Technology and Innovation are driving change in the pharmaceutical industry Stefan Krauß Business Segment Pharmaceuticals, Siemens AG

Size: px

Start display at page:

Download "Technology and Innovation are driving change in the pharmaceutical industry Stefan Krauß Business Segment Pharmaceuticals, Siemens AG"

Samuel McDaniel
6 years ago
Views:

1 Technology and Innovation are driving change in the pharmaceutical industry Stefan Krauß Business Segment Pharmaceuticals, Siemens AG Realize innovation. Page 1

2 MindSphere + Video Digitalization changes everything Page 2

3 We now generate as much data every 640 K should be enough 48 for hours everybody as from the start Bill of Gates, humanity 1981 to 2003 Source: Edward Bryan IBM Page 3

4 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 4

5 Industrie 4.0 Readiness Index RB Industry 4.0 Readiness Index Page 5 Potentialists Norway UK Denmark France Manufacturing share Netherlands Belgium Sweden Finland Spain Estonia Italy Portugal Hesitators Latvia Switzerland Frontrunners Austria Poland Croatia Traditionalists Germany Ireland Czech Rep. Hungary Lithuania Slovenia Slovak Rep. The RB Industry 4.0 Readiness Index is represented on the vertical axis, calculated as follows: production process sophistication, degree of automation, workforce readiness and innovation intensity have been bundled into a category = "industrial excellence". High value added, industry openness, innovation network and Internet sophistication have been combined into a category labeled "value network". The combination of these two categories determines a country's position in the RB 4.0 Readiness Index. The horizontal axis represents the traditional industry measure the manufacturing share. Source: Roland Berger

Recipe, feedstock quality, Process & plant documentation Real Plant Smart Sensors Secure Connectivity Integrated Operations &

6 Siemens drives the Digital Enterprise for Process Industries VIRTUAL WORLD Big Data Integrated Engineering Cloud platform and operating system (2D/3D) & commissioning Digital Twin & Simulation Data analytics Asset Performance Management REAL WORLD Recipe, feedstock quality, Process & plant documentation Real Plant Smart Sensors Secure Connectivity Integrated Operations & Services Digitally enhanced products Maintenance Process & Engineering & 1 Product 2 Operation plant 3 commissioning 4 5 Service Page 6

7 Technology and Innovation is driving change in the Pharma Industry Page 7

are driving transformation Technology Trends

Manufacturing Paperless manufacturing Additive

Distinctiveness In-plant transformation Big

8 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 modernization Page 8

testing Number of Volunteers Tens Hundreds Thousands Formulation Product Design Process/Product & Plant Development

9 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 9

10 Integrating and digitalizing the entire value chain is key to staying competitive in the future Page 11

value Product chain 1 2 Process & plant 1 Product 2 Processand plant 3 4 5 Services engineering execution 3

11 Our 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 12

Product and formula Artwork development Regulatory compliance Package Quality

12 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 13

Digitalization in the Pharma Industry Process Understanding 1 Product 2 Process & plant 3 4 5

Creation of the bill of process Trial/ validation Collaborative line Modelling the production

13 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 14

Digitalization in the Pharma Industry Process and Plant Design 1 Product 2 Process & plant 3 4 5 engineering execution Services Modelling the production facility Planning the line Creation of general

14 Digitalization in the Pharma Industry Process and Plant Design 1 Product 2 Process & plant engineering execution Services Modelling the production facility Planning the line Creation of general recipe Creation of the bill of process Trial/ validation Collaborative line Modelling the production facility Capacity simulation of the plant Simulation of critical process steps Simulation and bottleneck elimination Page May 2017 Pharma Forum 2017 Bart Moors, Siemens

Digitalization in the Pharma industry Engineering 1 Product 2 Process & plant 3 4 5

production line Plant Machine & selection Electrical Mechatronics integration

15 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 16

Digitalization in the Pharma Industry 1 Product 2 Process & plant 3 4 5

Q-Data IN-Line/On-line CQA measurement Determine CQA/CPP Control CPP Golden

16 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 17

Digitalization in the Pharma industry Execution 1 Product 2 Process & plant 3 4 5

Manufacturing Order download & scheduling Reporting & Dashboards Advanced Planning &

17 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 18

18 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 19

19 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 22

20 Integrated Operations through Paperless Manufacturing Integrating Manual and Automated Operations Page 23

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

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

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 24

22 The digital twin Page 26

Personalized Medicine Creating a digital plant for personalized vaccines Advanced paperless manufacturing Central access point for data Enable fast scale up

23 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 release by exception Intelligent guidance, planning and scheduling Link to BioNTech video on Page 27

Step by step towards the digital plant Future-proof products and solutions for the pharmaceutical industry Using Integrated software solutions, Simulation and collaborative platforms Fast, reliable

24 Step by step towards the digital plant Future-proof products and solutions for the pharmaceutical industry Using Integrated software solutions, Simulation and collaborative platforms Fast, reliable communication networks Data security Smart services to analyze data generated Pharma-specific process expertise and innovative drives and automation technology For A shorter time-to-market Better quality and security More flexibility and efficiency Page 28

25 Thank you for your attention! Stefan Krauß Technical Director Pharma PD PA AE PHA 3 Siemensallee Karlsruhe Phone: +49 (721) Cellular: +49 (173) stefan.krauss@siemens.com siemens.com/pharma Page 29

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

Digitalization in Pharma Howard Sachs, Business Segment Pharmaceuticals, Siemens Realize innovation. Page 1 changes everything MindSphere + Video Digitalization 2016 Page 2 Digitalization Changes Everything,