Scale of Operation
Figure 3
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By combining the impact of titer and bioreactor scale (Figure 3), maximum savings are seen at low volume and low titers. Some
savings are seen even at a very large scale of operation. As the batch moves through downstream operations, the scale reduces
such that even for the large-scale operations, some of the final purification stages can use disposable technologies.
Processing Options
Figure 4
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We can examine not only scale but also methods of operation. In this final example, we examine the impact of using concentrated
buffers to see how this varies with scale. In this case, we are looking at the impact of reducing buffer hold volumes. Given
that the buffer hold bags contribute significantly to the operation, as we make more use of concentrates we shift more of
the hold capacity into disposable systems for any given plant capacity. As the use of hold bags increases, the savings increase.
For the 2,000-L case, using concentrated buffer provides an additional saving of 3% (Figure 4). The benefits of using concentrated
buffers are seen throughout the scale range; for large-scale biorecators at 2 g/L, storing concentrated buffers in disposable
bags reduces CoGs by 10% compared to storing them in stainless steel containers.
CONCLUSIONS
Our aim in this article is to show how cost modeling can give valuable insight into the cost impact of disposable technologies
on biomanufacturing operations. It allows you to quantify the benefits and understand how savings arise and how savings are
affected by changes in scale or operation. More importantly, it can aid decision-making by focusing on the technologies that
provide the maximum benefit, because you can then use this information to negotiate with suppliers to further reduce costs.
In an article of this nature, we can only highlight some of the applications. There are many more opportunities analyzing
the impact of these technologies on specific processes and evaluating different vendor offerings for the same application.
The actual savings seen will depend on the specific process, geographical location, local costs, and technology mix. As we
have demonstrated, however, a cost analysis provides insight to support strategic decision-making when evaluating all these
options.
Andrew Sinclair is the managing director and Miriam Monge is the vice president of marketing and disposables implementation, both at Biopharm Services, Chesham, Bucks, UK, +44 1494
793 243,
disposables@biopharmservices.com
Miriam is also the European chair of ISPE's Community of Practice for Disposable Technologies.
REFERENCES
1. NICE turns nasty. The Economist. 2008 Aug 21.
2. The evidence gap. British balance benefit vs. cost of latest drugs. New York Times. 2008 Dec 3.
3. Biopharm Services estimate.
4. Sinclair A, Monge M. How to evaluate the cost impact of using disposables in biomanufacturing. Biopharm Int. 2008;21(6):26–30.
5. Morrow KJ. Industrial-scale antibody production strategies. Gen Eng News. 2002;22(17):8–71.
6. Hoff R. The manufacturing benefits of combining PER.C6 high density cell culture with disposable technologies. Disposable
Solutions for Biomanufacturing. London, UK; 2008 Nov 10–11.
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