Sartorius MSC Manufacturing Solution
Scalable, automated, closed system solution to enable robust, high-quality manufacturing of MSC-based therapies
- Control strategy: Using multivariate software package to develop and implement control strategies and trajectory correction procedures with advanced sensitive PAT-enabled single-use bioreactor and low-shear centrifuge as well as consistent serum-free, xeno-free medium, sterile connection-disconnection, and 3-hour PCR-based sterility testing
- Automation: Reduce setup, execution, and handling times with data-driven automated MSC upstream and downstream processing systems and online monitoring control
- Remote manufacturing: Enable full-process management through integration with native Emerson DeltaV® controls and predictive, multivariate data analysis tools
- Assured supply: Maintain consistent production of MSC-based therapies using high-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 MSC cell quality
Biostat STR® Generation 3
Single-use bioreactor system with Biobrain® automation platform to help deliver consistent MSC 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
MSC NutriStem® XF Basal Media
Defined, serum-free, xeno-free MSC expansion medium to maintain normal morphology, stable karyotype, and trilineage differentiation potential. Manufactured under cGMP. FDA Drug Master File
SoloHill® Microcarriers
Sterile, ready-to-use microcarriers in a variety of formats and package configurations for rapid, efficient attachment and expansion of MSCs in suspension culture
kSep® Centrifugation System
Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream MSC processing
Microsart® ATMP Mycoplasma
3-hour PCR-based kit enables fast and reliable detection of mycoplasma, bacteria, and fungi for in-process testing during an MSC manufacturing run
Biowelder® TC
Fully automated welder for sterile connection of dry or liquid-filled thermoplastic tubing to enable sterile, closed-system processing of MSC therapy products
Biosealer® TC
Fully automated sterile disconnection device to produce permanent and consistent leak-free seals and enable sterile, closed-system processing of MSC 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 MSC 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 MSC 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 MSC 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 MSC therapy products
Biosealer® TC
Fully automated sterile disconnection device to produce permanent and consistent leak-free seals and enable sterile, closed-system processing of MSC therapy products
At-Scale Throughput
Biostat STR® Generation 3
Single-use bioreactor system with Biobrain® automation platform to help deliver consistent MSC 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 MSC 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
