Alternative strategies to the scaleup of animal cells.

The use of porous microcarriers has given manufacturers the option of having a high cell density/medium volume (10-100 L)/high specific productivity/long-term process. The advantages of the system are listed in Table 7 and many of the criteria listed in Table 1 are met. The question of being able to license products from continuous processes has been addressed and guidelines are being prepared. Methods are available to compare the master and end-of-process (extended) cell banks to ensure that no change has occurred to the cell or product. Rigid attention to process definition and validation, as well as to the definition of production lots, overcomes many of the other reservations. In conclusion, the method has been demonstrated as technically feasible, economically advantageous, and licensable and the many advantages of a high density perfusion process (listed in Table 8) make porous microcarrier technology an ideal scaleup process because it is a simple, reliable, and scalable system.