Thrust:

 

PROJECT 2: Exosome protein and cell surface signature: a critical quality attribute for CMaT

Test-Bed Involved: MSCs

 

Exosome secretion profiles from cells change because of disease conditions, cell stress or functional changes.  Exosome profiles could provide rapid information on cell sources and how the cells are manipulated and expanded. Exosome monitoring could add a new attribute, not previously explored in cell manufacturing. Exosome characterization is being used as a disease diagnostic system for humans. Exosome characteristics could be a relatively fast and accepted CQA, because CD markers on cells are already linked to desired product quality.

Aim 1: Determine the variation in signatures in at least one test bed with assistance from industry partners.

Aim 2: Determine the variability in exosome signatures among spent media obtain from different sourced cells within a testbed.

Aim 3: Determine the variability and the speed of change in exosome signatures while cells are stressed.