Figure 6 presents a comparison of the total cost for the four different scenarios under consideration. Several key observations
can be made upon reviewing the data presented. First, option 1 (centrifuge + depth filtration) and option 2 (microfiltration)
are comparable under scenarios 1 and 2. For a small company that wants to minimize the capital cost, pursuing the microfiltration
route might be more attractive. The situation changes for scenarios 3 and 4, primarily because of the higher utility (purified
water) costs for microfiltration; option 1 becomes significantly more attractive. Second, the use of disposables is certainly
an economically viable option, especially for a smaller company that wants to minimize capital investment. Third, the total
cost per lot is significantly reduced once we start discounting the equipment cost for depreciation. This is the correct way
to perform an economic analysis for the cases where the equipment will be likely used by other products in the pipeline. Fourth,
in our case we did not see a significant cost reduction for a high-volume product because we limited the use of microfiltration
membranes to 10 cycles. However, for other applications (such as chromatography), where media can be reused for a much higher
number of cycles, significant cost reduction would be expected for a high volume product.
Figure 6. Comparison of total cost per lot under the four scenarios
For the biotechnology industry to continue being profitable, it is necessary to consider economics, along with the traditional
targets of process development—recovery, consistency, and product quality. Conducting a cost analysis of various process options
while the process is being developed can help ensure creation of economic processes. If process performance of the different
options under consideration is comparable, as in the case presented here, the optimal choice would depend on other "non-process"
factors. These include the size of the company and its product pipeline, the volume of its product, and the clinical advancement
of the program (clinical supplies versus commercial supplies).
While the results of the economic analysis are expected to vary with the application, the approach presented here can be useful
for biochemists and engineers performing cost-analyses in the biopharmaceutical industry.
The authors would like to acknowledge Oliver Kaltenbrunner and Darrell Lewis-Sandy, both from Amgen Inc., for useful discussions.
Anurag S. Rathore , PhD, is the director of process development at Amgen, One Amgen Center Dr., 30W-2-A, Thousand Oaks, CA 91320, 805.447.4491, firstname.lastname@example.org
Matthew Karpen is a senior engineer, process development, at Amgen.
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