Exergetic Sustainability Assessment of the Value Chain of a Biotechnologically Manufactured Drug Compound Wouter De Soete*, Ana Gabriela Gamiz, Jack De Graaf, Bert Heirman, Jo Dewulf Presenting Author: Thomas Schaubroeck July, 13th 2015, SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
Janssen Pharmaceutica NV EHS² - Product Stewardship Group
Janssen Biologics
In collaboration with the
Ghent University
Department of Sustainable Organic Chemistry and Technology
Contents • Introduction: Research group and focus • Scope & Objective • Methodology • Results and Discussion
• Research Outlook
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
13.07.2015
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Introduction – Research group and focus
Introduction: Research group and focus Ghent University: Department of Sustainable Organic Chemistry and Technology
Analytical Environmental Organic Chemistry
Abatement of Organic Micropollutants
Clean Technologies, Process Engineering and LCA
Environmental Resource Management
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
13.07.2015
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Introduction: Research group and focus Fine Chemical and Pharmaceutical Sector
Retail Sector Agricultural and Ecosystem Management
LCA Case Studies
Input/Output Analysis
and Methodological Advances
Textile Sector
Resource Consumption Analysis/ Process Analysis
Biorefineries
Intersectoral Sustainable Supply Chain Management (SSCM)
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
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Scope & Objective
Scope & Objective Functional unit: 0.5mL of product
Raw materials extraction
Resources
End of life
API production
Final formulation and filling
Use
Distribution and transport
Packaging
Emissions
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
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Scope & Objective Purification processes
Cell culture processes
LCA studies |
27.05.2014
8
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
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Methodology
Methodology: hotspot analysis • Resource accounting: How to quantify all different kinds of resources: Energetic & material resources? Exergy Analysis (EA) & Exergetic Life Cycle Analysis (ELCA, e.g. CEENE Method) Entropy prod.
Exergyin
Resources
Exergetic efficiency
Waste
Exergyloss
ExergyWaste Exergyout
Product
ExergyProd
(Dewulf et al., Environ. Sci. Technol., 2008)
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
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Results and Discussion
Results: Hotspot Analysis
Exergy input (MJex/0.5mL)
3,50
α level
β level
γ level
3,00 2,50
Medium 2,00 preparation
Results
1,50 1,00
Buffer preparation
Fermentation
0,50 0,00 α-1 α-2 α-3 α-4 α-5 α-6 α-7 α-8 α-9 α-10 α-11 α-12 α-X
Cell culture processes
Purification processes
Results: Hotspot Analysis
Exergy input (MJex/0.5mL)
3,50
α level
β level
γ level
3,00 2,50 2,00
Results
1,50
5 % less resources
1,00
DPC
0,50
Transport from Leiden to Cork
0,00 α-1 α-2 α-3 α-4 α-5 α-6 α-7 α-8 α-9 α-10 α-11 α-12 α-X
Cell culture processes
Purification processes
Results: Resource Footprinting Cumulative resource consumption: 6 MJex/0.5mL STELARA® 35%
50%
Buffers/medium/cleaning/disposal
Disposables Electromechanical/mechanical Heating media
Biological culture Cooling media
78%
Abiotic renewable resources Fossil fuels Nuclear energy Metal ores Minerals and mineral aggregates Water resources Land occupation Atmospheric resources
Discussion • Hotspot Breakdown: Buffer preparation (36%), fermentation (21%) and medium preparation (21%) consume most resources through the three levels • Electricity (50%) (mainly for HVAC) and chemicals and nutrients (35%) are the categories that represent the highest resource consumption
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
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Lessons Learned/Best Practices •
Highest contribution to fossil/electricity consumption: HVAC is the +-20 times air recycling/h (depending on GMP area) necessary? ISPE Belgian Affiliate & GSK & UGENT; reducing by 30-40% almost reduces cumulative E consumption by 30% (HVAC major hotspot)
•
Continuous freeze drying and continuous downstream chromatography IN-LINE in development Process Intensification
•
Both SM and LM API production have a high burden when it comes to fossil fuels, however SM; Chemical SC LM: HVAC!
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
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Research Outlook
Research Outlook • Substantial knowledge creation on environmental impact of API LM synthesis processes • Disposables vs single use equipment vs stainless steel equipment? • Need to move downstream in supply chain: what about distribution networks? Logistics? Use phase? Waste management? • Take into account other impacts as well (‘Human Health’, EU PEF impact categories)
SETAC Europe 21st LCA Case Study Symposium, Nisyros, Greece
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[email protected]
Thank You !
Q/A
Janssen Pharmaceutica PDMS – Technical Operations - EHS²
Ghent University Dep. Env. Organic Chemistry and Technology
