technology and innovation are driving change in the...

Unrestricted © Siemens AG 2017

23. Juni 2017 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



MindSphere + Video

Digitalization changes everything



“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



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



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.



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



Technology and Innovation is driving change in the Pharma Industry…



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



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


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



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


design

Process &

plant design

1 2

Producing, filling and packaging a product requires specific technologies and processes



Production

engineering

Production

execution


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



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


design

Process &

plant design

1 2


11. May 2017 Page 15 Pharma Forum 2017 – Bart Moors, Siemens


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


design

Process &

plant design

1 2




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


design

Process &

plant design

1 2

Virtual

Commission-

ing




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


design

Process &

plant design

1 2




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


design

Process &

plant design

1 2




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


design

Process &

plant design

1 2



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



Integrated Operations through Paperless Manufacturing

Integrating Manual and Automated Operations



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/>.



The digital twin

b-u-s_maschine.mp4



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

https://www.siemens.com/global/en/home/company/topic-areas/ingenuity-for-life/biontech.html






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



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:

[email protected]

Thank you for your attention!

siemens.com/pharma

mailto:[email protected]

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