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Data analytics and software sensors for
single use bioprocessing
Dr. Patrick Sagmeister
Exputec GmbH
Get There Faster.28 September 2018 | Exputec - Get There Faster | 2
Exputec at a glance
 “Exputec offers comprehensive solutions for
biopharmaceutical and industrial biotechnology
companies to improve and run better development and
production processes.”
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 3
Data Analytics Goals
•Acceleration of
R&D stages
•Well-
characterized,
high-performing
bioprocesses
•BLA information
completeness
•Robust &
validated
production
•Reduction of
failed batches
•Quick resolution
of mfg issues
•Rapid scale-up of
processes
•Consistent
documentation
and qualification
•Qualified scale
models
•Complete &
consistent data
sets, full data
integrity
•Correct statistical
workflows
•Validation Report
completeness
Bioprocess
R&D
Scale-up &
Tech Transfer
Process
Validation
Manufacturing
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 4
Collaborative Data Analytics
Manufacturing
Quality
External Labs
Large
Biotech
Orginator
Small
Biotech
Orginator
Other Sites
R&D
Get There Faster.Sagmeister P, Wechselberger P, Herwig C. PDA J Pharm Sci Technol, 66(6), 526-541 (2012).
Interactions of process
parameters and cell
physiology
Interactions of up- and
downstream unit operations
 We need sensors environment of the cell, metabolites, impurities, identity
 We need data analytics to ensure quality
Product & Impurtities
)_(
)_(
)(_
stateCellfPurityCQAs
stateCellfCQAsIdentity
PPsfstateCell



Product Quality in Bioprocesses
Software Sensors
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 7
What is a Software Sensor?
The Measurement, Monitoring, Modelling and Control
(M3C), a working group of ESBES, explains the origin of
the name softsensors:
“The term combines the words “because the sensor signal
evaluation software”, models are usually implemented in
computer programs, and “sensors”, because these models
are delivering information similar to hardware sensors”
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 8
8
Software Sensors Types
1. First principle soft sensors
calculation of volumetric
rates, specific rates and
yield coefficients
estimation of unknown
non-measured variables
2. Differential equation
models/ hybrid models
For cell culture processes,
ODE modelling preferred
model type
3. Data driven software
sensors
INPUT OUTPUT
Accumulation
and Conversion
States
(concentrations)
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 9
9
Softsensor – What can I monitor?
Substrates
Galactose
Glucose
Glutamine
Glycerol
Pyrovate
Sychrose
Metabolites
Acetate
Ammonia
Formate
Lactate
Products
Acetate
Ammonia
Formate
Lactate
Biomass
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 10
10
Case Study of Software Sensors in GMP
 VCD, lactate, glutamate
 CHO process
 Implemented in GMP
environment, production
scale
EXPUTEC AND SIEMENS:
ACTIVATING THE DESIGN SPACE
FOR CGMP MANUFACTURING,
BIOINNOVATION LEADERS SUMMIT,
BERLIN, 2017
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 11
How to Validate a Software Sensor?
 Audit trails for models, access protection etc. to meet FDA
21 CFR Part 11 and EudraLex Annex 11 requirements.
equipment
historian
LIMs
BR / ELN
PQ for data interfaces and
models individually executed
resulting in fully validated
system
IQ / OQ /PQ for core
software available and
performed by 3rd party
Validation
Partners
Data Analytics
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 13
What is data analytics?
“Analytics is the discovery, interpretation, and
communication of meaningful patterns in data”
“Process Validation is defined as the
collection and evaluation of data, from the
process design stage throughout
production, which establishes scientific
evidence that a process is capable
of consistently delivering quality
product FDA process validation guideline”
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 14
Data Analytics - Challenges
 Data mining
 How to get data from collaborators?
 Compliance
 Data integrity
 Compliant data analytics
 Lots of data – little time
 Multivariate data analytics for every
scientist and engineer
How to deal with Outliers in Data Analytics ?
 Outliers can crush your data analytics and lead to
wrong results
 Two Options
 1) Remove them;
 2) Use robust multivariate statistics
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 16
Robust Multivariate Data Analytics
Paradigm shift: Multivariate statistics not for experts but for
every scientist and engineer
Get There Faster.
28 September 2018 | Exputec - Get There Faster | 17
Take Home Messages
 Software sensor or
softsensor
Complement existing sensors
Decrease IPC samples
Validated
Custom made
 Data analytics
Collaborative!
Duty of Engineers &
Scientists
Thank you! Dr. Patrick Sagmeister, EXPUTEC GmbH
Mariahilferstraße 147/2/2D | A-1150 Wien |
T: +43 1 9972849 | M: +43 680 400 500 7
E-mail: patrick.sagmeister@exputec.com |
www.exputec.com

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Data analytics and software sensors for single use bioprocessing

