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Unrestricted © Siemens AG 2017
23. Juni 2017 Page 1 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Technology and Innovation are
driving change in the
pharmaceutical industry Stefan Krauß
Business Segment Pharmaceuticals, Siemens AG
Realize innovation. Unrestricted © Siemens AG 2017
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 2 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
MindSphere + Video
Digitalization changes everything
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 3 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
“640 K should be enough for everybody …
Bill Gates, 1981
We now generate as much
data every
48 hours as from the start
of humanity to 2003
Source: Edward Bryan IBM
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 4 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Digitalization Changes Everything, Everywhere
The pace of technological advances is fueling digital transformation
DRONES
3D
PRINTING
INDUSTRIAL
ROBOTS
SENSORS
SMART
PHONES
COST PER UNIT
2014
2014
$40,000
$100
2007
2014
2007
2007
2007
2014
2007
2014
The cost of key technologies is falling
Cost of technology 200
100
10
1
0
$ PER 1 MILLION TRANSISTORS
Source: Accenture Technology Vision 2015
Transistor density
’92 ’93 ’94 ’95 ’96 ’97 ’98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08 ’09 ’10 ’11 ’12 ‘13 ’14 ’15 ’16
Source: Leading Technology Research Vendor
$100,000
$700
$550,000
$20,000
$30,000
$80
$449
$10
100000
10000
1000
100
10
1000000
1000 TRANSISTOR COUNT
Implications of Moore’s Law
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 5 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Industrie 4.0 Readiness Index
Source: Roland Berger
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.
1 2 3 4 5
1
2
3
4
5
RB Industry 4.0
Readiness Index
Manufacturing
share
Potentialists Frontrunners
Traditionalists
Hesitators
Norway
UK
Denmark
France
Netherlands
Belgium
Switzerland
Germany
Ireland
Sweden
Finland
Austria
Spain Estonia Italy
Portugal
Latvia
Poland Croatia
Czech Rep.
Hungary
Lithuania Slovenia
Slovak Rep.
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 6 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Siemens drives the Digital Enterprise for Process Industries
Digital Twin & Simulation
Recipe,
feedstock
quality, …
Process &
plant
documen-
tation
Real Plant
Integrated Operations
& Services
Digitally enhanced products
Secure Connectivity
Maintenance
Cloud platform and operating system
Asset Performance Management
Integrated Engineering
(2D/3D) & commissioning
Data analytics
Product design Process &
plant design
Engineering &
commissioning Operation Service 1 2 3 4 5
VIRTUAL
WORLD
REAL
WORLD
Smart Sensors
Big Data
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 7 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Technology and Innovation is driving change in the Pharma Industry…
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 8 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
New Technologies are driving innovative manufacturing solutions
Technological trends are driving transformation
Technology Trends
Simulation Robotics
Continuous Manufacturing
Paperless manufacturing
Additive Manufacturing & 3D Printing
Big Data & Analytics
Business Transformation
Technological
Distinctiveness
In-plant
transformation
Network
Sophistication Labor modernization
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 9 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Solutions for R&D and Recipe Transformation
Discovery
Lead
Pre-selection
Pre-Clinical
Phase I
Phase IIa
(Proof of Concept)
Phase IIb
Phase III Filing Launch Manufacturing
Early stage
Late stage / Industrialization
Drug Discovery
Lab & Animal testing
Number of Volunteers
Tens Hundreds Thousands
Formulation Design
Process/Product Development
Bulk API Production
Secondary Manufacturing
Time to
market
Flexibility
Quality /
Regulations
Efficiency
Engineering &
Commissioning Operation Services
Product
design
Process & Plant
design
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 11 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Integrating and digitalizing the entire value chain is key to staying
competitive in the future
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 12 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Our holistic approach in the Pharma Industry
Specific for process and discrete part of the digital enterprise
Process value chain
Engineering Operation Services 3 4 5 Product
design
Process-
and plant
design
1 2
Discrete value chain
Production
engineering
Production
execution
Services 3 4 5 Product
design
Production
planning 1 2
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Producing, filling and packaging a product requires specific technologies and processes
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 13 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Digitalization in the Pharma industry
Product Design
Formula Design
Product and
