Digitalization in Pharma Howard Sachs, Business Segment Pharmaceuticals, Siemens. Unrestricted Siemens AG 2017

Transcription

1 Digitalization in Pharma Howard Sachs, Business Segment Pharmaceuticals, Siemens Realize innovation. Page 1

2 changes everything MindSphere + Video Digitalization 2016 Page 2

3 Digitalization Changes Everything, Everywhere The pace of technological advances is fueling digital transformation The cost of key technologies is falling Implications of Moore s Law DRONES $100,000 $700 COST PER UNIT 200 Cost of technology Transistor density D 2007 $40, PRINTING INDUSTRIAL ROBOTS $100 $550,000 $20, SENSORS SMART $30,000 $80 $ $ PER 1 MILLION TRANSISTORS 1000 TRANSISTOR COUNT PHONES Source: Accenture Technology Vision $10 Source: Leading Technology Research Vendor Page 3

4 The Digital (r)evolution Siemens has been at the forefront since the beginning of the Industrial Revolution 1 st Industrial Revolution 2 nd Industrial Revolution 3 rd Industrial Revolution 4 th Industrial (r)evolution Digitalization Water & Steam Electrification Automation Digitalization is still being defined Page 4

5 Pharmaceutical plant Plant of the of future the Future flexibility, faster market readiness and improved productivity Increasing flexibility, faster market readiness and improved productivity Page 5

6 Technology is driving change in the Pharma Industry Page 6

7 New Technologies are driving innovative manufacturing solutions Technological trends are driving transformation Technology Trends Business Transformation Continuous Manufacturing Paperless manufacturing Additive Manufacturing & 3D Printing Technological Distinctiveness In-plant transformation Big Data & Analytics Simulation Robotics Network Sophistication Labor modernisation Page 7

8 Solutions for R&D and Recipe Transformation Early stage Late stage / Industrialization Discovery Lead Preselection Pre- Clinical Phase I Phase IIa (Proof of Concept) Phase IIb Phase III Filing Launch Manufacturing Drug Discovery Lab & Animal testing Number of Volunteers Tens Hundreds Thousands Formulation Product Design Process/Product & Plant Development Engineering & Bulk API Operation Commissioning Secondary Manufacturing Services Time to market Quality / Regulations Flexibility Efficiency Page 8

9 Bridge the GAP from Laboratory to to the Patient GLP Quality Target Product Profiles General Recipe GCP Data Analysis (PAT), Quality and Deviation Management Recipe Transformation CQA CPA CPP CCP Site Recipe S95 GMP Batch S88 Conti S106 Patient Process Page 9

10 A holistic approach in the Pharma Industry Specific for process and discrete part of the digital enterprise Producing, filling and packaging a product requires specific technologies and processes Process value Product chain 1 2 Process & plant 1 Product 2 Processand plant Services engineering execution 3 Engineering 4 Operation 5 Services Discrete value chain 1 Product 2 planning engineering execution Services Page 10

11 Digitalization in the Pharma industry Product Design 1 Product 2 Process & plant engineering execution Services Formula Design Package Design Product and formula Artwork development Regulatory compliance Package Quality testing Quality by Design Simulation & digital prototyping Label and compliance Page 11

12 Digitalization in the Pharma Industry Process Understanding 1 Product 2 Process & plant engineering execution Services Modelling the process Continuous Process Verification Recipe Creation of the bill of process Trial/ validation Collaborative line Modelling the production facility Capacity simulation of the plant Controlling critical process parameters Real time release Page 12

13 Digitalization in the Pharma industry Engineering 1 Product 2 Process & plant engineering execution Services Automation of the process Automation of the production line Plant Machine & selection Electrical Mechatronics integration Automation engineering Automation engineering Virtual Commissioning Virtual Commissioning Page 13

14 Digitalization in the Pharma Industry 1 Product 2 Process & plant engineering execution Services Process Automation CQA / CPP/ MPC Collect Q-Data IN-Line/On-line CQA measurement Determine CQA/CPP Control CPP Golden Batch Transfer analytical data Advanced Process Control Real Time Release Testing Page 14

