Sartorius MSC Pilot Solution
Scaled-up, automated, high-throughput solution to develop process insight through CPP and CQA correlation to establish a safe, robust MSC manufacturing process
- Process control: Scaled-up optimal expansion process in controlled cell culture (pH, DO, temperature, stirring speed) with consistent, serum-free, xeno-free MSC medium, low-shear harvesting and 3-hour sterility checkpoints in 0.6 – 2 L volumes
- Automation: Minimize manual processes using an automated benchtop bioreactor and continuous-flow centrifuge system coupled with walkaway automation flow cytometry and live cell analysis platforms
- Extensive characterization: Monitor MSC morphology and growth using live-cell analysis and acquire paracrine effect understanding with advanced flow cytometry analysis
- Process insight: Gain clear actionable results using powerful multivariate data analysis software for real-time MSC process monitoring and quality characterization analytics to correlate CPPs and CQAs
Univessel®
Automated, scalable benchtop bioreactor system for closed-system 3D MSC expansion (0.6 to 2 L)
MSC NutriStem® XF Basal Media
Defined, serum-free, xeno-free MSC expansion medium to maintain normal morphology, stable karyotype, and trilineage differentiation potential
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
SoloHill® Microcarriers
Sterile, ready-to-use microcarriers in a variety of formats that support rapid and efficient attachment and growth of MSCs in suspension culture
kSep® Systems
Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream MSC processing at pilot scale
MSCgo™ Differentiation Media
Serum-free, xeno-free MSC trilineage differentiation potential testing (osteogenic, adipogenic, and chondrogenic)
Microsart® ATMP Mycoplasma
3-hour PCR-based kit enables fast and reliable detection of mycoplasma, bacteria, and fungi for in-process testing of MSC-based therapeutics
Mycap®
One-piece, single-use bottle closure for sterile filling, storage, and transfer of fluids to enable a safe, closed-system MSC production process
Univessel®
Automated, scalable benchtop bioreactor system for closed-system 3D MSC 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 MSC processing at pilot scale
iQue® 3
Advanced high-throughput flow cytometry platform for MSC phenotypic analysis and immunomodulation and cytokine profiling assessment
Incucyte® SX5
Automated, real-time, live-cell analysis platform for quantitative insights into MSC health, morphology, proliferation, and function
Incucyte® SX5
Automated, real-time, live-cell analysis platform for quantitative insights into MSC health, morphology, proliferation, and function
iQue® 3
Advanced high-throughput flow cytometry platform for MSC phenotypic analysis and immunomodulation and cytokine profiling assessment
SIMCA®
Powerful multivariate data analysis tool with interactive visualizations, an intuitive interface, and automatable workflows for comprehensive process understanding
