Sartorius AG · XETR:SRT
Sartorius — Technical Presentation (2021)
40 slides from Sartorius's technical presentation, 2021
Slide 1: Putting the “D” in CDMO with Data Analytics and Ambr
Putting the “D” in CDMO with Data Analytics and Ambr® Tiffany McLeod Kevin McHugh
Slide 2: Agenda
Agenda Market Trends & Analysis CDMOs Pursuing QbD Technologies that Can Accelerate Process Development at CDMOs — Ambr® Systems Overview Why Ambr® and Data Analytics? 2
Slide 3: Biopharmaceutical CDMOs: Distribution of Biologics by Operations
Biopharmaceutical CDMOs: Distribution of Biologics by Operations INTER-SCALE DISTRIBUTIONS • Lab and Clinical operations make up a 30 30 30 26 majority of the CDMO 31 31 31 32 34 operations 42 • 57% of lab scale, 56% of 41 45 43 41 40 39 40 40 clinical scale operations have been occupied by vaccines
Slide 4: Bioprocess Development Technology Trends
Bioprocess Development Technology Trends In-Silico Experimentation This disruptive technology influencing all industries including Pharma and Biotech and the hype is real. In-silico-based tools are part of drug targeting, screening and discovery, clinical studies and predictive analytics related to
Slide 5: Bioprocess Development Technology Trends
Bioprocess Development Technology Trends In-Silico Experimentation High-throughput Process Continuous Bioprocessing Development ... Soft Sensor Digital Twin 5
Slide 6: Agenda
Agenda Market Trends & Analysis CDMOs Pursuing QbD Technologies that Can Accelerate Process Development at CDMOs — Ambr® Systems Overview Why Ambr® and Data Analytics? 6
Slide 7: Why Regulatory Agencies are Pushing Quality by Design (QbD)
Why Regulatory Agencies are Pushing Quality by Design (QbD) Perform Mathematic Process Process Continuous Identify Optimization Characterization Process Risk al Modeling Objectives Improvement Assessment (i.e. DOE) Determine CPPs Factors Ongoing Set QTPPs Design Space Control Strategy Monitoring and
Slide 8: Why Should CDMOs Have Strong QbD Packages?
Why Should CDMOs Have Strong QbD Packages? Attractor for Potential Reduce Risks Partners and Delays Ensure Well Developed Overcoming Scalable Resource Processes Demonstrate Crunches Expertise (time, COGs) 8
Slide 9: How Can CDMOs Develop Strong QbD Packages?
How Can CDMOs Develop Strong QbD Packages? Commitment to Innovation Develop and Clear Continuous Lend Strategies Improvement Experience and Leverage from other Procedures Wealth of Projects and for Managing Focused Knowledge Programs Projects Expertise in and Analytics and Experience Process Develop
Slide 10: Agenda
Agenda Market Trends & Analysis CDMOs Pursuing QbD Technologies that Can Accelerate Process Development at CDMOs — Ambr® Systems Overview Why Ambr® and Data Analytics? 10
Slide 11: Fully Scalable Range of Single-Use Bioreactors from 15 mL to 2000 L
Fully Scalable Range of Single-Use Bioreactors from 15 mL to 2000 L Following Conventional Stirred Tank Design Principles
Slide 12: Ambr 15 Cell Culture
Ambr® 15 Cell Culture More representative Predictive Clone selection Transient transfection studies Media and feed screening Mammalian and insect cell lines Early process optimization Suspension cell lines and adherent cell lines on microcarriers (e.g 293, Vero) Batch, fed-batch and pe
Slide 13: Ambr 15 Generation 2 Workstation Features and Functionality
Ambr® 15 Generation 2 Workstation Features and Functionality New Liquid Handler New Flexible deck improves precision layout allows more process flexibility New Culture Station design improves temp. control and increases stirrer speed range New Large tip bin 24 or 48 vessels Active cooling option New