  • 1. Data analytics and software sensors for single use bioprocessing Dr. Patrick Sagmeister Exputec GmbH
  • 2. Get There Faster.28 September 2018 | Exputec - Get There Faster | 2 Exputec at a glance  “Exputec offers comprehensive solutions for biopharmaceutical and industrial biotechnology companies to improve and run better development and production processes.”
  • 3. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 3 Data Analytics Goals •Acceleration of R&D stages •Well- characterized, high-performing bioprocesses •BLA information completeness •Robust & validated production •Reduction of failed batches •Quick resolution of mfg issues •Rapid scale-up of processes •Consistent documentation and qualification •Qualified scale models •Complete & consistent data sets, full data integrity •Correct statistical workflows •Validation Report completeness Bioprocess R&D Scale-up & Tech Transfer Process Validation Manufacturing
  • 4. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 4 Collaborative Data Analytics Manufacturing Quality External Labs Large Biotech Orginator Small Biotech Orginator Other Sites R&D
  • 5. Get There Faster.Sagmeister P, Wechselberger P, Herwig C. PDA J Pharm Sci Technol, 66(6), 526-541 (2012). Interactions of process parameters and cell physiology Interactions of up- and downstream unit operations  We need sensors environment of the cell, metabolites, impurities, identity  We need data analytics to ensure quality Product & Impurtities )_( )_( )(_ stateCellfPurityCQAs stateCellfCQAsIdentity PPsfstateCell    Product Quality in Bioprocesses
  • 7. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 7 What is a Software Sensor? The Measurement, Monitoring, Modelling and Control (M3C), a working group of ESBES, explains the origin of the name softsensors: “The term combines the words “because the sensor signal evaluation software”, models are usually implemented in computer programs, and “sensors”, because these models are delivering information similar to hardware sensors”
  • 8. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 8 8 Software Sensors Types 1. First principle soft sensors calculation of volumetric rates, specific rates and yield coefficients estimation of unknown non-measured variables 2. Differential equation models/ hybrid models For cell culture processes, ODE modelling preferred model type 3. Data driven software sensors INPUT OUTPUT Accumulation and Conversion States (concentrations)
  • 9. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 9 9 Softsensor – What can I monitor? Substrates Galactose Glucose Glutamine Glycerol Pyrovate Sychrose Metabolites Acetate Ammonia Formate Lactate Products Acetate Ammonia Formate Lactate Biomass
  • 10. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 10 10 Case Study of Software Sensors in GMP  VCD, lactate, glutamate  CHO process  Implemented in GMP environment, production scale EXPUTEC AND SIEMENS: ACTIVATING THE DESIGN SPACE FOR CGMP MANUFACTURING, BIOINNOVATION LEADERS SUMMIT, BERLIN, 2017
  • 11. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 11 How to Validate a Software Sensor?  Audit trails for models, access protection etc. to meet FDA 21 CFR Part 11 and EudraLex Annex 11 requirements. equipment historian LIMs BR / ELN PQ for data interfaces and models individually executed resulting in fully validated system IQ / OQ /PQ for core software available and performed by 3rd party Validation Partners
  • 13. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 13 What is data analytics? “Analytics is the discovery, interpretation, and communication of meaningful patterns in data” “Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality product FDA process validation guideline”
  • 14. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 14 Data Analytics - Challenges  Data mining  How to get data from collaborators?  Compliance  Data integrity  Compliant data analytics  Lots of data – little time  Multivariate data analytics for every scientist and engineer
  • 15. How to deal with Outliers in Data Analytics ?  Outliers can crush your data analytics and lead to wrong results  Two Options  1) Remove them;  2) Use robust multivariate statistics
  • 16. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 16 Robust Multivariate Data Analytics Paradigm shift: Multivariate statistics not for experts but for every scientist and engineer
  • 17. Get There Faster. 28 September 2018 | Exputec - Get There Faster | 17 Take Home Messages  Software sensor or softsensor Complement existing sensors Decrease IPC samples Validated Custom made  Data analytics Collaborative! Duty of Engineers & Scientists
  • 18. Thank you! Dr. Patrick Sagmeister, EXPUTEC GmbH Mariahilferstraße 147/2/2D | A-1150 Wien | T: +43 1 9972849 | M: +43 680 400 500 7 E-mail: patrick.sagmeister@exputec.com | www.exputec.com

Editor's Notes

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  2. Money lost in iterative characterization / validation cycles / lost batches ? Huge optimization potential „these guys know what my problem is“ should be the reaction References on losses to the above For detailed pitch deck, case studies (win doesn‘t have to be in money, but can also be time or batches) Only mention the value chain and move on to what we do specifically Options for quick wins / pricing ? Pilots? Project based? Enteprise projects? verbal On-premise and SaaS
  3. Single point of truth for data and workflows – Share Data with External Partners Selectively share data with internal and external collaborators
  4. Biopharmaceuticals are defined as “A protein or nucleic acid based pharmaceutical substance used for therapeutic or in vivo diagnostic purposes, which is produced by means other than direct extraction from a native (non-engineered) biological source” [5].
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