Bosch Packaging Technology

Transcription

1 Bosch Packaging Technology

2 Technologies that excite 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. 2

3 Megatrends Easier access to medication, increasing number of lifestyle diseases, higher demand for individualized medicines Rising awareness of dietary habits and health implications, higher demand for quality health care and original medicines Increasing life expectancy, number of older people, higher demand for medication Rising income, growing middle class Higher education standards Growing importance of efficient resource usage, decrease waste and spoilage also in pharma Demographic change Sustainability Changing lifestyles, access to medicines Urbanization Globalization is picking up speed and the world population is growing by 80 million people every year. Digitization New therapy management for chronic diseases, more data on adherence I 4.0 solutions 3

4 Continuous Manufacturing Trends Impact for pharmaceutical industry 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 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 4

5 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 5

6 Isolator/Containment Trends Growth of fill/finish line numbers due to rising healthcare 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 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 6

7 Isolator/Containment: Bosch Solution Active/ Passive Closed RABS Liquid Isolator Liquid Containment Solid Supported by extensive services 7

8 Industry 4.0 Trends 100% pharmaceutical quality Drug shortage and changing market demands Price pressure, especially for generics Stricter regulatory environment for batch records, signatures and validation 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 8

9 Industry 4.0 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 Smart machines Bosch Pharma MES and Track & Trace Data Services 9 Consultation and implementation of projects

10 Supplier vs. Partnership Trends Impact 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) 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 10

11 : Bosch as a partner R&D Planning and Engineering Commissioning / Ramp-up Phase Operating Phase Formulation development Support in investment projects Qualification service packages Support during operations Regulatory support Consulting Data Analytics Services to plan and execute investments Process and equipment experts Smoke studies under dynamic conditions according to GMP Support of process and machine experts during ramp-up Training After sales services, re-qualification Process-consulting, improvement Bosch as a partner across the life-cycle of new products 11

12 Bosch Packaging Technology USPs Extensive experience in the pharmaceutical industry to meet all customer requirements Extensive services to support development, scale-up, qualification/validation, and project fulfillment, ensuring uptime and output The right technology to support production processes Your reliable partner: support throughout your project, meeting quality requirements and deadlines for your fast time-to-market Worldwide service network with local footprint for fast support Industry 4.0 connected, data-based solutions from one source 12

13 Technologies that excite See A broad portfolio for a wide smile. Exciting solutions from a single source. 13