Morten Munk NNE Facility of the Future: Concepts and biopharmaceutical mega-trends

Transcription

1 Morten Munk NNE Facility of the Future: Concepts and biopharmaceutical mega-trends December 20 th, 2017 Tours, France

2 Focused pharma engineering An international company specialised in pharma engineering We bring best practices to our customers 3,000 projects globally / year We are supporting our customers globally and on local sites 30% pharma consulting 30% restructuring and facility upgrades 40% new production facilities 15 Office locations worldwide 2,000 professionals We enable pharma companies to deliver on demand 2

3 TRENDS A LITTLE QUIZ 3

4 Trends Multi product - flexible facilities Hybrid facilities 2-8 times 15K SS 2-8 times 2K SUS SS and SUS Closed processing Robotics Modular design Local manufacturing (and development) in emerging markets 4

5 Trends cont. Tech Transfer Continuous processing Control Strategy Devices Level 1 Real-time automatic control + Flexible process parameters to respond to the variability in the input material attributes Level 2 Reduced end product testing + Flexible critical material attributes and critical process parameters within design space Level 3 End product testing + tightly constrained material attributes and process parameters Environmental impact ADC s 5

6 THE NEW PHARMA REALITY 6

7 The New Pharma Reality The new pharma reality Old Focus on manufacturing speed New Focus on change-over speed 7

8 Build in flexibility Process level flexibility Suite configuration flexibility Operations flexibility Site and integration flexibility Investment flexibility 8

9 BASIC PROJECT CONSIDERATIONS 9

10 Product Supply Options 1. Get all product produced at CMO s 2. Co-invest in construction of new facilities together with a CMO 3. Build own facility covering all or a portion of the expected demand 10

11 What comes first Facility consideration Layout Classification Segregation HVAC Equipment Process Closed / open SS / SUS Organisation People and processes Procedures SOP s, gowning, planning Flow People, Raw Mat, Waste Automation, training 11

12 What comes first Facility consideration Layout Classification Segregation HVAC Equipment Process Closed / open SS / SUS Organisation People and processes Procedures SOP s, gowning, planning Flow People, Raw Mat, Waste Automation, training 12

13 SINGLE USE AND THE HYBRID APPROACH 13

14 Enablers for flexible manufacturing Single use technology CIP/SIP STAINLESS STEEL SINGLE USE 1000 L 350 L 14

15 Comparing stainless steel and single use Scale Capital investment CAPEX Capital operational costs OPEX Minimise risk of (cross) contamination Time for establishing a facility Flexibility Change over time Commission and qualification Leachables Ease to tech transfer Sustainability Stainless steel Single Use 15

16 Customer reports 16 Based on publicly available data collected by Parrish Galliher, GE Healthcare

17 Calculation Between SS and SUS Facility Costs Calculation between Stainless Steel and Single Use Facility Total Cost of Supply ($M) TOTAL COST OF SUPPLY COMPARISON $ $ $ $ $ $ $ $ $ End of P3 End of P2 POS=90% POS=58% POS=26% SS facility is first cheaper than SU Facility after 10 years based on the figures indicated SUB Case SS Case $50.00 $- Launch Year Based on slides presented by Tom Ransohoff, BioProcess Technology Consultants. 17

18 Past & Current Processes Past and current processes From large scale stainless steel to single-use and / or continuous processing or hybrid De-risking Higher flexibility Faster turn-around Closed systems Advanced PAT Smaller footprint Best of both worlds Flexibility Meeting broad range of demand Hybrid facilities 18

19 Hybrid facility - 2 parallel engines Production section - engine technology Single use section Stainless steel section Target for facility section Reducing investment cost Flexibility Reducing operation costs Increasing capacity Typical use Clinical and Launch Changing production schedule Commercial supply Stable production scenarios 19

20 Hybrid SUS Seed Train in SS Facility Faster Changeover using SUB s reducing no of seed train bioreactors Single use systems 20

21 Open Mind Regarding Technology Choice TRADITIONAL STAINLESS STEEL GUY THE PRAGMATIC GUY SINGLE USE TECHNOLOGY GUY 21

22 ROBOTICS 22

23 TECHNOLOGY INNOVATION AND EVOLUTION Robotics Mitigate cross contamination risk Mitigate human errors Sustainable commercial manufacturing (cost) 23

24 Compounding of potent drugs Future drugs are becoming more toxic and potent and batch sizes are getting smaller. This increase the need for keeping the operator away from the product Robot density 2015 (all industries) China has a robot density of just 36 but they aim for a density of 150 by 2020 An increase of 600,000 industrial robots by 2020 Robot sales was globally 254,000 in 2015 Robots/10,000 employees Source IFR: World robotics

25 Collaborative robots Cobots are the new black! Cobots Can work in close proximity with people no fence Force limited Built-in force torque sensors that detect impact and abnormal forces, which stops the robot when overloaded Ideas for use: Part assembly or pack of medicinal kits Small batch sizes 25

26 Mobile Autonomous Robots Autonomous Self-driving and navigating No wiring needed Uses sonar and laser for detection (SLAM*) Ideas for use: Ideal for material transport *SLAM: Simultaneous Localisation and Mapping 26

27 MODULAR APPROACH 27

28 Modular different definitions Modular Copy / Paste On-site construction, where same type of rooms are build as copies same size and configuration Modular off site construction of building elements LEGO concept A method of construction that utilizes off-site pre-engineered, pre-fabricated structures which are reassembled on-site. Up to 100% of the building and the equipment are already completed and pre-tested at the factory prior to shipping Modular - PODular Full clean-room facilities built in a POD, including HVAC, air locks etc., which is build and qualified off-site. The POD s are then shipped to the site for the pharmaceutical production and connected to the stick built part of the facility 28

29 Modular thinking Air Handling 29

30 Modular thinking

31 Layout 3D Air Handlin g

32 Modular thinking Façade - Adapted to local rules and building traditions Technical support modules HVAC etc. Technical distribution modules. 1 Process area Process and Support building modules. Foundations for building modules and Technical distribution (water, drains, waste etc.) 32

33 CONCLUSION 33

34 Future Possibilities Multi product flexible facilities Prepared for future expansions and new products Hybrid facilities Motorway and city roads Optimal use of SUS, Continuous Processing and other new technologies Lower area classification few airlocks larger suits Modular facility designs Yes the robots are coming Flexibility standardisation simplification 34

35 Morten Munk Global Technology Partner Thank you NNE A/S Mobile: