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