Slide 14: BioPAT Clone Selection
BioPAT ® Clone Selection Enabling Simple Consistent Clone/Strain Selection Currently the selection of the top clones or strains is performed upon visual inspection of specific quality parameters or one number readout (e.g. max titre or IVCC) The selection process is user dependent and the full power
Slide 15: Ambr 250 High Throughput: the Fast Track to Intensified Cell Culture Process Development
Ambr® 250 High Throughput: the Fast Track to Intensified Cell Culture Process Development This next-generation bioreactor system can enable and enhance your perfusion process development in these key areas: Reduce complexity and setup time with single-use perfusion bioreactors Increase experimen
Slide 16: Ambr 250 High Throughput Workstations
Ambr® 250 High Throughput Workstations 12 Vessel 24 Vessel Perfusion Option Automated system for Class II Analysis Module aseptic bolus addition equivalent and sampling 13 feet BSC Bed locations for pipette Chilled sample storage 12 or 24 tips and stirred bed Perfusion pump with an option for freeze
Slide 17: Ambr 250 High Throughput Vessels
Ambr® 250 High Throughput Vessels Micro Carrier 30mm Rushton Single-Use Vessel Vessel Microbial Vessel Access Liquid cap manifold Condenser DO sensor Foam Thermowell sensor Biomass Sensor port pH Sparge Electrode tube Baffles Rushton impeller
Slide 18: Ambr 250 High Throughput Perfusion Option– Key Features
Ambr® 250 High Throughput Perfusion Option– Key Features Fits into the existing footprint of a standard ambr®250 high throughput system Fully capable of operating in either fed-batch or perfusion modes ATF & TFF consumable includes a single-use perfusion filter and single-use pump chambers I
Slide 19: Ambr 250 Modular System
Ambr® 250 Modular System Single-Use Vessel Workstation Variable speed ‘x pump’ allows for flexible use and quick reactor harvesting. Simple and efficient pH and gassing, and agitation connections Integrated off-gas analyzers available for CO2, and O2 Measurement, as well as OUR, CER, and RQ calculat
Slide 20: Easily Develop Advanced Control Strategies
Easily Develop Advanced Control Strategies Flexible Control Strategies: Setpoints can be based on a value, equation, profile, or even OPC input. Not just for pumps but also process parameters Easy to use Triggers Variety of options available to easily automate the transition between phases
Slide 21: High Throughput Upstream Process Characterization Platform Development—Cost and Time Saving
High Throughput Upstream Process Characterization Platform Development— Cost and Time Saving Comparison With Traditional Approach Ambr® 250 – 24 Vessel Configuration 0 20 40 60 80 100 120 140 160 180 200 $120,000.00 $100,000.00 $80,000.00 $60,000.00 $40,000.00 $20,000.00 Training $0.00 0 20 40 60
Slide 22: Scalable, Automated At-Line and Real Time Process Monitoring and Control
Scalable, Automated At-Line and Real Time Process Monitoring and Control From 15 mL to 2000 L SU bioreactors PAT facilitates the implementation of QbD! NOVA Flex II ViCell XR with ESM BioPAT® Foam BioPAT® BioPAT ® Trace X-gas Off-gas and Foam Sensors Online Analysis Biomass EC/SU pH Module w/ BioPAT
Slide 23: Spectroscopy Platform across Scales enabling straight-forward Model-Transfer
Spectroscopy Platform across Scales enabling straight-forward Model- Transfer Rowland‐Jones, RC, Graf, A, Woodhams, A, et al. Spectroscopy integration to miniature bioreactors and large scale production bioreactors– Increasing current capabilities and model transfer. Biotechnol Progress. 2020;e3074.
