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Transcript of Bioreactor 4.0 QbD- and PAT- Platform for the Biopharmaceutical ...
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Bioreactor 4.0QbD- and PAT- Platform for the Biopharmaceutical ProductionPablo Pino Grace
Bilfinger Industrietechnik Salzburg GmbH
ACHEMA 2015, Frankfurt am Main | 15 -19 June 2015
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Company IntroductionBilfinger Industrietechnik Salzburg GmbH
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 2
Business units � Pipelines and assembly � Plants and systems� Water solutions
Established 1955 (since 2009 part of Bilfinger Group)
Sales 2014 € 73 million
Staff 260
Headquarters Salzburg
Locations Vienna, KundlHeidelberg, Penzberg, StuttgartZurich
Regional operations
China, ShanghaiSouth Korea, SeoulEastern Europe
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Products and Solutions
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 3
Consulting for Bio-Processes Bio-Process Equipment After-Sales Services
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Bilfinger Bio-Process Equipment Combining our skills for your success
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 4
Aux. BioprocessEquipment:
e.g. CIP/SIP unit,Media/bufferprep. & storage
FermentationSystems,
Lab-Bioreactors(Modular or fullycostumized)
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▪ Design of Bioreactor System close to your Bioprocess
Bilfinger PRO QUBE
▪ Modular Hardware & Automationfor easy configuration
▪ Suitable accessories
▪ Intelligent Plant Management
▪ Add-ons for successful cultivation
▪ PAT & QbD solution for operational excellence
Bioreaktor 4.0
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 5
Your bioprocess on our focus
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Bioreaktor 4.0Transition to QbD
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 6
CURRENT STATE
Process
End producttesting
OOS or Rejectunacceptable
products
Variableinput
Fixedprocess
Variableoutput
QUALITY BY INSPECTION
DESIRED FUTURE STATE
ProcessVariable
input
Robust andAdjustable
Process
Variableoutput
QUALITY BY DESIGN
Real time monitoringand control
Facilitated e.g.by PAT / DS
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Bioreaktor 4.0PAT & QbD
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 7
Hol
d /
rele
ase
LabProcess data
(Temp, Pressure, Oxygen,…)Closed loopcontrol LIMS
Sample
Classic control
Process Analyzer
monitoringanalyzer data
monitoringproduct quality
QbD
mathematicaltranslation
Real-timerelease
Advanced Control
Quality build in by designRight first time
Process feed
Process output
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Bioreaktor 4.0Customer objectives TODAY related to PAT/QbD
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 8
� Increase in Productivity (€)
� Shorten Time to Market (€€).
� Consistent end-product quality (€€)
� Real Time Release (€€)
� Decrease Regulatory burden (€)
Increase process understanding/ manage variability
Central interface for all PAT tools
Find relations between all relevant data (in-line, at-line, on-line and off-line)
Shift from lab testing towards in RealtimeRelease testing
Enable advanced process control based on PAT data
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Bioreaktor 4.0From Labscale to Production Scale
Bioreactor 4.0 | Bilfinger Industrietechnik Salzburg page 9
Pilot-ScaleLab-Scale Production Scale
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Thank you very much for your attention!Bilfinger Industrietechnik Salzburg GmbH
Bergerbräuhofstraße 315020 Salzburg / Austria
Phone: +43 662 8695-0E-mail: [email protected]
www.it-salzburg.bilfinger.com/en/