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Environmental sustainability assessment of the manufacturing process of a biological active pharmaceutical ingredient

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Abstract
BACKGROUND: Although the biopharmaceutical market grows rapidly, the environmental impacts of biopharmaceutical manufacturing have been hardly evaluated. The aim of the study is to comprehensively assess the environmental sustainability of a biologically-produced active pharmaceutical ingredient (API) manufacturing process. For this purpose, an exergy analysis and an (exergetic) life cycle assessment were performed using primary (foreground system) and modeled data (background system). Infliximab, a monoclonal antibody, was considered. RESULTS: The fermentation and its raw materials’ supply chain was determined to have the highest environmental impact, since the culture media requires chemicals and complex compounds such as animal-derived materials (ADMs). The total impact per 100 mg of API produced ranged between 18.6 and 101.8 MJex and 2.0–3.1 kg CO2-eq, mainly as a function of the ADMs’ source. A comparison of infliximab and ustekinumab, a biopharmaceutical produced without ADMs, showed that eliminating these materials can reduce the cumulative resource consumption of monoclonal antibody manufacturing by up to 7.5 times. The fermentation is the process taking the longest and the heating, ventilation and air conditioning system which support fermentation areas consumes approximately 75% of all plant electricity use. CONCLUSIONS: Culture media nutrients and cleanroom requirements are driving factors in the environmental impact of biological API manufacturing. Obtaining more precise data of the bioprocesses behind these nutrients’ supply chain is crucial to corroborating this study’s results
Keywords
Biotechnology, Fuel Technology, Inorganic Chemistry, Renewable Energy, Sustainability and the Environment, Organic Chemistry, Waste Management and Disposal, Pollution, General Chemical Engineering, active pharmaceutical ingredient, biopharmaceutical manufacturing, environmental impact

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Chicago
Rentería Gámiz, Gabriela, Wouter De Soete, Bert Heirman, Philip Dahlin, Steven De Meester, and Jo Dewulf. 2019. “Environmental Sustainability Assessment of the Manufacturing Process of a Biological Active Pharmaceutical Ingredient.” Journal of Chemical Technology & Biotechnology 94 (6): 1937–1944.
APA
Rentería Gámiz, G., De Soete, W., Heirman, B., Dahlin, P., De Meester, S., & Dewulf, J. (2019). Environmental sustainability assessment of the manufacturing process of a biological active pharmaceutical ingredient. Journal of Chemical Technology & Biotechnology, 94(6), 1937–1944.
Vancouver
1.
Rentería Gámiz G, De Soete W, Heirman B, Dahlin P, De Meester S, Dewulf J. Environmental sustainability assessment of the manufacturing process of a biological active pharmaceutical ingredient. Journal of Chemical Technology & Biotechnology. Wiley; 2019;94(6):1937–44.
MLA
Rentería Gámiz, Gabriela et al. “Environmental Sustainability Assessment of the Manufacturing Process of a Biological Active Pharmaceutical Ingredient.” Journal of Chemical Technology & Biotechnology 94.6 (2019): 1937–1944. Print.
@article{8617346,
  abstract     = {BACKGROUND: Although the biopharmaceutical market grows rapidly, the environmental impacts of biopharmaceutical
manufacturing have been hardly evaluated. The aim of the study is to comprehensively assess the environmental sustainability of a biologically-produced active pharmaceutical ingredient (API) manufacturing process. For this purpose, an exergy analysis and an (exergetic) life cycle assessment were performed using primary (foreground system) and modeled data (background system). Infliximab, a monoclonal antibody, was considered.

RESULTS: The fermentation and its raw materials’ supply chain was determined to have the highest environmental impact, since the culture media requires chemicals and complex compounds such as animal-derived materials (ADMs). The total impact per 100 mg of API produced ranged between 18.6 and 101.8 MJex and 2.0–3.1 kg CO2-eq, mainly as a function of the ADMs’ source. A comparison of infliximab and ustekinumab, a biopharmaceutical produced without ADMs, showed that eliminating these materials can reduce the cumulative resource consumption of monoclonal antibody manufacturing by up to 7.5 times. The fermentation is the process taking the longest and the heating, ventilation and air conditioning system which support fermentation areas consumes approximately 75% of all plant electricity use.

CONCLUSIONS: Culture media nutrients and cleanroom requirements are driving factors in the environmental impact of biological API manufacturing. Obtaining more precise data of the bioprocesses behind these nutrients’ supply chain is crucial to corroborating this study’s results},
  author       = {Rentería Gámiz, Gabriela and De Soete, Wouter and Heirman, Bert and Dahlin, Philip and De Meester, Steven and Dewulf, Jo},
  issn         = {0268-2575},
  journal      = {Journal of Chemical Technology & Biotechnology},
  keywords     = {Biotechnology,Fuel Technology,Inorganic Chemistry,Renewable Energy,Sustainability and the Environment,Organic Chemistry,Waste Management and Disposal,Pollution,General Chemical Engineering,active pharmaceutical ingredient,biopharmaceutical manufacturing,environmental impact},
  number       = {6},
  pages        = {1937--1944},
  publisher    = {Wiley},
  title        = {Environmental sustainability assessment of the manufacturing process of a biological active pharmaceutical ingredient},
  url          = {http://dx.doi.org/10.1002/jctb.5975},
  volume       = {94},
  year         = {2019},
}

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