CONCLUSION
In conclusion, biopharmaceutical manufacturing's current proliferation of capacity and the trend toward an increasing number
of small-volume products creates unique challenges in manufacturing economics studies. The high indirect costs of biopharmaceutical
manufacturing means that any plant downtime for retrofitting raise the bar for performance improvement efforts to overcome.
Typically, improvements with significant benefit to the organization focus on creating additional capacity (or additional
effective capacity, such as reduced changeover times). In such analyses, however, producing accurate process models is of
vital importance in establishing correct metrics around the economic benefits of any scenarios considered.
Rick Johnston is co-director at the Center for Biopharmaceutical Operations, University of California, Berkeley, and David Zhang is principal at Bioproduction Group, Inc. Berkeley, CA, 650.823.7533, rickj@berkeley.edu
REFERENCES
1. The University of California at Berkeley. Center for Biopharmaceutical Operations; 2009. Available frome: http://cbo.berkeley.edu/.
2. Numbers indicative only.
3. Bioproduction Group. Indicative times only, not from any specific single biopharmaceutical manufacturer. Comparative durations
for times retained, X and Y scales normalized. Processing step includes inline testing. Rejected batches removed.
4. Yang A. Genentech Simulation System. CBO Workshop; 21 May 2008. Available from: http://cbo.berkeley.edu/.
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