Sartorius PSC Manufacturing Solution
Scalable, GMP-compliant, automated solution to enable robust manufacturing of iPSC derivatives
- Control strategy: Use multivariate software package to develop and implement control strategies and trajectory correction procedures with advanced sensitive PAT-enabled single-use bioreactor and single-use low-shear centrifuge as well as consistent serum-free, xeno-free medium, sterile connection-disconnection, and a 3-hour PCR-based sterility test
- Automation: Reduce setup, execution, and handling times with data-driven automated expansion and differentiation processes as well as automated harvest, downstream processing, buffer and media formulation, and aliquoting
- Remote manufacturing: Enable full-process management through integration with native Emerson DeltaV® controls and predictive, multivariate modeling and control
- Assured supply: Maintain high iPSC derivative product quality through high- and consistent-quality low-E&L consumables manufactured under complete control of single-use supply chain backed by long-term business continuity
Control Strategy
SIMCA®-online
Multivariate prediction technology for actionable insights into manufacturing trajectory correction to achieve consistent PSC cell quality
Biostat STR® Generation 3
Single-use bioreactor system with Biobrain® automation platform to help deliver consistent PSC therapies at commercial scale
Biobrain®
Automation platform with analytical suite for process control and data capture, storage, and visualization to enable predictability and scalability
Flexsafe STR®
Single-use, low-E&L bags with non-invasive sensors for pH, DO, viable biomass monitoring and online glucose and lactate measurements
NutriStem® hPSC XF
Defined, serum-free, xeno-free PSC expansion medium to support expansion of undifferentiated hPSCs. FDA DMF on file
kSep® Centrifugation System
Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream PSC processing
Microsart® ATMP
3-hour PCR-based kit enables fast and reliable detection of mycoplasma, bacteria, and fungi for in-process testing during an PSC manufacturing run
Biowelder® TC
Fully automated welder for sterile connection of dry or liquid-filled thermoplastic tubing to enable sterile, closed-system processing of PSC therapy products
Biosealer® TC
Fully automated sterile disconnection device to produce permanent and consistent leak-free seals and enable sterile, closed-system processing of PSC therapy products
Flexsafe® 2D
Single-use, low-E&L bags of superior strength and flexibility that meet the highest business continuity requirements and serve media and buffer storage and mixing needs
Mycap®
One-piece, single-use bottle closure for sterile filling, storage, and transfer of fluids to enable a safe, closed-system PSC seed train
Palletank® for Storage
Perfect fit and protection of Flexsafe® 3D Bags for safe and robust storage of fluids
Automation
Biobrain®
Automation platform with analytical suite for process control and data capture, storage, and visualization to enable predictability and scalability
Biostat STR® Generation 3
Single-use bioreactor system with Biobrain® automation platform to help deliver consistent PSC therapies at commercial scale
kSep® Centrifugation System
Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream PSC processing
Flexsafe® Pro Mixer
Fast, flexible, and intelligent single-use mixer for all mixing steps in cGMP bioprocessing to maximize throughput
Biowelder® TC
Fully automated welder for sterile connection of dry or liquid-filled thermoplastic tubing to enable sterile, closed-system processing of PSC therapy products
Biosealer® TC
Fully automated sterile disconnection device to produce permanent and consistent leak-free seals and enable sterile, closed-system processing of PSC therapy products
Remote Manufacturing
Biostat STR® Generation 3
Single-use bioreactor system with Biobrain® automation platform to help deliver consistent PSC therapies at commercial scale
Biobrain®
Automation platform with analytical suite for process control and data capture, storage, and visualization to enable predictability and scalability
SIMCA®-online
Multivariate prediction technology for actionable insights into manufacturing trajectory correction to achieve consistent PSC cell quality
Assured Supply
Flexsafe STR®
Single-use, low-E&L bags with non-invasive sensors for pH, DO, viable biomass monitoring and online glucose and lactate measurements
Flexsafe® 2D
Single-use, low-E&L bags of superior strength and flexibility that meet the highest business continuity requirements and serve media and buffer storage and mixing needs
Flexsafe® Pro Mixer Bag
Single-use, rapid-installation bag for media or buffers in Palletank® for Mixing to expedite the mixing run and facilitate bag handling during the mixing process
Flexsafe® 3D
Single-use, resin-optimized bag for storage of media and buffer designed to work with Palletank® for Storage with complete control and traceability of raw materials and manufacturing process
