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Continuous Bioprocessing Barcelona Spain. Continuous Processing in Biotech Production: An alternative to a modern single use, batch, facility ? Thomas Daszkowski, Bayer Technology Services. Agenda. Function and Role of Bayer Technology Services - PowerPoint PPT Presentation

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Continuous Processing in Biotech Production: An alternative to a modern single use, batch, facility ?

Thomas Daszkowski, Bayer Technology ServicesContinuous BioprocessingBarcelona Spain

21.10. 2013, Thomas DaszkowskiPage 1

21. 10. 2013, Thomas DaszkowskiAgendaFunction and Role of Bayer Technology ServicesBiopharmaceutical Market (Trends and Drivers)Current and new Biotech Manufacturing conceptsContinuous ManufacturingConclusionPage 2

Who is Bayer Technology Services (BTS) Bayer Technology Services initiates, implements and supports technological innovations over the long term.

From product and process development through the planning and construction of plants to the automation and optimization of processes.

21. 10. 2013, Thomas DaszkowskiPage 33Trends / Drivers impacting Manufacturing Trends / DriversImpact on ManufacturingRegional Requirements -> local instead of centralizedPersonalized Medicine -> reduced output per drugRapid Enhancements in -> allow for changes, decouple - Cell Biology (Titer) and building from equipment - Technology (Single Use)More Potent Drugs-> reduced output per drugMore Competition-> cost pressure on production will increase

Need for localized, yet cost competitive production units

21. 10. , 2013, Thomas DaszkowskiPage 4Status Quo: Recent Facility AnnouncementsBristol-Myers Squibb (Devens, MA), $750MM, 6x 20,000l bioreactors 2011 timeframe

Pfizer Biotech Campus (Grange Castle, Ireland), 1.8 billion, 6x 12,5000l bioreactors , additional 145M investment announced in Sep 2011.

MedImmune, ( Fredricksburg ), $ 600 Mill., 2011 Facility of the Year Award in the project execution category.

XcellerexannouncessaleofFlexFactoryBio-productionlinetoRPharmfornewmanufacturing facilityinRussia

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2013, Thomas Daszkowski5Newer Facility ConceptsGE Healthcare KUBiohttp://www.GE.comnne pharmaplan (Flexplant)http://www.nnepharmaplan.comMerck Millipore, DSMhttp://www.merckmillipore.comJacobs, CRB,..

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2013, Thomas Daszkowski6Examples of Bayer Activities

Single-Use Systems Functionally Closed ProcessingBall Room ConceptContinuous Manufacturing

MoBiDiKModular, Bio production, Disposable, Konti

Newer Facility Concepts: Bayer Activities2013, Thomas DaszkowskiPage 127MoBiDiK: Project Set-UpMoBiDiKIndustry Academia Consortium (9 partners)Partially Public Funded Project through State of NRW (Germany)Project Start: 1st August 2011Project Duration: 3 years

Continuous, disposable and modular technologies to develop a functionally closed mAb process of the future

funded by:2013, Thomas DaszkowskiPage 8

MoBiDiK : Fully integrated and single use Continuous Manufacturing

2013, Thomas DaszkowskiPage 9Current FacilitiesNewer Facilities ConceptMoBiDiK Concept BatchStainless steelRooms C & D classe.g. 6x 20,000l bioreactorsBatchSingle useRooms C & D class

ContinuousSingle Use

MoBiDiK : Why Continuous Manufacturing ?

2013, Thomas DaszkowskiPage 10MoBiDiK Concept ContinuousSingle Use

Further reduction in Manufacturing Footprint and CapexProcess Robustness (less manual interactions and higher degree of automation)Reduction in Inventory (days at hand)No scale up during drug development required USP DSPDemonstratordisposable, modular & continuous ProcessMoBiDiK Project StructureConceptual DesignConceptual Design Model-based process developmentDownstream ProcessExtraction Chromatography/ Adsorption Membrane TechnologyProtein CrystallizationProtein PrecipitationUpstream ProcessSU-PerfusionSU-Cell retention Pulsed DiafiltrationRQ-Control

