GMP - GMP Unit at SCI-TReCS

Upstream Technology

• establishment of scalable technologies for the production of EVs (bioreactor technologies) under GMP conditions
• validation of immortalized cell lines as a stable starting resource for quality assurance of production
• manufacture of master and working cell banks to ensure consistent output cells

Downstream Technology

• establishment and validation of a GMP compliant production train via tangential flow filtration (TFF) and size exclusion chromatography (SEC)
• development of nanoparticle tracking analysis (NTA / FL-NTA) analysis systems for quality control and product release
• establishment and validation of analytical methods for the determination of biological and therapeutic potency

• manufacture of master cell banks and working cell banks from primary and immortalized cells
• studies to optimize the inoculum for the use of bioreactors
• GMP compliant equipment qualification and process validation
• manufacturing and quality control of MSC-EV
• purification and characterization of EVs from human platelet lysate (HPL)