Production Cost Analysis: Economic Analysis as a tool for Process Development: Harvest of a High Cell-Density Fermentation - For the biotech industry to be profitable, it must consider economics along

ADVERTISEMENT

Production Cost Analysis: Economic Analysis as a tool for Process Development: Harvest of a High Cell-Density Fermentation
For the biotech industry to be profitable, it must consider economics along with process recovery, purity, and product quality.


BioPharm International
Volume 19, Issue 11

OVERALL COMPARISON


Figure 6. Comparison of total cost per lot under the four scenarios
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.

CONCLUSION

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.

ACKNOWLEDGMENTS

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,
Matthew Karpen is a senior engineer, process development, at Amgen.

REFERENCES:

1. Agres T. Better Future for Pharma/Biotech? Drug Disc Dev. 2002 Dec 15.

2. Curling J, Baines D. The cost of chromatography. IBC conference on Production and Economics of Biopharmaceuticals. 2000 Nov 13–15; La Jolla, CA

3. Rathore AS, Levine H, Latham P, Curling J, Kaltenbrunner, O. Costing Issues in Production of Biopharmaceuticals, BioPharm Int. 2004 Feb; 17(2):46–55.

4. Ernst S, Garro OA, Winkler S, Venkataraman G, Langer R, Cooney CL, et al. Process Simulation for Recombinant Protein Production: Cost Estimation and Sensitivity Analysis for Heparinase I Expressed in Escherichia coli, Biotechnol Bioeng. 1997; 53: 575–582.

5. Sadana A, Beelaram AM. Efficiency and Economics of Bioseparation: Some Case Studies. Bioseparation. 1994; 4:221–235.

6. Warner TN, Nochumson S. Rethinking the Economics of Chromatography: New Technologies and Hidden Costs. BioPharm Int. 2003 Jan; 18(1): 58–60.

7. Novais JL, Titchener-Hookner NJ, Hoare M. Economic comparison between conventional and disposables-based technology for the production of biopharmaceuticals, Biotechnol Bioeng. 2001; 75:143–153.

8. Sinclair A, Monge M. Biomanufacturing for the 21st Century: Designing a Concept Facility Based on Single-Use Systems, BioProcess International. Part 1: 2004 Oct supp; 2–12; Part 2: 2005 Oct supp; 51–55.

9. Langer E, Ranck J. The ROI Case: Economic Justification for Disposables in Biopharmaceutical Manufacturing. BioProcess Int. 2005 Oct supp; 46–50.

10. Wang A, Lewus R, Rathore AS. Comparison of Different Options for Harvest of a Therapeutic Protein Product for High Cell Density Fermentation Broth. Biotechnol Bioeng. 2005;94:91–104.

11. Collentro A. Current Design Economics for USP Purified Water Generation Systems. Pharm Processing. 2004 Dec.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

PDA Announces Technical Report on Drug Shortages
September 9, 2014
European Commission Approves RoACTEMRA for Treatment of RA
September 9, 2014
DPT Laboratories Acquires Media Pharmaceuticals' Lakewood Facilities
September 5, 2014
Merck KGaA Breaks Ground on Facility in China
September 5, 2014
FDA Releases Guidance Electronic Submission of Lot Distribution Reports
September 5, 2014
Author Guidelines
Source: BioPharm International,
Click here