CONCLUSION
This case study demonstrates that integrating disposable and stainless steel technology in a hybrid model has economic benefits.
Using this approach in a 100 kg antibody production plant yielded significant savings in capital expenses, a key factor that
may determine the feasibility of an investment project for a small- or medium-sized company. The economic model also showed
lower operating costs for the hybrid project, compared to a project based on stainless steel, mainly as a result of lower
equipment-related costs and reduced demand for pharmaceutical water. The net present value of the hybrid project, calculated
over 10 years, was 68% higher than a similar project based on stainless steel technology.
ACKNOWLEDGEMENTS
We would like to thank Danilo Ponassi of Sartorius Stedim Biotech for his significant contribution to the introduction of
disposable technology in CIM processes over more than 10 years.
José M. País Chanfrau is the plant design engineer, Katia Zorrilla is a chemical engineer, and Ernesto Chico is the technical director, all in the Technical Direction department at the Center of Molecular Immunology, Havana, Cuba,
+53 7 271 3357, chico@cim.sld.cu
REFERENCES
1. Farid SS, Washbrook J, Titchener-Hooker NJ. Decision-support tool for assessing biomanufacturing strategies under uncertainty:
Stainless steel versus disposable equipment for clinical trial material preparation. Biotechnol Prog. 2005;21:486–97.
2. Darby N. Trends in biological manufacturing: How will our industry change in the next 10 years? 2nd Annual Bioprocess
Technology Seminar & Exhibition, Europe; 2008 June 23–25; Stockholm, Sweden. Available from http://www.asmeconferences.org/BioprocessEurope08/ASMEDarby.pdf
3. Lang HJ. Simplified approach to preliminary cost estimates. Chem Eng. 1948;55:112–113.
4. Petrides D. Bioprocess design and economics. In Harrison RG, Todd PW, Rudge SR, Petrides D, editors. Bioseparations science
and engineering. London: Oxford University Press; 2000.
5. Holland FA, Wilkinson JK. Process Economics. In Perry R, Green DW, Maloney JO, editors. Perry´s chemical engineers' handbook.
7th ed. New York: McGraw-Hill Co., Inc.; 1999.
6. Sinclair A, Monge M. How to evaluate the cost impact of using disposables in biomanufacturing. Biopharm Int. 2008; 1(6):26–30.
|
