PharmaEd Resources, Inc. • 2810 Robeson Park Drive • Champaign, IL 61822tel. 217.721.5774 • web. www.pharmaedresources.com
Aseptic Processing Summit 2020September 21 – 22, 2020
Philadelphia, PAFeaturing Lessons Learned and Case Studies from Industry Experts:
With Representation From:
• A Risk Based Approach to an Environmental Monitoring Assessment
• UsingScientificDatatoassesstheRiskof Sterilizing Filter Flaw Masking and the Need for Pre-use, Post-Sterilization Integrity Testing
• DesigningaRiskBasedCleaningandDisinfectionProgram
• ContinuousMicrobiologicalEnvironmental Monitoring for Aseptic Manufacturing
• Innovations in Aseptic Processing-Opportunities&ChallengesforImplementation
• Single Use Manufacturing Systems – PracticalConsiderations
• AsepticCompoundingin503bIndustry:ChallengesandMitigation
• TerminalSterilizationorBioburdenReduction Processes using Ionizing Radiation
• IsolatorsforCellandGeneTherapy:ClosingtheProcessforATMPs
• NextGenNow-TheFutureofAdvancedTherapy Medicinal Products (ATMP) Facilities
• NewDevelopmentsinLyophilizationandAutomaticVialLoading/Unloading
• Single-Use Technologies Used for Aseptic Processing and Final Filling Applications
• MediaFills/AsepticProcessSimulationand Validation
• ClinicalandSmall-ScaleAsepticManufacturing, a Modular Filling System Approach
• And More!
Pallavi BadkarMedisourceRX
Hite BakerO’Neal, Inc.
Andre ZduncykBausch + Stroebel
ChrisFeeIMA Life N.A.
Jim PolarineSteris
CarolJulichTSI Inc.
LesEdwardsSkan US
LauraMoodySyntegon
William Peterson
Merck
Joe BrowerAseptic Process
Solutions
DawnWatsonMerck
ChuckRayeMillipore Sigma
Jessica Frantz
Sartorius Stedim
With Comprehensive Coverage On:
Regulators in North America and Europe are requiring stricter standards for environmental monitoring systems, facility cleaning and disinfectantqualification,asepticcleanroomoperations,filtration,sterilization,andasepticprocesssimulation(ormediafill).Thistwo-daysummitfeaturesexpertinsightintotherobustasepticprocessingrequirementsfacingtheindustry.PharmaEd’sAsepticProcessingSummitfeaturescomprehensivecoverageontheimplementationandmanagementofthelatestknowledgeinaseptic,barrier,contain-ment,andasepticbestpracticetechnologies.
Aseptic Process Solutions, LLC
Register Now to Guarantee Your Space! Online: www.pharmaedresources.com • Phone: 217.721.5774
Aseptic Processing Summit 2020
Q&A: Ask the Experts
11:10 SingleUseTechnologiesPanelDiscussion
Panel:
• ChuckRaye,MilliporeSigma• Joseph Brower, Aseptic Process Solutions• Jessica Frantz, Sartorius Stedim
Discussants:TheAudience
11:40 Complimentary Networking Lunch
Industry Working Group Update — The Sterile Filtration Quality Risk Management Consortium
1:00 UsingScientificDatatoAssesstheRiskofSterilizing Filter Flaw Masking and the Need for Pre-use, Post-Sterilization Integrity Testing
William Peterson, Associate Director of Engineering: Sterile Product Manufacturing, Merck
This talk summarizes the efforts of the Sterile Filtra-tion Quality Risk Management consortium (“SFQRM”),
ajointprojectbytheParenteralDrugAssociationandtheBioPhorum.Usingobjectivemethodologies,theteamhasgenerated new data shedding light on the risk of filter flawmasking.Thepublicationofamanualofbestprac-tices for pre-use, post-sterilization filter integrity testing willbeannounced,compiledbyfiltrationexpertsacrossthe industry and designed to minimize the risks to sterile productswhenperformingthiscomplexoperation.Rec-ommendationswillbemadefortheuseofscientificdatain process-specific risk assessments on filter integrity testing.
