thissessionwillbeastarttofinish,stepbystep instructiononwhentostartyourplanning,whatstepsto followtoexecutechemicalcharacteriza-tion testing and/or biological testing, and how to keepyourtimelinesasshortorshorterthanwhenperformingconventionalbiologicaltesting.

12:00 Complimentary Networking Lunch

1:00 Physics-basedModelstoPredictPatientExposuretoMedicalDeviceLeachables

David Saylor, Materials Scientist, FDA

Thematerialsthatcomprisemedicaldevicescontainsubstancesthatcanbetransferredtopatients.Patientexposure to thesesubstancesmaybedesirable,e.g.drug delivery, but more generally, there is concern

foradverseeffectsifachemicalisreleasedinsufficientquantities.Historically,thelikelihoodforadverseeffectshasbeenevaluatedusinganimal testing. Toxicologicalriskassessment(TRA)isanalternativeapproachthatcanobviatetheneedforextensiveanimaltesting.TRArelies

Topicstobecoveredwillinclude:

• Navigatingtheflowchart,includingfactorsthatcanhelpdeterminewhethercompositionalinformationmaybeadequateforchemicalcharacterization,oranalyticaltestingofextractsislikelytobenecessary;

• Considerationsfordeterminingextractionconditions;namely,solventselection,temperature,duration,andnatureofextraction(e.g.,simulateduse,exaggerated,orexhaustive);

• DistinctionsbetweenextractablesandleachablesintheapplicationofestablishedE&Lprinciplestomedicaldevices;

• Approachestoperforminganexhaustiveextraction,aswellasdiscussionofhowmultiplestepscanfacilitateuseofpracticalsafetythresholds;

• Qualificationofanalyticalmethods,includingdiscussionofparametersthatmaybecandidatesforuse;and,

• Additionalinsightsdrawnfromregulatorinputduringnumerousdiscussionsofvariouselementsofthestandard.

9:35 CaseStudy:MedicalDeviceToxicologicalRiskAssessmentFollowingNewPrinciplesofISO10993-17

Sherry Parker, Senior Director of Regulatory Toxicology, WuXi AppTec

ISO10993-17,whichwaslastrevisedis2002,hasun-dergoneasignificant revisionand theproposed titleis“ToxicologicalRiskAssessmentofMedicalDevice

Constituents”. The revised standard will expand fromcurrent guidance on establishing allowable limits ofleachablesubstances,toconductingatoxicologicalriskassessment of medical device constituents. Proposedupdates to the standard and its current status will bepresented.Topicswillincludehazardidentification,ex-posureassessment,dose-responseassessment,andriskcharacterization. Therewill be emphasis on the use ofexpertjudgementtodeterminewhetherthetoxicologicalrisksofexposuretoextractableorleachablechemicalsinmedicaldevicesareacceptable,whatadditionalstepsmaybe taken tomitigate risk, includingwhetherexpo-sureestimatescouldbefurtherrefinedthroughaddition-al chemical characterization and when to recommendriskcontrol.Inaddition,thetechnicalspecificationISO/TS 21726:2019, Application of the Threshold of Toxico-logicalConcern (TTC) forAssessingBiocompatibilityofMedicalDeviceConstituents,willbediscussed.Acasestudywillbepresented toprovideexamples todemon-stratetheapplicationofthenewprinciplesproposedinISO10993-17and ISO/TS21726 to the toxicological riskassessmentofmedicaldevices.

10:10 Coffee and Networking Break



compatibilityusingthemanufacturingconditionsofuse,including timeand temperature. This extractables test-ingalsoshouldbeperformedusingtheactualsolutionscontacting each SUSmaterial. Case study examples ofextractablestestingformaterialcompatibilityandquali-ficationwillbepresented.

3:30 ComparisonoftheSolubilizationPropertiesofPolysorbate80andIsopropanol/WaterSolventSystemsforOrganicCompoundsExtractedfromThreePharmaceuticalPackagingConfigurations

Steve Zdravkovic, Senior Research Scientist, PPD

It has been reported that the presence of polysor-bate 80 in a pharmaceutical product’s formulationmay increase the number and/or amount of impuri-

tiesleachedfrommaterialsusedduringitsmanufacture,storage,and/oradministration.However, it isuncertainif/how the solubilization properties of this surfactantcompare to non-surfactant solvent systems. The goalof this study is to provide insight into this area of un-certainty by comparing the solubilization properties ofpolysorbate 80 to those of isopropanol/water solutionswhile in contact with a plasticized polyvinylchlorideparenteraldeliverybag,asingle-usetypemanufacturingbag,andapolypropylenebottle.Thesepropertiesweredeterminedviaabindingexperiment, inwhicha setofmodelcompoundswasintroducedintothesolutions,andviaanextractionexperiment,inwhichcompoundswereextracted fromthepackagingmaterialby thesolutions.Inbothexperiments,theamountofeachcompoundpres-entatequilibriumwasassayed todetermine theextenttheywere solubilized by the solution from the packag-ing material. Results from these experiments illustratedifferences in themagnitude of solubilization obtainedfromsolutionscontainingpolysorbate80ascomparedtothose composed of isopropanol/water. However, itwasalso demonstrated that their solubilization propertiescanbelinkedviaamathematicalmodel.

