Ashutosh Sharma

Ashutosh Sharma is a process development engineer at Amgen, Inc.

A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.

Case studies were run to test Process Analytical Technology applications for protein refolding, diafiltration, and cation exchange chromatography. It is shown that it is feasible to design control schemes that rely on measurement of product quality attributes and thereby enable real-time decisions.