Achema 2018

1. Bosch Packaging Technology

2. Technologies that excite
What influences pharmaceutical industry today and tomorrow?
PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
2
A broad portfolio for
a wide smile.
Exciting solutions
from a single source.
As a full-service-provider of
processing and packaging
technologies we are always
at your side – throughout the
entire machine life cycle.

3. Higher
education
standards
Demographic
change
What influences pharmaceutical industry today and tomorrow?
Rising income,
growing middle
class
Urbanization
PA-MBS, PA-PH/MBC | March 2018
Digitization
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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Megatrends
Growing importance of
efficient resource usage,
decrease waste and spoilage
also in pharma
Rising awareness of dietary habits and
health implications, higher demand for
quality health care and original medicines
New therapy
management for
chronic diseases,
more data on
adherence
I 4.0 solutions
Increasing life expectancy,
number of older people,
higher demand for
medication
Easier access to medication, increasing
number of lifestyle diseases, higher
demand for individualized medicines
Changing lifestyles,
access to medicines
Globalization is picking
up speed and the world
population is growing by
80 million people every year.
Sustainability

4. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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What influences pharmaceutical industry today and tomorrow?
Trends and Developments
Trends
 Increasing share of stratified medicines
 High market share and profitability for first
supplier of innovative drugs
 Price pressure for generics
 Higher requirements on pharmaceutical quality
 Regulatory support for continuous
manufacturing
Continuous Manufacturing
Impact for pharmaceutical industry
 Smaller batch sizes
 Faster time-to-market, avoid risks and reduce
time for scale-up
 Reduce costs, less waste of API in start-up and
at the end of production
 Build-up of experience in handling continuous
manufacturing processes, meet quality targets

5. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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What influences pharmaceutical industry today and tomorrow?
Trends and Developments
Continuous Manufacturing
Bosch Xelum solution
 Discrete mass dosing for precise dosing of smallest amounts
 System doses and mixes individual packages, so-called X-keys
 Proven fluid-bed technology, no scale-up necessary
 Services from Bosch to support customers

6. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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What influences pharmaceutical industry today and tomorrow?
Trends and Developments
Isolator/Containment
Impact for pharmaceutical industry
 Additional capacity for fill/finish lines, also in
emerging markets with isolator technology
 New smaller batch filling equipment combined
with isolator
 Build-up of competences and SOPs for processes
in sites without isolator/containment technology
 Higher health, safety and environment
requirements, also in OSD
 Defining internal standard isolator/containment
solutions
Trends
 Growth of fill/finish line numbers due to rising health-
care access in emerging countries as well as new
medicines for targeted therapies (small batch lines)
 Highly potent products: basic cytostatic medicines or
Antibody-Drug-Conjugates (ADC’s)
 Regulatory push by FDA/EMA with indirect
recommendations for isolators in guidelines
 Acceptance of isolator in industry

7. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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What influences pharmaceutical industry today and tomorrow?
Trends and Developments
Isolator/Containment: Bosch Solution
Active/ Passive Closed RABS
Liquid
Isolator
Liquid
Containment
Solid
Supported by extensive services

8. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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What influences pharmaceutical industry today and tomorrow?
Trends and Developments
Trends
 100% pharmaceutical quality
 Drug shortage and changing market demands
 Price pressure, especially for generics
 Stricter regulatory environment for batch records,
signatures and validation
Industry 4.0
Impact
 Higher understanding for root-causes, faster reaction
time to deviations
 Production of necessary quantity in complex supply
chain
 Cost pressure
 Compliance to regulatory and quality requirements
more complex and time consuming

9. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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What influences pharmaceutical industry today and tomorrow?
Trends and Developments
Industry 4.0
Smart machines Bosch Pharma MES and Track & Trace Data Services
Consultation and implementation of projects
Transparency is the basis to be able to take knowledge-based decisions
 Obtain transparent machine- and process data: correct, available and acquired by secure means (data integrity)
 Today: enable trouble shooting and optimization (analysis for root cause, algorithms), reactive measures
 Outlook: predictive solutions, pro-active measures

10. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
10
What influences pharmaceutical industry today and tomorrow?
Trends and Developments
Trends
 Rising challenges for the pharmaceutical industry
 Shorter time to markets
 Price pressure for generics
 Changing demand from the market
 Higher process and machine complexity
 Rising quality and process understanding
requirements by changing regulations
(e.g. Annex1)
Supplier vs. Partnership
Impact
 Increased complexity for staff
 Increased tasks, new drug types (e.g. ADCs)
 Several new technologies and processes
 Build-up of competences across multiple sites
worldwide
 High time pressure
 Limited number of staff to cope with increased
workload

11. PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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What influences pharmaceutical industry today and tomorrow?
Trends and Developments: Bosch as a partner
 Formulation development
 Regulatory support
 Consulting
 Data Analytics
Bosch as a partner across the life-cycle of new products
 Support in investment projects
 Services to plan and execute
investments
 Process and equipment experts
 Support during operations
 Training
 After sales services,
re-qualification
 Process-consulting, improvement
 Qualification service packages
 Smoke studies under dynamic
conditions according to GMP
 Support of process and machine
experts during ramp-up
R&D Operating PhaseCommissioning / Ramp-up PhasePlanning and Engineering

12. Worldwide service network with local footprint for fast support
Your reliable partner: support throughout your project, meeting quality requirements
and deadlines for your fast time-to-market
What influences pharmaceutical industry today and tomorrow?
PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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Bosch Packaging Technology USPs
The right technology to support production processes
Extensive services to support development, scale-up, qualification/validation, and project fulfillment,
ensuring uptime and output
Extensive experience in the pharmaceutical industry to meet all customer requirements
Industry 4.0 – connected, data-based solutions from one source

13. Technologies that excite
 See
What influences pharmaceutical industry today and tomorrow?
PA-MBS, PA-PH/MBC | March 2018
© Robert Bosch Packaging Technology GmbH 2018. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
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A broad portfolio for
a wide smile.
Exciting solutions
from a single source.