Critical Issues — Risk-Based Approaches to Environmental Monitoring
1:45 A Risk Based Approach to an Environmental Monitoring Assessment
Dawn Watson, Director, Sterile Technology & Commercialization, Merck
An industry collaboration comprising of 20 compa-nies worked on the development of an easy to use standardized risk-based EM approach which im-
provesthelevelofobjectivitywhenidentifyingenviron-mental monitoring locations in cleanrooms, conventional aseptic filling lines,RABS,and isolators.Theapproachwillbedescribedandrecommendationswillbeprovidedfor how the industry could adopt this approach to ensure thathighstandardsforthedesignofarisk-basedEMpro-gramarefollowedinaconsistentmanner.
2:30 Coffee & Networking Break
Monday,September21
8:00 Registration & Complimentary Breakfast & Chairperson’s Welcome
Spotlight on Single-Use Systems & Technologies
8:45 Single-Use Technologies Used for Aseptic Processing and Final Filing Applications
Jessica Frantz, Technology Expert – Aseptic Transfer, Sartorius Stedim North America
Single-Usesystemsarebeingimplementedbymanyend-users in the Biopharmaceutical manufacturing community.Frombagsforstorage&mixingtoasep-
ticconnections&disconnections,theseitemsarebeingused frommedia&buffer prep all theway to final fill-ingapplications.Thispresentationwillgooverthesin-gle-use technologiesavailable today for use inasepticmanufacturing. In addition, the presentationwill coversingle-use systems used for the aseptic transfer of com-ponents and final drug product into theGradeAmanu-facturingspace.Single-Usefillingsystemswillalsobediscussed, showing the details needed for system design toensuresterilityandmaintaindosingaccuracy.
9:25 Single-use Technologies in Aseptic Filling Applications
Chuck Raye, Single Use Final Fill Manager, MilliporeSigma
This presentation will provide an overview of how SU systems are used in final sterilization filtration andasepticfillingprocessestoenableamoreflexi-
bledrugproductmanufacturingprocess.Advancementsin SU technologies such asSU filter designs to enablePUPSIT, packaging of SU filling needles for isolator/RABS filling machines and SU rotary piston pumps will bepresented.
10:05 Coffee & Networking Break
10:30 Single Use Manufacturing Systems — PracticalConsiderations
Joseph Brower, President, Aseptic Process Solutions, LLC
Single use manufacturing systems are widely used in bio-pharmaceutical manufacturing due to theirsafety, convenience,anddesign flexibility. Theyof-
fer many advantages over re-usable systems but caremustbetakenwhenchoosingsingleusesystems.Thereare disadvantages as well including chemical compati-bilityissues,sterilityassurancequestions,supplyinter-ruptions,andquestionsregardingenvironmentalimpact.Careful consideration of the pros and cons will helpdetermine where single use systems are preferred, and whentheymaybethewrongchoice.
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Aseptic Processing Summit 2020
Letters, 483s,andPDATechnicalReportNo. 70sectionswillbecoveredwhichrelatetothetopicsmentioned.
The presentation will focus on industry trends and indus-try best practices based on 20 years of global industryexperiences.
KeyTopicsCovered:
• Industry Regulations• Technologies(Chemistries)• HowtoSelecttheBestChemistry• Application Methods• FrequenciesofSanitizers,Disinfectants,andSporicides• Rotation and Rinsing Strategies
9:30 AdvancedSterileFacilities:OpportunitiesandChallengesfromDesignthroughImplementation
Hite Baker, Principal Process Engineer, O’Neal, Inc.
