CONCLUSION AND RECOMMENDATIONS
Table 3. Comparison of simulated and experimental results from an optimization.4
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Simulations can be used to identify critical process parameters and support process design and development by making a true
optimization with regard to pressure drop, flow rate, gradients, salt, pH, temperature, throughput, yield, purity, and robustness.
Applying these modeling tools in the development of chromatographic separations can support the design of effective and efficient
manufacturing processes that will consistently ensure a predefined quality at the end of the manufacturing process, consistent
with the basic tenet of Quality by Design.
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Oliver Kaltenbrunner is a principal scientist at Amgen, Inc., Thousand Oaks, CA. Justin McCue is a senior engineer and Philip Engel is a scientist of process development at Biogen Idec Corporation, Cambridge, MA. Jorgen M. Mollerup teaches at Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark. Anurag S. Rathore, PhD, is a director of process development at Amgen, Inc., Thousand Oaks, CA, 805.447.4491, arathore@amgen.com
He is also a member of BioPharm International's Editorial Advisory Board.
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