Bosch Packaging Technology - achema.de€¦ · A broad portfolio for a wide smile. Exciting...

Bosch Packaging Technology

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.

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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


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. 3

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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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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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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Isolator/Containment: Bosch Solution Active/ Passive Closed RABS Liquid

Isolator Liquid

Containment Solid

Supported by extensive services


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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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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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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



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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



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A broad portfolio for a wide smile. Exciting solutions from a single source.

Bosch Packaging Technology - achema.de€¦ · A broad portfolio for a wide smile. Exciting...

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