official guide to the bpi theater, speakers, jim furey, general manager, pendotech 12:00pm-1:00pm...
TRANSCRIPT
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