The journey from design-to-licensure of new ster-ile facilitieswas revolutionizedduring the2000’sbytechnical advancements: modular/ flexible fillers,
barrier systems for product protectionandcontainment,advancing automation, smart robotics, single-use andready-to-use components. As the benefits of AdvancedAseptic Technology multiplied, so also did the challenges during project deliverymultiply. Ownersmust not onlychooseoptimumaseptictechnology,butalsoprogramthefacilitytocreateefficient/compliantlayoutsforgoodflowandcGMPcleanliness.Ownersmust also construct thebuilding, commission it, qualify it, validate and licenseit. In2020, it’smore important thanevernotonlyget thetechnicalscoperight,butalsotocreateanaccuratecostestimate,acontrollablebudgetandamanageablesched-ule. Lessons learned and lively case studieswill showthe opportunities and pitfalls during design, construction andstart-up,andhowtoavoidthebigmistakes.
10:15 Coffee and Networking Break
Research Spotlight — Overcoming Small Batch Aseptic Manufacturing Challenges
10:45 AsepticCompoundinginthe503BIndustry:ChallengesandMitigations
Pallavi Badkar, MS, RPH, BCSCP, Manufacturing Manager, MedisourceRx
TheNECCtragedyinthecompoundingindustryprompt-edCongresstosigntheDrugQualityandSecurityAct(DQSA)with the goal of preventing future tragedies.
The503BOutsourcingFacilitydesignationoriginatedfromtheDQSA.This typeof facility isaprimaryandpreferredmanufacturingsourceofdrugsonshortage.Theyalsomaymanufacturesterileinjectablesfromnon-sterileAPI’sfromthe FDA approved bulk list. The challenge for this entityisthat503B’smustfollowcGMPbutpayersrequestsmallbatchsizesofseveraltypesofdrugspackagedinvariouscontainers. While it is most ideal to employ automatic
3:00 ContinuousMicrobiologicalEnvironmentalMonitoring for Aseptic Manufacturing
Carol Julich, Contamination Specialist, TSI Inc.
Biofluorescentparticlecounters (BFPC)offeranal-ternativemethod for viable air testing that not onlymonitorscontinuously,butprovidesreal-timeresults
with improved detection. This provides better under-standing of the aseptic manufacturing process to make moreinformedqualitydecisions.Inaddition,theyremovethe contamination risk from the environmental monitor-ingprocessbecausenointerventionsarerequired.Thispresentationwill review the technology used by theseinstruments and how to use them to improve your process andreducerisk.
Q&A: Ask the Experts
3:35 Environmental Monitoring & Sterile Product ManufacturingPanelDiscussion
Panel:
• William Peterson, Merck• DawnWatson,Merck• CarolJulich,TSI,Inc.
Discussants:TheAudience
4:05 TerminalSterilizationorBioburdenReductionProcesses Using Ionizing Radiation
Betty Howard, Senior Radiation Sterilization Manager, Applied Sterilization Technologies, STERIS Corporation
This presentation will review Ionizing radiation pro-cesses (Gamma, Electron Beam and X Ray). What
they are, how they work, their similarities and differenc-es,theirProsandConsvs.othersterilizationmodalities,key considerations in using them and applications in Pharmaceuticalproductsandprocesses.
4:50 Networking Happy Hour
Tuesday,September22
8:00 Complimentary Breakfast
8:45 DesigningaRiskBasedCleaningandDisinfectionProgram
Jim Polarine, Jr., Senior Technical Service Manager, STERIS Corporation
This presentation will cover the current industry trendsandbestpractices indisinfectantglobal reg-ulations, rotation, disinfectant application methods,
application frequencies, residue removal and rinsing strategies,andacasestudywillbecovered thatexam-inesCAPAinvestigationswithfungalandbacterialsporesin cleanroom operations. Annex I (Draft 2019),Warning
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Aseptic Processing Summit 2020
2:00 IsolatorsforCellandGeneTherapy:Closing the Process for ATMPs
Les Edwards, Vice President, Technology & Business Development, SKAN US, Inc.
