Service

Small New World Laboratories develops and manufactures new cell-based therapeutic products (ATMPs and biologicals) including multipotent stromal cells (MSCs), extracellular vesicles (EV) and exosomes.

• manufacturing 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)

Upstream Technology

Contract development and contract manufacturing of Upstream Technology for

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

Downstream Technology

Contract development of Downstream Technology for

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