Unrestricted © Siemens AG 2017
24 July 2017Page 1 Business Segment Pharma, Howard Sachs
Digitalization in PharmaHoward Sachs, Business Segment Pharmaceuticals, Siemens
Realize innovation.Unrestricted © Siemens AG 2017
Unrestricted © Siemens AG 2017
24 July 2017Page 2 Business Segment Pharma, Howard Sachs
MindSphere + Video
Digitalizationchanges
everything
Unrestricted © Siemens AG 2016
Unrestricted © Siemens AG 2017
24 July 2017Page 3 Business Segment Pharma, Howard Sachs
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 technology200
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
24 July 2017Page 4 Business Segment Pharma, Howard Sachs
The Digital (r)Evolution
Siemens has been at the forefront since the beginning of the Industrial
Revolution
Water & SteamElectrification
Automation
Digitalization
Digitalization
is still being
defined…
4th Industrial
(r)Evolution3rd Industrial
Revolution2nd Industrial
Revolution1st Industrial
Revolution
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24 July 2017Page 5 Business Segment Pharma, Howard Sachs
Pharmaceutical plant of the future
Increasing flexibility, faster market readiness and improved productivityPharmaceutical Plant of the Future
Increasing flexibility, faster market readiness and improved productivity
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24 July 2017Page 6 Business Segment Pharma, Howard Sachs
Technology is driving change in the Pharma Industry…
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24 July 2017Page 7 Business Segment Pharma, Howard Sachs
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
SophisticationLabor modernisation
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24 July 2017Page 8 Business Segment Pharma, Howard Sachs
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 stageLate stage / Industrialization
Drug Discovery
Lab & Animal testing
Number of Volunteers
Tens Hundreds Thousands
Formulation Design Process/Product Development Bulk API ProductionSecondary Manufacturing
Time to
market
Flexibility
Quality /
Regulations
Efficiency
Engineering &
CommissioningOperation Services
Product
design
Process & Plant
design
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24 July 2017Page 9 Business Segment Pharma, Howard Sachs
Bridge the GAP from Laboratory to Production … to the Patient
S95
Process
Pati
en
t
Data Analysis (PAT), Quality and Deviation Management
GLP GMPGCP
Batch
S88
Conti
S106
Recipe Transformation
CQA
CPA
CPP
CCP
Quality Target Product Profiles
General RecipeSite Recipe
Unrestricted © Siemens AG 2017
24 July 2017Page 10 Business Segment Pharma, Howard Sachs
A holistic approach in the Pharma Industry
Specific for process and discrete part of the digital enterprise
Process value chain
Engineering Operation Services3 4 5Product
design
Process-
and plant
design
1 2
Discrete value chain
Production
engineering
Production
execution
Services3 4 5Product
design
Production
planning1 2
Production
engineering
Production
execution
Services3 4 5Product
design
Process &
plant design1 2
Producing, filling and packaging a product requires specific technologies and processes
Unrestricted © Siemens AG 2017
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Production
engineering
Production
execution
Services3 4 5Product
design
Process &
plant design1 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
24 July 2017Page 12 Business Segment Pharma, Howard Sachs
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
Services3 4 5Product
design
Process &
plant design1 2
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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
Services3 4 5Product
design
Process &
plant design1 2
Virtual
Commission-
ing
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24 July 2017Page 14 Business Segment Pharma, Howard Sachs
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
Services3 4 5Product
design
Process &
plant design1 2
Unrestricted © Siemens AG 2017
24 July 2017Page 15 Business Segment Pharma, Howard Sachs
Digitalization in the Pharma industry
Production Execution
Flexible Paperless ManufacturingIntegrated 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
Services3 4 5Product
design
Process &
plant design1 2
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Digitalization in the Pharma industry
Services
Manufacturing IntelligenceSmart Condition Monitoring
Manufacturing
Intelligence
Smart
Condition
Monitoring
Cyber Security
CPAS
Energy
Analytics
Smart
Condition
Monitoring
Cyber Security
CPAS
Production
engineering
Production
execution
Services3 4 5Product
design
Process &
plant design1 2
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Digitalization in the Pharma industry
Services
Manufacturing
Intelligence
Calibration and
Smart Condition Monitoring
Manufacturing
Intelligence
Smart
Condition
Monitoring
Cyber Security
CPAS
Energy
Analytics
Smart
Condition
Monitoring
Cyber Security
CPAS
Production
engineering
Production
execution
Services3 4 5Product
design
Process &
plant design1 2
Unrestricted © Siemens AG 2017
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Production
engineering
Production
execution
Services3 4 5Product
design
Process &
plant design1 2
Summary – The Vision Comes to Life
Key Advantages of Digitalization
Drive intra-company and supplier collaboration via data
integration
Use Big Data Analytics to gain insight and drive
continuous improvement
Use Simulation to
achieve foresight in the Virtual
World
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24 July 2017Page 19 Business Segment Pharma, Howard Sachs
Integrated Operations through Paperless Manufacturing
Integrating Manual and Automated Operations
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Your benefits from going paperless
✓ Save time in engineering and design 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”
Integrated Operations through Paperless Manufacturing
Integrating Manual and Automated Operations
Standardized
S88 model for
Automated
and Manual
Operations
Integrated
Recipe
Integrated
Workflow
Integrated
Deviations
Integrated
Appendices
Integrated
HMI
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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/>.
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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
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The digital twin
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24 July 2017Page 24 Business Segment Pharma, Howard Sachs
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 designer
• Key Reference for Digitalisation
• SIMATIC S7-1517TF
• HMI IFP 1900 INOX is fully enclosed
• SINAMICS S210 Midrange Drive
Concept d.
- NX, MCD
Mechanical d.
- NX, CAD
Electrical d.
- SIZER
Software d.- TIA-Portal/Scout
/Project Generator
Commissioning
(virtual)
Operating
(Mindsphere)
Integrated Engineering
Inte
gra
ted
Pro
du
cti
on
Unrestricted © Siemens AG 2017
24 July 2017Page 25 Business Segment Pharma, Howard Sachs
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 www.siemens.com
Unrestricted © Siemens AG 2017
24 July 2017Page 26 Business Segment Pharma, Howard Sachs
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
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Thank you for your attention!
Howard Sachs
Business Segment Pharma
Siemens LTD
Melbourne, Australia
+61 407 826 294
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