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Continuous Bioprocessing Barcelona Spain

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Presentation on theme: "Continuous Bioprocessing Barcelona Spain"— Presentation transcript:

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

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

4 Trends / Drivers impacting Manufacturing
Trends / Drivers Impact 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 , 2013, Thomas Daszkowski

5 Status Quo: Recent Facility Announcements
Bristol-Myers Squibb (Devens, MA), $750MM, x 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., 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 2013, Thomas Daszkowski

6 Newer Facility Concepts
GE Healthcare KUBio™ nne pharmaplan (Flexplant) Merck Millipore, DSM Jacobs, CRB,….. 2013, Thomas Daszkowski

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

8 MoBiDiK: Project Set-Up
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
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 2013, Thomas Daszkowski

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

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

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

13 MoBiDiK – Demonstrator Laboratory
USP DSP • 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 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) 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 degree of automation and reduction in manual interaction (biggest challenge; paradigm shift (technology and mindset) in Development and Production) 2013, Thomas Daszkowski

18 Acknowledgment: Mobidik Team, BHC GBD, Invite, Bio NRW,
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 % of developmental pipeline Source: Levine, bptc consultant and IMS Health , Thomas Daszkowski

20 The Biopharma Market & BRIC countries
, Thomas Daszkowski

21 Continuous Manufacturing: Data Points
Source: EPSRC,Centre of 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
(Bio)pharmaceutical Company Continuous (bio)manufacturing Remark 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 „Change from batch to continuous processing in pharmaceutical manufacturing will happen soon“ (Pfizer 2003) April 2, 2013, Thomas Daszkowski

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