Tuesday, April 2610:30am – 11:30am ROUNDTABLE - Deciding on Single-Use vs. Stainless Steel Strategy; What the CMOs Know that Biopharma Needs (Part 2) Chairperson: EricS.Langer,Managing Partner,BioPlanAssociates Panelists: DanielVellom,Senior Director, Global Technology Innovation,SanofiPasteur SueBehrens,Senior Director, Process Technology,IPS–IntegratedProcessSolutions,Inc. BillHartzel,Director, Strategic Execution,CatalentPharmaSolutions JohnWard,Vice President,Engineering,Patheon

11:30pm-12:00pm Qualification and Application for Single-Use In-Line Sensors in Bioprocessing Speaker: JimFurey,General Manager,PendoTech

12:00pm-1:00pm ROUNDTABLE - Single-Use Harmonization Town Hall – Coordination of SUS Standards and Best Practice Efforts Chairperson: JamesD.Vogel,Founder and Director, TheBioProcessInstitute Panelists: MikeJohnson,Business Development Engineering Manager,Entegris

1:00pm-1:20pm Benchtop Scale Single-Use Bioreactor (SUB) System for Recombinant Protein Production Speaker: MarkArjona, Product Manager, Biotechnology

1:20pm-1:40pm The Evolution of Upstream Processing: Mitigating Risk through Single-Use and Cell Culture Technologies Speaker: JoshHays,Senior Global Sales Development Consultant, Upstream Portfolio,MilliporeSigma

1:40pm-2:00pm Significant Technology Advances Enabling Integrated Continuous BioProcessing Speaker: PeterLevison, Senior Director,PallLifeSciences

2:20pm-2:40pm Best Practices for Developing Single-Use TFF Steps Speaker: ParvezKhan,System Sales Specialist,ParkerdomnickhunterFiltrationNorthAmerica

Wednesday, April 27 11:00am-11:20am Delivering Unique Sterile Primary Container Closures with Advanced Aseptic Manufacturing Speaker: BillHartzel,Director – Strategic Execution,CatalentPharmaSolutions

11:20am-11:40am Minimizing Particulate Contamination during Sterile Filling Speaker: EduardNoguera,Managing Director,Grifols

11:40am-12:00pm Utilizing Environmental Monitoring to Ensure Facility State of Control Speaker: JamesD.Vogel,Founder and Director,TheBioProcessInstituteter Hall – Finalist Presentations and Best Poster Award Thursday, April 23

Official Guide

BPI TheaTer and PosTer hall (BooTh 3861) exhIBIT hall

TRaiNiNG SYMPOSiuMGetting the Most in Training for New Technologies12:00pm – 2:00pm

12:00pm – 12:10pm Introductory Remarks Speaker: GaryGilleskie,PhD,Director Operations,BiomanufacturingTrainingandEducationalCenter(BTEC),NorthCarolinaStateUniversity Speaker: BrianCaine,Co-Founder and Publisher,BioProcessInternational

12:10pm – 12:30pm Process-Oriented Training in Single-Use Technology Speaker: GaryGilleskie,PhD,Director Operations,BiomanufacturingTrainingandEducationalCenter(BTEC),NorthCarolinaStateUniversity

12:30pm – 12:50pm Effective Theory-Based Training for Operators Speaker: DavidYarley,Director of Bioprocess Training and Validation Academy,FujiFilmDioSynthBiotechnologies

12:50pm – 1:10pm The Challenge of Automation Competency Speaker: ScottSommer,Technical Fellow – Automation and Controls,Renmatix

1:10pm – 1:30pm Beyond Read and Understand – Moving Training from Compliance to Performance Speaker: ChadCooper,Director of Manufacturing,Biogen

PANEL DISCUSSION: How Training Investments Pay Off Moderator: JamesD.Vogel,Founder and Director,TheBioProcessInstitute Panelists: GaryGilleskie,PhD,Director Operations, Biomanufacturing Training and Educational Center (BTEC),NorthCarolinaStateUniversity DavidYarley,Director of Bioprocess Training and Validation Academy,FujiFilmDioSynthBiotechnologies ScottSommer,Technical Fellow – Automation and Controls,Renmatix ChadCooper,Director of Manufacturing,Biogen

