Introduction
Scale-up process involves the development of culture systems in stages from (small scale) laboratory to (large scale) industry. There are currently three main options available for scaling up adherent cell production, including keeping a 2D surface with some form of plate-based system; using microcarriers in stirred tank bioreactors and using some form of 3D technology where a sophisticated scaffold is used to hold the cell.
To generate larger cell amounts, scale-out of the 2D approach has been suggested simply by multiplying culture dishes or by using multi-layered flasks. This method provides on the solution for both large autologous batches and small, allogenic batches containing a few billions of cells per batch, it would keeping a manufacturing lot size constant but multiplying the number of parallel unit operations. 3D culture is a potent approach to achieve the extensive cell number requirements. The bioreactor of 3D culture has a 3D scaffold structure based on a specific material such as nonwoven microfibers, a biopolymer, or a hydrogel, and the cells are entrapped in this fixed bed. This technology provides a good environment for the cells to grow in, because they grow within the fibers, the shear stress is limited.
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