(460d) A Software Tool for Assessing the Financial and Technical Impacts of Changing Industrial Bio-Manufacturing Processes
AIChE Annual Meeting
2006
2006 Annual Meeting
Computing and Systems Technology Division
Process Design
Wednesday, November 15, 2006 - 4:18pm to 4:39pm
Growing pressures in the bioprocess industries are driving the need for simulations that rapidly evaluate strategies for achieving improvements in large-scale production. This paper presents a prototype simulation that evaluates the financial and technical impacts of developing and implementing a range of manufacturing changes to a pre-existing industrial process. The simulation evaluates each option with respect to development costs and timescales as well as annual production mass, cost of goods and batch times. These metrics are integrated together using a multi-attribute decision making (MADM) technique to produce a single value that quantitatively evaluates each strategy. The methodology is applied to development strategies being considered for an industrial process operated by Protherics U.K. Limited that manufactures an FDA-approved polyclonal Fab preparation for the treatment of rattlesnake envenomation. In the current process, an ovine serum feed containing anti-venom IgG is subjected to sodium sulphate precipitation to sediment the antibodies. The precipitate is separated from the contaminating supernatant by disk stack centrifugation, after which the IgG molecules are enzymatically digested by papain into their Fab and Fc components. The latter is removed from the process stream by passing it through an ion exchange column, after which the venom-specific Fab is recovered in an affinity step. Process changes considered include replacing the precipitation and centrifugation stages by a synthetic Protein A column step operating in either packed or expanded modes, eliminating the ion exchanger, raising the volume of the ovine feed and increasing the venom-specific IgG titre. Of all the changes examined, using an expanded bed column with the highest increase in IgG titre that could be achieved and the greatest feed volume that could be handled within the facility, combined with the elimination of the ion exchanger results in the best MADM-based value. This would therefore be the most desirable alternative to current operation.
Checkout
This paper has an Extended Abstract file available; you must purchase the conference proceedings to access it.
Do you already own this?
Log In for instructions on accessing this content.
Pricing
Individuals
AIChE Pro Members | $150.00 |
AIChE Graduate Student Members | Free |
AIChE Undergraduate Student Members | Free |
AIChE Explorer Members | $225.00 |
Non-Members | $225.00 |