Below is a synopsis of the advantages of 3d vs 2d
Pluristem’s products are placenta-derived adherent stromal cells. Placenta-derived cell therapies are allogeneic in nature and are intended to be manufactured in commercial quantities for off-the-shelf use. To fully harness the potential for commercial manufacturing of allogeneic cells, process scalability should involve scale-up and scale-out aspects.
Most of today’s cell therapy production platforms are based on 2D technologies, such as cell factories or cell stacks. The major drawbacks of these technologies are limits in the total number of cells that can ultimately be produced, significant increases in cost of production, and poor control over culture parameters, which can lead to batch-to-batch variability. Due to the limitations of the standard 2D technologies, some companies use microcarrier-based bioreactor systems to grow their product.
Microcarrier platforms are considered more like 2D rather than 3D platforms due to the substantial difference between the cell size and the carrier curvature. Although this system is more controlled than common 2D systems, the real manufacturing challenge consists of the shear forces acting on the cells during culturing and harvesting, which compromise cell yield and quality.
Pluristem developed a bioreactor platform that uses macrocarriers (Fibra-cel Discs) in a packed bed configuration. The Fibra-Cell discs are composed of non- woven polyester fibers creating a 3D web- like environment, enabling a fast cell attachment (more than 90% in less than 1 hour). During the seeding of cells onto carriers, cells attach to the fibers and start se- creting Extra Cellular Matrix components between the fibers, increasing the surface area available for cell growth and creating a 3D environment that is more like these cells’ natural environment.
The combination of the unique growth environment in a packed bed with a specially designed impeller provides shielding from shear forces during growth, protecting the cell quality. Furthermore, in order to have a complete manufacturing solution, Pluristem developed an automated bioreactor harvesting device that controls harvest- ing parameters and can adjust them to different products.
The system provides high cell recovery while maintaining cell quality, and also enable automated monitoring and adjustments of physical and chemical factors that can affect cell growth, such as pH, dis- solved oxygen, and temperature, thereby reducing batch-to-batch variation to levels not achievable by traditional platforms.
