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

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Presentation on theme: "Continuous Processing in Biotech Production: An alternative to a modern single use, batch, facility ? Thomas Daszkowski, Bayer Technology Services Continuous."— Presentation transcript:

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

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

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 DaszkowskiPage 3

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 DaszkowskiPage 4

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.  Xcellerex announces sale of FlexFactory®Bio- production line to R ‐ Pharm for new manufacturing facility in Russia Page 5 2013, Thomas Daszkowski

6 Newer Facility Concepts  GE Healthcare KUBio™  nne pharmaplan (Flexplant)  Merck Millipore, DSM  Jacobs, CRB,….. Page 62013, Thomas Daszkowski

7 Examples of Bayer Activities  Single-Use Systems  Functionally Closed Processing  Ball Room Concept  Continuous Manufacturing MoBiDiK Modular, Bio production, Disposable, Konti Cleanroom-Paradigm-for-Biopharmace/ArticleStandard/Article/detail/733336 Newer Facility Concepts: Bayer Activities 2013, Thomas DaszkowskiPage 12

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

9 MoBiDiK : Fully integrated and single use Continuous Manufacturing 2013, Thomas DaszkowskiPage 9 Current Facilities Newer Facilities Concept MoBiDiK Concept Batch Stainless steel Rooms C & D class e.g. 6x 20,000l bioreactors Batch Single use Rooms C & D class Continuous Single Use

10 MoBiDiK : Why Continuous Manufacturing ? 2013, Thomas DaszkowskiPage 10 MoBiDiK Concept Continuous Single Use 1. Further reduction in Manufacturing Footprint and Capex 2. Process Robustness (less manual interactions and higher degree of automation) 3. Reduction in Inventory (days at hand) 4. No scale up during drug development required

11 USP DSP Demonstrator disposable, modular & continuous Process MoBiDiK – Project Structure Conceptual Design Model-based process development Downstream Process Extraction Chromatography/ Adsorption Membrane Technology Protein Crystallization Protein Precipitation Upstream Process SU-Perfusion SU-Cell retention Pulsed Diafiltration RQ-Control Conceptual Design 2013, Thomas DaszkowskiPage 11

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

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

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

15 September 25, 2013, Jørgen MagnusPage 15 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 Comparison to facility with traditional design and similar production capacity Biofacility of the future Purpose Production for market Design 100 % S.U. process equipment Closed processing Continuous processing Ballroom production Building Concept 5 levels ~ 5000 m2 total area ~ 1400 m2 cleanroom (class D and C) Building Concept 2 levels ~ 1200 m2 total area ~ 360 m2 cleanroom (class D and C)

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 DaszkowskiPage 16

17 Conclusions 2013, Thomas DaszkowskiPage 17 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 degree of automation and reduction in manual interaction (biggest challenge; paradigm shift (technology and mindset) in Development and Production)

18 Acknowledgment: Mobidik Team, BHC GBD, Invite, Bio NRW,.. Thanks for your attention Page 18 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, bptc consultant and IMS Health 21. 10. 2013, Thomas DaszkowskiPage 19

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

21 Continuous Manufacturing: Data Points April 2, 2013, Thomas DaszkowskiPage 21 Source: EPSRC,Centre of Innovative Manufacturing

22 ESPRC and Conti Processing April 2, 2013, Thomas DaszkowskiPage 22

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

24 „Change from batch to continuous processing in pharmaceutical manufacturing will happen soon“ (Pfizer 2003) (Bio)pharmaceutical Company Continuous (bio)manufacturingRemark Pfizer Continuous 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/Genentech Continuous wet granulation process using QbD and PAT presented in December 2012 during PDA/EMA conference Martin Wunderlich GSK IChemE 2012 Award: fully integrated and closely controlled tablet production process Cooperation with Siemens, GEA, Sagentia and academia Novartis/Sandoz 10-year study MIT-Novartis cooperation on small molecule, pilot plant in headquarter started, 5-10 years forecast to convert all Novartis production sites Bernard Trout Sanofi/Genzyme Continuous manufacturing will be presented during BPI europe in 2013 K. Konstantinov Merck Serono Pilot study for conti downstream presented in BPI Europe meeting Feb 2013 Norbert Rasenack, Thomas Linden       Continuous Manufacturing: Data Points cont‘d April 2, 2013, Thomas DaszkowskiPage 24

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