To the BPI Theater, Speakers, and Poster Hall Awards Program

Sponsored by

Presenting Companies

www.bioplanassociates.com

Biopharma Market AnalysisTo Grow Your Business…26 years providing bioprocessing, life science, biosimilars research, data, and publications.BioPlan Associates, Inc.offersunbiasedstrategicmarketinformationandanalysisrequiredtomakemoreeffectivebusinessdecisions.Informationproductsincludecustommarketstudies,strategicanalyses,databases,quantitativeandqualitativeresearch,published

industryreports,whitepapers,andtextbooks.Weprovidetrustedmarketanalysis,basedonthephilosophythatlong-termpartnershipsensureourclients’success.

www.bioprocessinstitute.com

Expert Navigators for the Complex World of Bioprocessing

Dayinanddayoutat The BioProcess Institute,wehelpbioprocessendusers,suppliersandorganizationsnavigatetheindustrytomakebetterdrugs.Wehavetheuniqueabilitytofindtherightbalancebetweenscience,risk,andregulationsduetoourexpertiseandourinnovativeconsulting,testing,andtrainingservices.Everybodywins.

www.custombiogenics.com

Custom BioGenic Systems Your “Complete Solution” Custom BioGenic Systemsprovides acompletesolutionforfreezingandstoringcelllinesandbiologicals.Benchtopandhighcapacitycontrolledratefreezerssafelyfreezeyoursamplesatcontrolledratetoincreasecellviability.OurpatentedIsothermalliquidnitrogenfreezersareknownworldwideforstoringsamplesatliquidnitrogentemperatureswithnoliquidnitrogencontact.VersAlertoffersawiredorwirelessremoteassetmonitoringsolution.Receivenotificationwheneveryoursensitiveequipmentexceedsyourspecifiedparameters.

BooTH #1027

www.distekinc.com

BooTH #2735

Creating A StirFromthecompanythathasbroughtyou40yearsofexcellenceinpharmaceuticallaboratoryinstrumentation,Distek, Inc.isproudtointroducetheBIOne Single-Use Bioreactor System.Convertyourexistingbenchtopglassbioreactortoasingle-usebioreactor. TheBIOnewillmoldtoandmimicyourexistingglasssystemallowingyoutocontinueusingyourexistingcabinet,probes,motor,heatingblanket,waterjacketandrecipes.AllmaterialsareUSPClassVI,animalderivativefreeandutilizedinexistingsingle-useproducts.

www.catalent.com

Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, consumer health and global clinical supply services. Withover80yearsservingtheindustry,Catalenthasprovenexpertiseinbringingmorecustomerproductstomarketfaster,enhancingproductperformanceandensuringreliableclinicalandcommercialproductsupply.Catalentemploysapproximately8,700people,includingover1,000scientists,at31facilitiesacross5continents, andinfiscal2015generatedmorethan$1.8billioninannualrevenue.CatalentisheadquarteredinSomerset,N.J.Formoreinformation, visitwww.catalent.com

BooTH #1546

www.btec.ncsu.edu

The Golden LEAF Biomanufacturing Training and Education Center (BTEC)BTECisaunique,cross-disciplinaryinstructionalcenterthatprovideseducationalandtrainingopportunitiestodevelopskilledprofessionalsforthebiomanufacturingindustry.Italsoprovidesbioprocessdevelopmentandanalyticalservicestoawiderangeofcustomersfromacademiaandindustry.

Presenting Companies

www.pall.com/biopharm

Continuously Improving BioprocessesPall Life Sciencesprovidescriticalfluidmanagementsolutionstogloballifesciencesandindustrialmanufacturingcustomers.ThebiopharmdivisionofPallLifeSciencesfeaturesanunmatchedportfoliooftraditionalandsingle-useproductswithcustomservicesupportfromR&Dtoclinicalphasestoproduction.Palliscommittedtocontinuouslyimprovingbioprocessestoenableuserstoadvanceglobalhealthwithsafe,environmentallyresponsibletechnologies.

