THE PROCESS IS THE PRODUCT: A NOVEL FULLY AUTOMATED, CONTROLLED, MONITORED AND SCALABLE 2D EXPANSION SYSTEM FOR ADHERENT STROMAL CELLS

The use of adherent stromal cells (ASC) from various origins for cellular therapeutics is expanding. The need for large quantities of cells of high quality becomes crucial as product candidates advance into clinical trials. At present most of the cell manufacturing is performed mostly using traditional 2D platforms (T-flasks or Cell Factories). Expansion using traditional 2D platforms is labor intensive and involves a large number of open manipulations. This process is poorly controlled and poorly monitored. In order to overcome these challenges, efficient, controlled, and repeatable manufacturing processes are required.

Pluristem has developed a fully scalable, controlled, monitored and closed 2D expansion system based on the Plurisphere macro carriers. The Plurisphere system is an efficient, repeatable and scalable technology which can produce high quality cells that can be used for both allogenic and autologous cell production under GMP conditions.

In this presentation, the characterization of a closed system utilizing Plurispheres for seeding and harvesting technique will be presented. Furthermore, the feasibility of the Plurisphere carriers to support the growth of ASC from several sources of and the characterization of placental expanded (PLX) cells grown using the Plurisphere system in comparison to PLX cells grown using the standard 2D growth platform will be presented.

Figure 1. Plurisphere system’s prototype.

Figure 2. MSC’s and tissue painted with Haematoxylin and Eosin on PS`s.