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Continuous Bioprocessing Barcelona Spain

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

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Continuous Bioprocessing Barcelona Spain

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  1. ContinuousBioprocessingBarcelona Spain Continuous Processing in Biotech Production: An alternative to a modern single use, batch, facility ? Thomas Daszkowski, Bayer Technology Services 21.10. 2013, Thomas Daszkowski

  2. Agenda • Function and Role of Bayer Technology Services • Biopharmaceutical Market (Trends and Drivers) • Current and new Biotech Manufacturing concepts • Continuous Manufacturing • Conclusion 21. 10. 2013, Thomas Daszkowski

  3. 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 Daszkowski

  4. Trends / Drivers impacting Manufacturing • Trends / DriversImpact on Manufacturing • Regional Requirements -> local instead of centralized • Personalized Medicine -> reduced output per drug • Rapid Enhancements in -> allow for changes, decouple - Cell Biology (Titer) and building from equipment • - Technology (Single Use) • More Potent Drugs -> reduced output per drug • More Competition -> cost pressure on production will increase • Need for localized, yet cost competitive production units 21. 10. , 2013, Thomas Daszkowski

  5. Status Quo: Recent Facility Announcements • Bristol-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. • Xcellerexannouncessale of FlexFactory®Bio-productionline to R‐Pharm for newmanufacturing facility in Russia http://www.xcellerex.com/pdf/Xcellerex_rpharm.pdf 2013, Thomas Daszkowski

  6. Newer Facility Concepts • GE HealthcareKUBio™ • http://www.GE.com • nne pharmaplan (Flexplant) • http://www.nnepharmaplan.com • Merck Millipore, DSM • http://www.merckmillipore.com • Jacobs, CRB,….. 2013, Thomas Daszkowski

  7. NewerFacilityConcepts: Bayer Activities • Examples of Bayer Activities • Single-Use Systems • Functionally Closed Processing • Ball Room Concept • Continuous Manufacturing • MoBiDiK • Modular, Bio production, Disposable, Konti 2013, Thomas Daszkowski Page 12

  8. MoBiDiK: Project Set-Up • MoBiDiK • Industry – Academia Consortium (9 partners) • Partially Public Funded Project through State of NRW (Germany) • Project Start: 1st August 2011 • Project Duration: 3 years funded by: Continuous, disposable and modular technologies to develop a functionally closed mAb process of the future 2013, Thomas Daszkowski

  9. MoBiDiK : Fully integrated and single use Continuous Manufacturing CurrentFacilities MoBiDiKConcept NewerFacilitiesConcept • Batch • Single use • Rooms C & D class • Continuous • Single Use • Batch • Stainlesssteel • Rooms C & D class • e.g. 6x 20,000l bioreactors 2013, Thomas Daszkowski

  10. MoBiDiK : Why Continuous Manufacturing ? • Further reduction in Manufacturing FootprintandCapex • ProcessRobustness (lessmanualinteractionsandhigherdegreeofautomation) • Reduction in Inventory (daysathand) • Noscaleupduringdrugdevelopmentrequired MoBiDiKConcept • Continuous • Single Use 2013, Thomas Daszkowski

  11. MoBiDiK – Project Structure USP DSP • Demonstrator • disposable, modular & continuous Process Conceptual Design 2013, Thomas Daszkowski

  12. MoBiDiK: Process Design Upstream Perfusion Clarification Chromatography Prot A Concentration Downstream Formulation UF/ DF Viral Inactivation Polishing Capto adhere/ AEX Virus Filtration • MoBiDiK – Update • Oct 2013

  13. MoBiDiK – Demonstrator Laboratory A A DSP USP • SCM MoBiDiK • Sep, 2013

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

  15. Comparison to facility with traditional design and similar production capacity Cell culture pilot plant in Wuppertal Purpose Produce material for phase 3 clinical trials Design Stainless steel equipment Functionally closed processing Fed-batch fermentation Operations are separated in different rooms Biofacility of the future Purpose Production for market Design 100 % S.U. process equipment Closed processing Continuous processing Ballroom production Building Concept 2levels ~ 1200 m2 total area ~ 360 m2 cleanroom (class D and C) Building Concept 5 levels ~ 5000 m2 total area ~ 1400 m2 cleanroom (class D and C) September 25, 2013, Jørgen Magnus

  16. MoBiDiK – Challenges • Competing 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 Daszkowski

  17. Conclusions • Need 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 addition • Next step in Footprint and Capex Reduction • One identical platform for Clinical Development and Product Launch • High degreeofautomationandreduction in manualinteraction • (biggest challenge; paradigm shift (technology and mindset) • in Development and Production) 2013, Thomas Daszkowski

  18. Acknowledgment:Mobidik Team, BHC GBD, Invite, Bio NRW,..Thanks for your attention 2013, Thomas Daszkowski

  19. The Biopharma Market in numbers • Biopharmaceuticals account for 15.6% of total market in 2011 • Global biopharmaceutical market was valued at $138 billion in 2011 • Expected to grow to over $320 billion by 2020 • Growth >10% each year • Monoclonal antibody products are the fastest growing segment 65% of developmental pipeline Source: Levine, bptcconsultantand IMS Health 21. 10. 2013, Thomas Daszkowski

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

  21. Continuous Manufacturing: Data Points Source: EPSRC,Centreof Innovative Manufacturing April 2, 2013, Thomas Daszkowski

  22. ESPRC and Conti Processing April 2, 2013, Thomas Daszkowski

  23. ESPRC and Conti Processing cont‘d April 2, 2013, Thomas Daszkowski

  24. Continuous Manufacturing: Data Points cont‘d „Change frombatchtocontinuousprocessing in pharmaceuticalmanufacturing will happen soon“ (Pfizer 2003)       April 2, 2013, Thomas Daszkowski

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