BooTH #2815

www.bioprocessintl.com

BooTH #3861

The Premier Scientific Publication to the Biopharmaceutical IndustryTheKeytoeffectiveproductmarketingistoensureyourexpertiseandsolutionsarewellpositionedwithinandsurroundedbyscientificinformationyourcustomersaremostinterestedin.ThisiswhereBioProcess Internationalexcels.Thisisourexpertise.PartnerwithBPItocreateacustomprogramthatperfectlydeliversyoursolutionstothedecisionmakersthatneeditmost.

www.emdmillipore.com/interphex

BooTH #2841

Meet the New Face of EMD Millipore at INTERPHEX 2016ThelifesciencebusinessofMerck KGaA,Darmstadt,Germany,whichoperatesasMilliporeSigmaintheUnitedStatesandCanada,offersabroadrangeofproductsthatspanfromresearchanddevelopmenttoproduction.Visitbooth#2841tolearnhowournewproductinnovationswillhelpyousimplifyyourmanufacturingprocesses,allowingyoutoadvanceyourmoleculestomarketfasterandmorecosteffectively.

www.parker.com/dh-bioprocessing

BooTH #3177

Engineering Your Success in Single-Use BioprocessingAsadivisionofParkerHannifinCorporation,Parker domnick hunter bringsmotionandcontroltobioprocessing.Ourhigh-puritysolutionsspeedupdevelopmenttimes,increaseefficiencyandsafety,andenablereproducibleproductquality.Wecombinefiltration,bioprocesscontainers,overmoldedmanifolds,single-usesensorsandSciLog®bioprocessingsystemsintoautomatedsingle-usesolutionsfornormalflowfiltration,tangentialflowfiltration,bioreactormaintenance,meteringanddispensing.Stopbybooth#3177tofindouthowwecancreateyoursingle-usesolution.

www.pendotech.com

In-line Single Use Process Sensors and Process Development SystemsPendoTECHofferslow-cost, singleusein-linesensorsfor pressure,temperature,conductivity,UVabsorbance&flow(thatarealsorobustenoughforre-use!).Theyhavecomplementarymonitors/transmittersandaretargetedtowardsbiotechprocessdevelopmentandmanufacturing.Alsoavailableareadvancedsystemstargetedtowardsbioprocessdevelopmentwithcompleteprocessautomationanddatacollectionandbuilt-inOPCdataservers.

BooTH #3461

www.grifols.com

BooTH #1738

Specialized in Biotech and Sterile Manufacturing ProcessesGrifols Engineeringoffersconsultancyandengineeringservices aswellasmachineryforthebiotechindustry.

MACHINERY:Specificmachineryforbiotechnologicalandhemoderivativesector,(asepticfilling,ultrafiltration,fermentation,chromatography,etc).TailormademachinerydesignandconstructionfortheBiotechindustry.

ENGINEERING:Biotechprocessengineeringandprojectmanagement

2016 Poster Hall Presentations

BioProcess Equipment Authors Company/Organization

Successful Sterile Filtration of a Microfluidized Oil in Water Emulsion MarthaFolmsbee,RossTurmell PallCorporation

Considerations for Implementing Single Use Filling Systems DenaFlamm,AnneHansen,JosephCianciolo,JamesVigna,BrianPereira BOSCH

High Performance Mixing: Evolution from Stainless Steel to Single Use AnneHansen MilliporeSigma

Addressing Microbial Contamination in Process Equipment ElizabethRivera STERISCorporation

Considerations for Cleaning Validation When Using Automated Washing Systems OlivierVanHoutte,PaulLopolito STERISCanadaCorporation

Optimizing Single-Use Manufacturing Operations in Biomanufacturing JeffOdum,ErichBozenhardt,ChristianEstes, EricFranson,MarckWitcher IPS-IntegratedProjectServices,LLC

Sampling Aseptically to Reduce Bioburden and Biofilm Formation per PDA TR No.69 CharlesMeadows,Bobbi,Allen SartoriusStedimBiotech

Scalability of MilliporeSigmas Mobius™ Single-use Bioreactor Systems AmyWood,JaneRing EMDMillipore

GSF™ Grifols Sterile Filling OriolArgemi,MrieLaureBelien GrifolsEngineeringS.A.

