Aseptic Processing 2020 - Pharma-Ed Resources, Inc. · 2020-02-26 · processing of drugs, these technologies are cost prohib-itive, inefficientin changeover, and often not flexiblein

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.



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



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 2020 - Pharma-Ed Resources, Inc. · 2020-02-26 · processing of drugs, these technologies are cost prohib-itive, inefficientin changeover, and often not flexiblein