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
Process Control
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
Automation
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
Extensive Characterization
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
Process Insight
SIMCA®
Powerful multivariate data analysis tool with interactive visualizations, an intuitive interface, and automatable workflows for comprehensive process understanding