Slide 24: Agenda
Agenda Market Trends & Analysis CDMOs Pursuing QbD Technologies that Can Accelerate Process Development at CDMOs — Ambr® Systems Overview Why Ambr® and Data Analytics? 24
Slide 25: Ambr and Data Analytics: The Perfect Match
Ambr® and Data Analytics: The Perfect Match How can I maximize my Ambr ® data? 25
Slide 26: From Data to Decisions
From Data to Decisions Sartorius Data Analytics tools examine large amounts of data to uncover hidden patterns. MODDE® SIMCA® 26
Slide 27: Design, Execute and Analyze Experiments Quickly and Easily
Design, Execute and Analyze Experiments Quickly and Easily MODDE® Design of Experiments Familiar interface for defining factors and responses. Functionality to automatically import setpoints and extract responses from ambr15 experiments Not only end point but min, max, timepoints, etc. Sof
Slide 28: DOE vs MVDA for Ambr Experiments
DOE vs MVDA for Ambr® Experiments MODDE® DOE SIMCA® MVDA Media Component Screening Cell Line and Clone Screening Bioreactor Condition Optimization Bioreactor Condition Optimization vs Feed Strategy Optimization Feed Strategy Optimization Spectroscopy Calibration Modeling Bioreactor Characterization
Slide 29: Ambr DOE Examples
Ambr® DOE Examples Media Component Screening Bioreactor Optimization and Characterization Challenge: Not all commercially available media supports every cell line, therefore in some cases Challenge: additional supplements must be added to improve cell performance A significant challenge for deve
Slide 30: Ambr MVDA Examples
Ambr® MVDA Examples Spectroscopy Calibration Modeling Feed-Strategy Optimization Challenge PAT tools can (i.e. spectral devices, advanced sensors and analyzers) generate large Challenge amounts of complex data presenting a challenge when it comes to interpreting accuracy A significant challenge
Slide 31: Combining the Best of Both Worlds for Ambr Scale-down Modeling
Combining the Best of Both Worlds for Ambr® Scale-down Modeling Combine multi-objective optimization criteria (DOE) with quantitative ranking (MVDA) Squeeze all the value from the data you have 31
Slide 32: DOE and MVDA for Ambr Scale-down Modeling
DOE and MVDA for Ambr® Scale-down Modeling MVDA Used to Evaluate Major Sources of Variability Between Ambr ® and 5L Reference Scale DOE Establishment of Scale-down Bioprocess Models for Ambr Using Clustered Multivariate Analysis, Timo Schmidberger, Thomas Krieg, Sartorius (2020) 32
Slide 33: DOE and MVDA for Ambr Scale-down Modeling
DOE and MVDA for Ambr® Scale-down Modeling The goal in scale-down modeling is to decrease the distance between the scaled-down runs and the target scale To do this we can use MODDE® DOE to evaluate the length and give suggestions as to how to change operating parameters to reduce scale differenc
Slide 34: DOE and MVDA for Ambr Scale-down Modeling
DOE and MVDA for Ambr® Scale-down Modeling DOE Establishment of Scale-down Bioprocess Models for Ambr Using Clustered Multivariate Analysis, Timo Schmidberger, Thomas Krieg, Sartorius (2020) 34
Slide 35: DOE and MVDA for Ambr Scale-down Modeling Method Conformation
DOE and MVDA for Ambr® Scale-down Modeling Method Conformation DOE Establishment of Scale-down Bioprocess Models for Ambr Using Clustered Multivariate Analysis, Timo Schmidberger, Thomas Krieg, Sartorius (2020) 35
Slide 36: DOE and QbD are Key for CDMO Success
Putting the “D” in CDMO with Advanced Process Development, American Pharmaceutical Review, Greg Flyte (2016) DOE and QbD are Key for CDMO Success “The most successful CDMOs, therefore, have identified strategies for completing process development projects efficiently and effectively while incorporat
Slide 37: Visit the CDMO Landing page
Visit the CDMO Landing page www.landing.umetrics.com/en/cdmo Read the latest blogs and Try the ROI calculator Book a strategy session watch the recorded webinars 37
Slide 38: Visit Sartorius at IFPAC 2021
Visit Sartorius at IFPAC 2021 38
Slide 39: How CDMOs can Digitalize their Cell and Gene Therapy Processes
How CDMOs can Digitalize their Cell and Gene Therapy Processes Join our next webinar in the CDMO Webinar Series March 24th 4-5 PM CET | 10-11 AM EST More Info Can Be Found on the CDMO landing page www.landing.umetrics.com/en/cdmo 39
Slide 40: Thank you!
Thank you! Tiffany McLeod Kevin McHugh 40