It is well acknowledged that aseptic fill-finish opera-tions,evenforsmallbatchprocessing,ispreferredtobeperformedwithinanisolator.Manyupstream,cell
expansionanddownstreamoperationsalsobenefitfroma more secure aseptic environment to improve quality, environmental control, and reduce the chance of product contamination. The challenge is to implement isolatorsin operations that are traditionally performed in clean-roomsandbiosafetycabinets.Thefacilityandoperation-alsavingscanalsobesignificant.Therighttechnologiesneed to be deployed to allow for easy, validatable andrapid transfers for temperature sensitive items, and in-tegrationof incubationandcentrifugationequipment inadditiontotraditionallabinstrumentation.
2:40 Coffee and Networking Break
3:00 NewDevelopmentsinLyophilizationandAutomaticVialLoading/Unloading
Chris Fee, Product and Sales Manager, IMA Life North America, Inc.
There are numerous advanced technologies beingdeveloped for and incorporated into freeze drying processes (a.k.a. lyophilization) to improve product
homogeneity,increaseefficiency,andreducecGMPrisk.In this presentation we will explore various tools and techniques,anddiscusswhatthefuturewillbring.
Q & A — Ask the Experts
3:40 ClosingPanelDiscussion—ThePresent&Future of Aseptic Fill-Finish Operations
Panelists:
• LauraMoody,SyntegonPharmaTechnology,Inc.• LesEdwards,SKANUS• ChrisFee,IMALifeN.A.
4:20 Close of Program
filling machines to ensure sterility assurance of asepticprocessingof drugs, these technologiesarecost prohib-itive, inefficient in changeover, and often not flexible incontainer choice. Therefore, manual aseptic processing(MAP) is often employed in this industry as well as in tra-ditionalcompoundingpharmacies.WhileMAPallowsforanincreasedflexibilityofthecontainersusedanddrugfor-mulations produced, there is a high risk of contamination fromhumaninterventions.
The goal of this presentation is to discuss various ap-proaches to mitigate the challenges of manual aseptic processing using best practice aseptic techniques toensuresterilityduringcriticalhumaninterventions.Se-lectsmallbatch fillingand finishingequipment,closedready-to-fill systems, and single-use aseptic processing supplieswillalsobediscussedasaidsinachievingste-rilitywithMAP. Finally, the importance of sourcing in-jectablegradeAPI’sasamanufacturer’sresponsibilityinpreventingadversedrugeventswillalsobediscussed.
11:30 ClinicalandSmall-ScaleAsepticManufacturing,a Modular Filling System Approach
Andre Zdunczyk, Sales Manager, Bausch + Stroebel
The trend in Bio-Pharmaceutical processing is to-wards smaller and personalized batches of medi-cines.Brining a diversemix of therapies packaged
in different delivery methods to the market is one of the main challenges in the pharmaceutical industry. Thispresentation will cover the transition of components into afillingIsolator,roboticTUBandnesthandling,theuti-lizationofasingleuseproductpathwith the flexibilityto change containers and filling methods using a single modularasepticpackagingsystem.
12:10 Complimentary Networking Lunch
Technology Spotlight — The Present & Future of Aseptic Fill-Finish Operations
1:20 HowtheFutureofFinalFillDemandsFuture-focusedSolutions:ACaseStudy
Laura Moody, Ph.D., Product Manager – Primary Packaging, Pharma Liquid Packaging, North America, Syntegon Pharma Technology, Inc.
Necessity is the mother of invention.When a majorbiopharmaceutical manufacturer’s R&D facility neededa new fill-finish line to support preclinical and clinicaldevelopment of their advanced therapies pipeline, the equipment industry landscape was not well suited to their requirements. After striking an innovative partnershipwith Bosch Packaging Technology (now Syntegon Pharma Technology),anewmachineconceptwasborn.Thispre-sentation will discuss the journey from design to delivery, highlightingbothtechnologicaladvancesinthefield(i.e.barriersystems,automation,robotics,flexibilityindosageform,etc.)aswellaschallengesovercomealongtheway.
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Aseptic Processing Summit 2020
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VENUE INFORMATION:
Event Dates: September 21– 22, 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.
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