An Environmental Life Cycle Assessment Comparing Single-Use and Conventional Process Technology - The authors compare the environmental impact of monoclonal antibody production using fixed-in-place pr

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An Environmental Life Cycle Assessment Comparing Single-Use and Conventional Process Technology
The authors compare the environmental impact of monoclonal antibody production using fixed-in-place processing and single-use systems.


BioPharm International Supplements
pp. s30-s38

CONCLUSIONS AND RECOMMENDATIONS

The study has shown that a shift from traditional durable process technology to single-use process technology can result in substantial reductions in cumulative energy demand, global warming potential, and water usage for the production of monoclonal antibodies, in addition to improving flexibility and productivity. Although single-use process technology introduces a need for the production, distribution, and disposal of single-use components, this approach also reduces or eliminates the need for large quantities of steam, process water, and water for injection. The LCA model developed for this study is dynamic and offers the potential for further exploration of different bioprocess conditions and "what if" scenarios. The detailed insights gained in this comprehensive study offer the potential for further improvements in environmentally conscious product and process development for biopharmaceutical manufacturing.

Matthew Pietrzykowski is a research chemist, and William Flanagan* is the leader, both at at the Ecoassessment Center of Excellence, GE Global Research, Niskayuna, NY. Vincent Pizzi is a global product marketing leader at GE Healthcare, Westborough, MA. Andrew Brown is a bioprocess engineer, Andrew Sinclair is managing director, and Miriam Monge is vice-president, all at Biopharm Services Ltd., Chesham, UK. *

REFERENCES

1. C. Mintz, "Single-use, disposable products: A 'state of the industry' update", Life Science Leader, July 29 (2009), http://www.medicaldesignonline.com/download.mvc/Single-Use-Disposable-Products-A-State-Of-0001?user=20&source=nl:24985#, accessed Sept. 14, 2011.

2. M. Fuller and H. Pora, BioProcess Int. 6 (10), 30–36 (2008).

3. H. Haughney and J. Hutchinson, Gen. Eng. News, 24 (8) 2004.

4. L. Leveen, Amer. Pharma. Review, 12 (6), 72–78 (2009).

5. A. Sinclair et al,. supplement to BioPharm International 21 (11), s4–s15 (2008).

6. M. Mauter, BioProcess Int. 7 (3), 18–29 (2009).

7. B. Rawlings and H. Pora, BioProcess Int. 7 (2), 18–25 (2009).

8. ISO 14040, Environmental management —Life cycle Assessment—Principles and Framework, 2006.

9. ISO 14044, Environmental management —Life cycle Assessment—Requirements and Guidelines, 2006.

10. Dr. Pascal Lesage (researcher, CIRAIG), Dr. Dirk Böhm (director, large-scale biotech operations, Merck Serono), Ekta Mahajan (senior engineer, Genentech Inc.)

11. ecoinvent Centre, The Life Cycle Inventory Data version 2.2. Swiss Centre for Life Cycle Inventories (2010).

12. PRe Consultants, http://pre.nl/.

13. IPCC, "Climate Change 2007: The Physical Science Basis," contribution of working group I to The Fourth Assessment Report of the Intergovernmental Panel on Climate Change, S. Solomon, et al., Eds, (Cambridge University Press, Cambridge, United Kingdom, and New York, NY, USA, 2001).

CALL FOR PAPERS * CALL FOR PAPERS * CALL FOR PAPERS

BioPharm International integrates the science and business of biopharmaceutical development, and manufacturing. We provide practical, peer-reviewed technical solutions to enable biopharmaceutical professionals to perform their jobs more effectively.

We are currently seeking novel research articles for our peer-reviewed journal as well as manuscripts for our special issues. For peer-reviewed papers, members of BioPharm International's Editorial Advisory Board and other industry experts review manuscripts on technical and regulatory topics. The review process is double-blind. Manuscripts are reviewed on a rolling basis.

Our upcoming single-themed issues, which include literature reviews, case studies, and tutorials, will cover the following: outsourcing, expression systems, biopharmaceutical trends, and single-use and modular systems. Additional papers on separation and purification, cell therapy, protein characterization, platform technologies, and vaccines are welcome.

Please visit our website, http://www.BiopharmInternational.com/, to view our full Author Guidelines. Manuscripts may be sent to
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