Sartorius PSC Manufacturing Solution

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
Contact an iPSC Therapy Consultant

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

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

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

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 PSC Manufacturing Solution Data Sheet Collection

PDF | 16.0 MB

Complete The Form Below To Request To Be Contacted By an iPSC Therapy Consultant