Conceptual Design2013, Thomas DaszkowskiPage 11MoBiDiK: Process DesignPage 12 MoBiDiK Update Oct 2013ChromatographyProt AViral InactivationConcentrationFormulationUF/ DFPolishingCapto adhere/ AEXVirus FiltrationDownstream




MoBiDiK Demonstrator Laboratory SCM MoBiDiK Sep, 2013Page 13


3D Layout 1st Floor Production Level BTS 4:3 Template 2010 June 2011Page 14

September 25, 2013, Jrgen MagnusPage 15

Cell culture pilot plant in WuppertalPurposeProduce material for phase 3 clinical trialsDesignStainless steel equipmentFunctionally closed processingFed-batch fermentationOperations are separated in different roomsComparison to facility with traditional design and similar production capacityBiofacility of the futurePurposeProduction for marketDesign100 % S.U. process equipmentClosed processingContinuous processingBallroom productionBuilding Concept5 levels~ 5000 m2 total area~ 1400 m2 cleanroom (class D and C)Building Concept2 levels~ 1200 m2 total area~ 360 m2 cleanroom (class D and C)MoBiDiK ChallengesCompeting with an existing well proven technology platform

GMP readiness of equipment

At / Inline analytics

More complex operation , increase in operator skill set

Regulatory buy in

2013, Thomas DaszkowskiPage 16Conclusions2013, Thomas DaszkowskiPage 17Need for localized, yet cost competitive production units is real

New Single Use batch operated Biotech Facilities are a first response (biggest advantage, technology and mindset readiness)

Conti Manufacturing allows in additionNext step in Footprint and Capex ReductionOne identical platform for Clinical Development and Product LaunchHigh degree of automation and reduction in manual interaction

(biggest challenge; paradigm shift (technology and mindset) in Development and Production)

Acknowledgment:Mobidik Team, BHC GBD, Invite, Bio NRW,..

Thanks for your attentionPage 18 2013, Thomas Daszkowski18The Biopharma Market in numbers Biopharmaceuticals account for 15.6% of total market in 2011Global biopharmaceutical market was valued at $138 billion in 2011Expected to grow to over$320 billion by 2020Growth >10% each yearMonoclonal antibody products are the fastest growing segment 65% of developmental pipelineSource: Levine, bptc consultant and IMS Health

21. 10. 2013, Thomas DaszkowskiPage 1919The Biopharma Market & BRIC countries 21. 10. 2013, Thomas DaszkowskiPage 20

20Continuous Manufacturing: Data PointsApril 2, 2013, Thomas DaszkowskiPage 21

Source: EPSRC,Centre of Innovative Manufacturing ESPRC and Conti ProcessingApril 2, 2013, Thomas DaszkowskiPage 22

ESPRC and Conti Processing contdApril 2, 2013, Thomas DaszkowskiPage 23

Change from batch to continuous processing in pharmaceutical manufacturing will happen soon (Pfizer 2003)(Bio)pharmaceuticalCompanyContinuous (bio)manufacturingRemarkPfizerContinuous Processing in Pharmaceutical Manufacturing

new manufacturing technology of continuous processing involving chemistry in a pipe and continuous extraction (implemented at Pfitzer, Ireland 2009)Matthew J. Mollan Jr., Ph.D. and Mayur Lodaya, Ph.D., Pfizer Inc.Roche/GenentechContinuous wet granulation process using QbD and PAT presented in December 2012 during PDA/EMA conferenceMartin WunderlichGSKIChemE 2012 Award: fully integrated and closely controlled tablet production process Cooperation with Siemens, GEA, Sagentia and academiaNovartis/Sandoz10-year study MIT-Novartis cooperation on small molecule, pilot plant in headquarter started, 5-10 years forecast to convert all Novartis production sitesBernard TroutSanofi/GenzymeContinuous manufacturing will be presented during BPI europe in 2013K. KonstantinovMerck SeronoPilot study for conti downstream presented in BPI Europe meeting Feb 2013Norbert Rasenack, Thomas Linden

Continuous Manufacturing: Data Points contdApril 2, 2013, Thomas DaszkowskiPage 24