formula design
Regulatory
compliance
Quality testing
Quality by
Design
Package Design
Artwork
development
Package
design
Simulation &
digital
prototyping
Label design
and
compliance
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 14 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Digitalization in the Pharma Industry
Process Understanding
Recipe
Trial/ validation
Modelling the
production
facility
Capacity
simulation of
the plant
Creation of the
bill of process
Collaborative
line design
Controlling
critical process
parameters
Real time
release
Modelling the
process
Continuous
Process Verification
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Unrestricted © Siemens AG 2017
11. May 2017 Page 15 Pharma Forum 2017 – Bart Moors, Siemens
Digitalization in the Pharma Industry
Process and Plant Design
Creation of
general recipe
Trial/ validation
Modelling the
production
facility
Capacity
simulation of
the plant
Creation of the
bill of process
Collaborative
line design
Simulation of
critical process
steps
Simulation and
bottleneck
elimination
Modelling the
production facility
Planning the
Production line
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 16 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Digitalization in the Pharma industry
Production Engineering
Automation design
of the process
Automation design
of the production line
Plant design
Electrical
design
Automation
engineering
Machine
design &
selection
Mechatronics
integration
Automation
engineering
Virtual
Commission-
ing
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Virtual
Commission-
ing
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 17 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Digitalization in the Pharma Industry
Production
Process Automation
Collect Q-Data
Determine
CQA/CPP
Golden Batch
Transfer
analytical data
CQA / CPP/ MPC
IN-Line/On-line
CQA
measurement
Control CPP
Advanced
Process
Control
Real Time
Release
Testing
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 18 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Digitalization in the Pharma industry
Production Execution
Flexible Paperless Manufacturing Integrated MES / Batch / Automation
Advanced
Planning &
Scheduling
Electronic
Batch record
Quality
Management
Real Time
Release
Order
download &
scheduling
Reporting &
Dashboards
Integrated
MES/DCS
Quality
Execution
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 19 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Digitalization in the Pharma industry
Services
Manufacturing Intelligence Smart Condition Monitoring
Manufacturing
Intelligence
Smart
Condition
Monitoring
Cyber Security
CPAS
Energy
Analytics
Smart
Condition
Monitoring
Cyber Security
CPAS
Production
engineering
Production
execution
Services 3 4 5 Product
design
Process &
plant design
1 2
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 22 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
New Technologies are driving Innovative Manufacturing Solutions
Real examples of technological transformation and innovation
Integrated Engineering Paperless (eBR)
PLM for Vaccine Production Manufacturing of the Future Integrated Secondary Lines Personalized Medicine
Continuous (PAT) Flexible Bio-Production
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 23 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Integrated Operations through Paperless Manufacturing
Integrating Manual and Automated Operations
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 24 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
NIR
Continuous Manufacturing
First FDA approved change1 from traditional batch to continuous
Blender
Reject
Coating
solution
End product
Raw Material 1
Raw Material 2
Raw Material 3
Raw Material 4
Tablet Press
Coating pan
Feeders Innovative partnerships to transform
manufacturing operations
• Transforming assembled unit operations to continuous
• PAT Enabled central control system
Continuous quality verification
Real time release testing
Smaller footprint and reduced waste
Improved yield and labor cost savings
NIR
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. 2016.
<https://blogs.fda.gov/fdavoice/index.php/2016/04/continuous-manufacturing-has-a-strong-impact-on-drug-quality/>.
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 26 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
The digital twin
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 27 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
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 www.siemens.com
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 28 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
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
Unrestricted © Siemens AG 2017
23. Juni 2017 Page 29 Lunch & Learn, Frankfurt – Stefan Krauß, Siemens
Stefan Krauß
Technical Director Pharma
PD PA AE PHA 3
Siemensallee 84
76187 Karlsruhe
Phone: +49 (721) 595-85808
Cellular: +49 (173) 6542605
E-Mail:
Thank you for your attention!
siemens.com/pharma