4:10 Close of Program

onexposureestimation,yetexposuredataarechalleng-ingtoobtainandinterpret.Physicsbasedmasstransportmodelsprovideapromisingalternativetoestablishclini-callyrelevantexposureestimates.Thispresentationwillprovideanoverviewofexposuremodelsandtheiruseinbiologicalriskevaluationofmedicaldevices,including:potentialbenefitsandcurrentuseinregulatoryapplica-tions, typesofmodelsthatcaninformTRAs,challengeswithuseinregulatorydecisionmaking,andstrategiestoovercomethesechallenges.

1:55 ManagingtheRiskofLeachablesthroughProactiveMaterialSelectionand

Michael Ruberto, President, Material Needs Consulting

Abstractcomingsoon


2:50 ExtractablesScreeningofSingleUseComponentsforQualification

Eric J. Hill, Director, Boston Analytical

SingleUseSystems(SUS)presentchallengeswithre-gards toextractablesand leachables, however theirease of use, quick change out capability, cost, andconfigurational flexibility provide significant advan-

tagesovertraditionalmanufacturingset-ups.WiththesechallengesregardingE&L,muchattentionhasbeenpaidto extractables data generation for use in vendor andmaterial selection.Ongoing discussions in the industryrevolvearoundtheBioPhorumOperationsGroup(BPOG)Standardized Extractables Testing Protocol for Sin-gle-UseSystems inBiomanufacturingand theproposedUSP<665>monographforsingleusesystems.Regardlessofhow thesediscussions resolveamongst the industry,after an SUS is selected there is still testing thatmustbeperformed.Thedatageneratedduringselectionisof-tennotrobustenoughforqualificationoftheSUSmate-rials for use in the manufacturing setting. It is criticalto perform extractables testing of the SUS formaterial

PharmaEd Resources, Inc. • 2810 Robeson Park Drive • Champaign, IL 61822

CHECKREGISTRATION:Topaybycheck,pleaseprovideapurchaseorderbelow.Pleasenotethatallpaymentsmustbereceivedfive(5)dayspriortotheconferencetoensurespace.Attendeeswillnotbeadmittedtotheconferencewithoutfullpayment.PURCHASEORDER#:

PLEASENOTE:PharmaEdResourcesdoesnotofferrefunds.However,ifyoucannotattendafterregistering,wearehappytoapplyyourregistrationfeetoanother PharmaEdResourcesevent,ortransferyourregistrationtoacolleague. Noticeofcancellationmustbereceivedatleast5dayspriortotheevent.

Pleaseregistermefor:Extractables & Leachables Summit 2020StandardRegistration: $1,595EarlyBirdRegistration(byJanuary21st): $1,395Callforgovernment,academic,ornon-profitrate

PAYMENTMETHODCREDITCARDREGISTRATION:c CREDIT CARD c VISA c MASTERCARD c AMEXNAME:CARD#:EXPIRATION: /SIGNATURE:BILLINGADDRESS:

Registration Information

VENUE INFORMATION:

Event Dates: July 30–31, 2020Venue/Hotel: Wyndham Philadelphia

Historical DistrictAddress: 400 Arch St Philadelphia, PA. 19106HotelPhone: (866) 266-3306

Register for the conference using one of three options:Online: www.pharmaedresources.com Phone: (217) 721-5774Mail: 2810 Robeson Park Drive, Champaign, IL 61822

About Your Conference DestinationThe Wyndham Philadelphia Historic District is simply the best of both worlds. Just one block off Market Street and within walking distance of popular landmarks, including Independence National Park, Liberty Bell Center, Independence Hall, and Betsy Ross House. We’re also minutes away from the Philadelphia Convention Center, Art Museum, the Barnes Foundation, Franklin Institute, Rittenhouse Square, Penn’s Landing, and the Central Business District. Whether you’re staying for work or play, you’ll find well-designed spaces and thoughtful conveniences to help you make the most of your stay, like free WiFi, a seasonal rooftop pool, a fitness center, and Coin’s Restaurant & Pub, our onsite eatery.

Please Complete the FollowingFIRST NAME:

LAST NAME:

TITLE:

COMPANY:

ADDRESS:

ADDRESS:

CITY: STATE:

ZIP: COUNTRY CODE:

OFFICE PHONE:

MOBILE PHONE:

FAX:

E-MAIL:

extractactables and leachables summit 2020 · 2020-03-09 · register now to guarantee your space!...

Documents