Sartorius PSC Pilot Solution

Scaled-up, semi-automated solution to develop a robust iPSC manufacturing protocol

  • Process control: Scale up optimal expansion and differentiation process in controlled cell cultures of iPSCs and derivatives (pH, DO, temperature, stirring speed) with consistent, serum-free, xeno-free iPSC expansion medium, low-shear harvesting and 3-hour sterility checkpoints in 0.6-2L volumes
  • Automation: Minimize manual time using integrated DCU for real-time monitoring of cell growth and differentiation and continuous-flow centrifuge as well as walkaway automation advanced flow cytometry and continuous live-cell analysis platforms
  • Extensive characterization: Acquire differentiation marker information using advanced flow cytometry and detect morphological changes during differentiation using continuous live-cell analysis
  • Process insight: Optimize your scale-up strategy with in-depth process understanding obtained through the correlation of CPPs and CQAs using process and characterization data
Contact an iPSC Therapy Consultant

Univessel®

Automated, scalable benchtop bioreactor system for closed-system 3D PSC expansion (0.6 to 2 L)

NutriStem® hPSC XF

Defined, serum-free, xeno-free PSC expansion medium to support expansion of undifferentiated hPSCs. FDA DMF on file

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

kSep® Systems

Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream PSC processing at pilot scale

Microsart® ATMP

3-hour PCR-based kit enables fast and reliable detection of mycoplasma, bacteria, and fungi for in-process testing of PSC-based therapeutics

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

Univessel®

Automated, scalable benchtop bioreactor system for closed-system 3D PSC expansion (0.6 to 2 L)

kSep® Systems

Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream PSC processing at pilot scale

iQue® 3

Advanced high-throughput flow cytometry platform for phenotypic analysis of PSC and PSC derivatives and differentiation tracking

Incucyte® SX5

Automated, real-time, live-cell imaging and analysis platform for quantitative insights into PSC and PSC derivative health, morphology, proliferation and function

Incucyte® SX5

Automated, real-time, live-cell imaging and analysis platform for quantitative insights into PSC and PSC derivative health, morphology, proliferation and function

iQue® 3

Advanced high-throughput flow cytometry platform for phenotypic analysis of PSC and PSC derivatives and differentiation tracking

SIMCA®

Powerful multivariate data analysis tool with interactive visualizations, an intuitive interface, and automatable workflows for comprehensive process understanding

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