Digitalization in Pharma - GMP Consultants, pharmaceutical

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



MindSphere + Video

Digitalizationchanges

everything




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



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



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



Technology 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

SophisticationLabor modernisation



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



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



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


design

Process &

plant design1 2

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



Production

engineering

Production

execution


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



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 design1 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 design1 2

Virtual

Commission-

ing



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


design

Process &

plant design1 2




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


design

Process &

plant design1 2




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


design

Process &

plant design1 2




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


design

Process &

plant design1 2



Production

engineering

Production

execution


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



Integrated Operations through Paperless Manufacturing

Integrating Manual and Automated Operations



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



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/>.



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



The digital twin



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



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

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



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



Thank you for your attention!

Howard Sachs

Business Segment Pharma

Siemens LTD

Melbourne, Australia

[email protected]

+61 407 826 294

mailto:[email protected]

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Digitalization in Pharma - GMP Consultants, pharmaceutical