Process: multiple downstream operations
Product: monoclonal antibody (mAb)
Results: The aim of this study was to compare the classical mAb purification process with the innovative EASY process developed by Sanofi, which is operated in full flowthrough mode with single-use technology. Figure 1 shows a representation of both the classical and EASY processes.
a)
b)
Figure 1: Representation of (a) the classical mAb purification process and (b) the EASY process in the Basic Design application of Proxima®.
The two processes were then evaluated in terms of cost. The results are presented in Figure 2 for one production batch. It is seen that the EASY process allows a significant cost reduction. It was found that the cost reduction significantly depends on the number of batches performed, the EASY process being more advantageous for small number of batches.
Figure 2: Results of the cost evalution performed in the Eval application of Proxima® for 1 production batch.
Key message: The Proxima® suite can be used to perform high level cost comparison of different process options
Further reading: Process comparison in Ypso-Proxima: EASY by Sanofi vs. classical mAb purification process