Systematic Evaluation of Single-Use Systems Using Process Simulation Tools - Simulation tools can reveal whether disposables will be economical even after scale-up. - BioPharm International

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Systematic Evaluation of Single-Use Systems Using Process Simulation Tools
Simulation tools can reveal whether disposables will be economical even after scale-up.


BioPharm International Supplements


Summary

Through an illustrative case study, this article demonstrated how to use process simulation tools to assist in the evaluation of process alternatives. Two options for buffer preparation and holding activities of a typical MAb process were analyzed from an economic perspective. The first used single-use buffer preparation and storage bags, whereas the second used traditional stainless-steel preparation and holding tanks. The single-use system proved to be more advantageous for smaller scales, whereas the stainless-steel option becomes more economical as the production scale increases. The evaluation results are specific to the MAb process analyzed. Additional process options and alternative technologies can be readily evaluated and compared using such tools.

Victor Papavasileiou is a senior applications engineer, Charles Siletti, PhD, is director of scheduling and planning applications, and Demetri Petrides, PhD, is president, all at Intelligen, Inc., Scotch Plains, NJ, 908.654.0088,

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