15 Digitalization in the Pharma industry Execution 1 Product 2 Process & plant engineering execution Services Integrated MES / Batch / Automation Flexible Paperless Manufacturing Order download & scheduling Reporting & Dashboards Advanced Planning & Scheduling Electronic Batch record Integrated MES/DCS Quality Management Quality Execution Real Time Release Page 15

16 Digitalization in the Pharma industry Services 1 Product 2 Process & plant engineering execution Services Smart Condition Monitoring Manufacturing Intelligence Energy Analytics Smart Condition Monitoring Manufacturing Intelligence Smart Condition Monitoring Cyber Security Cyber Security CPAS CPAS Page 16

17 Digitalization in the Pharma industry Services 1 Product 2 Process & plant engineering execution Services Calibration and Smart Condition Monitoring Manufacturing Intelligence Energy Analytics Manufacturing Intelligence Smart Condition Monitoring Smart Condition Monitoring Cyber Security Cyber Security CPAS CPAS Page 17

18 Summary The Vision Comes to Life Key Advantages of Digitalization Use Simulation to achieve foresight in the Virtual World Use Big Data Analytics to gain insight and drive continuous improvement 1 Product 2 Process & plant engineering execution Services Page 18 Drive intra-company and supplier collaboration via data integration

19 Integrated Operations through Paperless Manufacturing Integrating Manual and Automated Operations Page 19

20 Integrated Operations through Paperless Manufacturing Integrating Manual and Automated Operations Integrated Recipe Integrated Workflow Standardized S88 model for Automated and Manual Operations Integrated HMI Your benefits from going paperless Integrated Deviations Integrated Appendices Save time in engineering and thanks to the native integration between the control system and MES Improve guidance and control for both manual and automated operations Drastically reduce review and approval efforts thanks to Review by Exception Page 20

21 Continuous Manufacturing First FDA approved change 1 from traditional batch to continuous Raw Material 1 Raw Material 2 Raw Material 3 Raw Material 4 Feeders Innovative partnerships to transform manufacturing operations NIR Blender Transforming assembled unit operations to continuous PAT Enabled central control system NIR Tablet Press Reject Continuous quality verification Real time release testing Smaller footprint and reduced waste Coating solution End product Improved yield and labor cost savings Coating pan FDA: Food Drug Administration NIR: Near Infrared PAT: Process Analytical Technology Yu, Lawrence, Ph.D. "Continuous Manufacturing Has a Strong Impact on Drug Quality." FDA Voice. 12 Apr < Page 21

22 Intelligent Immersive Manufacturing Proof of Concept for the Pharmaceutical Factory of the Future Demonstrating the art of the possible Consider current and future operator requirements Provide an innovative and immersive operator experience Use real automation and equipment for a real industrial context Seek, incubate and deploy advanced technology Optimize operations and visibility Page 22

23 The digital twin Page 23

24 The digital twin for pharmaceuticals the Bausch & Ströbel example Bausch + Ströbel Maschine SFM 5110 B+S Maschine (M2 Portfolio) from the pharma industry contains all important element from the Siemens Packaging Mechatronic Concept and Vitrual Commissioning er Key Reference for Digitalisation SIMATIC S7-1517TF HMI IFP 1900 INOX is fully enclosed SINAMICS S210 Midrange Drive Integrated Engineering Integrated Concept d. - NX, MCD Mechanical d. - NX, CAD Software d. Electrical d. Commissioning - TIA-Portal/Scout - SIZER /Project Generator (virtual) Operating (Mindsphere) Page 24

25 Personalized Medicine Creating a digital plant for personalized vaccines Advanced paperless manufacturing Central access point for data Enable fast scale up Eliminate paper-based batch reports and Review by exception Intelligent guidance, planning and scheduling Link to BioNTech video on Page 25

26 New Technologies are driving Innovative Manufacturing Solutions Real examples of technological transformation and innovation Integrated Engineering Paperless (ebr) Continuous (PAT) Flexible Bio- PLM for Vaccine Manufacturing of the Future Integrated Secondary Lines Personalized Medicine Page 26

27 Thank you for your attention! Howard Sachs Business Segment Pharma Siemens LTD Melbourne, Australia Page 27