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Technologies that excite
What influences pharmaceutical industry today and tomorrow?
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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.
Higher education standards
Demographic change
What influences pharmaceutical industry today and tomorrow?
Rising income, growing middle class
Urbanization
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Digitization
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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
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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
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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
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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
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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
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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
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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
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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
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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 Phase
Commissioning / Ramp-up Phase
Planning and Engineering
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?
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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
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.