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
Contact an MSC Therapy Consultant

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

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

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

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

Sartorius MSC Manufacturing Solution Data Sheet Collection

PDF | 18.2 MB

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