Two Phase Optical System as a Powerful Platform for Continuous Development of Clinical Point-of-Care in Vitro Diagnostic Tests Tsang-BinTzeng TAPMedicalsInc.

Characterization of Silicone Tubing – Effect of Pressure and Irradiation on Tubing Diameter CsillaKollar,Pietro,Perrone,AndrewDiehl,ErnestJenness DowCorningCorporation

Centrifugal Partitioning Liquid Chromatography RobDriscoll RobatelInc.

Comparative Assessment of BioProcess Gasket Service Life JamesDeanVogel,MaureenEustis TheBioProcessInstitute

BioProcess Liquid Flow Meters: Technology Overview JohnBenson,DennisAnnarelli,JamesFurey PendoTECH

The Lynx CDR Connector: Enabling Multiple Sterile-to-Sterile Wet Connections, Disconnections & Reconnections KaraDer MilliporeSigma

ZeroCon™ The New, Patented, 100% Stainless Steel Connection for Safe and Rapid Connection of Tube Systems MartinNeth DockweilerAG

Case Study: Modernized In-House Stopper Processing and Aseptic Transfer of Sterile Components JessicaFrantz Sartorius

Pilot Fermenter for Highly Flexible Upstream Processing in R&D and Pre-Clinical Manufacturing KlausSchreiber BoschPackagingTechnology

Tapered Needle Technology Improves Injection Flow Rate MitsuruTakahashi TerumoMedicalCorporation

Aflex Hose Ltd - Innovation Not Imitation SamLee AflexHoseLtd

Facility Design/Contract Services Flexible Facility Designs Complimenting Continuous Processing DennisPowers G-CONManufacturing

Integrating IE and LSS Techniques to Right-Size Your Facility NiranjanKulkarni CRB

Site Comparison for Insourcing of Biologic Production TheodoreCohen,LarissaEsposito IPS-IntegratedProjectServices,LLC

Optimizing Biomanufacturing Operations: Effective Single Use Process Decisions ChristianEstes,EricFranson,LarissaEsposito IPS-IntegratedProjectServices,LLC

Solving the Lab to Production Milling Scale Up Enigma: Which Size Reduction Equipment is Best and How is Scalability Assured? WilfSanguesa QuadroEngineering

Feasibility Study for Insourcing Manufacturing Capability as Compared to Continued Usage of CMO TheodoreCohen,LarissaEsposito IPS-IntegratedProjectServices,LLC

Test Cannabis Oil Separately and in Combination with STCF or SLO for the Treatment of Respiratory Diseases FrederickFerri,DavidPhaneuf,StevenSwartz NaturesComfortMeds

Process Automation/Packaging/Logistics Supply Chain and Logistics Optimization AlexanderX.Felix UniversityofTurabo

A Three Dimensional Interface for an Innovative Process in Facility Design DanielDavis,DarynRolling,LarissaEsposito IPS-IntegratedProjectServices,LLC

Automation integration of Modular, Portable & Disposable Bio-processing Equipment JoesphO’Reilly,LarissaEsposito IPS-IntegratedProjectServices,LLC

If You’re Not Keeping Score, You’re Just Practicing JamesDeanVogel,MaureenEustis,MelanieCerullo TheBioProcessInstitute

Answering Key Design Questions Utilizing SuperPro and SchedulePro Process Modeling Softwares in Conceptual Design TheodoreCohen,LarissaEsposito IPS-IntegratedProjectServices,LLC

OCS Traceable Quality System (TQS) - The Guarantee For Process & Product Safety SheridenDemont,MartinKuehn OCSCheckweighers,Inc.

Pyclear™ Protection: A Major Innovation Protecting Patients from the Adverse Effects of Preservatives LoicMarchin,ChristineRoques Pylote

Improving APIs Particle Size Distribution Targets - Is There a Better Way? WilfSanguesa QuadroEngineering

Innovative Approach to Conical Milling Addresses Pharmaceutical Oral Solid Dosage’s Major Challenges With Heat Sensitive Products, Particle Size Distributions and Product Contamination WilfSanguesa QuadroEngineering