bioreactor 4.0 qbd- and pat- platform for the biopharmaceutical
TRANSCRIPT
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
Company IntroductionBilfinger Industrietechnik Salzburg GmbH
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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
Products and Solutions
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Consulting for Bio-Processes Bio-Process Equipment After-Sales Services
Bilfinger Bio-Process Equipment Combining our skills for your success
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Aux. BioprocessEquipment:
e.g. CIP/SIP unit,Media/bufferprep. & storage
FermentationSystems,
Lab-Bioreactors(Modular or fullycostumized)
▪ 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
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Your bioprocess on our focus
Bioreaktor 4.0Transition to QbD
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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
Bioreaktor 4.0PAT & QbD
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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
Bioreaktor 4.0Customer objectives TODAY related to PAT/QbD
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� 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
Bioreaktor 4.0From Labscale to Production Scale
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Pilot-ScaleLab-Scale Production Scale
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/