| Popis: |
Cell therapy is an evolving and exciting field with promising clinical potential. In order to allow commercial use of this therapy, the process has to be scaled up dramatically and automated. Furthermore, to meet current good manufacturing practice (cGMP) standards, in-process controls such as process parameters have to be constantly monitored and analyzed. Cell therapies are a mixture of different kinds of cells with different kinds of culture condition needs ranging from suspension to adherent cells with a wide range of different characterizations; no one platform can fit all types of cells. Nevertheless, to upscale and meet the cGMP requirements cells need to be cultured in a controlled and monitored environment such as a bioreactor. Choosing the correct solution for a specific cell is not an easy task; it has to take into account the batch size, the cells' quality attributes, and the available technologies' advantages, kinetics, and limitations. Downstream processing postculturing needs to be done correctly and defined precisely. This stage is usually the shortest stage but it is the most critical step in the process as any damage or contamination inflected to the cell during this stage will result in failure of the batch. Stress induced to the cells in this critical stage will reflect on the final product; therefore, care and attention to the technologies and processes used should be taken. This chapter summarizes the main bioreactor and downstream platforms used for cell therapy and highlights the main challenges. |
