Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc.
Filling Gaps during Carbon Footprint studies to design Green Pharmaceuticals November, 2013.
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Transcript of Filling Gaps during Carbon Footprint studies to design Green Pharmaceuticals November, 2013.
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Filling Gaps during Carbon Footprint studies to design
Green Pharmaceuticals
November, 2013
![Page 2: Filling Gaps during Carbon Footprint studies to design Green Pharmaceuticals November, 2013.](https://reader036.fdocuments.us/reader036/viewer/2022072006/56649d135503460f949e7d9f/html5/thumbnails/2.jpg)
The Challenge
• Initiatives such as the Swedish Voluntary Incentive Scheme are focusing on eco-footprint/LCA of pharmaceuticals
• Data availability is a significant issue when estimating material carbon footprint or Life Cycle Assessments (LCA)
• Life Cycle Assessment research has repeatedly demonstrated that in API production, solvents play the biggest role.
• Pharmaceutical companies can access data for solvent and other materials by taking out a license to EcoInvent or similar database, but data gaps on research materials tend to be big.
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How this challenge has been overcome before?
• In the early 2000s GlaxoSmithKine (GSK) developed a streamlined Life Cycle Assessment Tool (Fast Lifecycle Assessment of Synthetic Chemistry – or FLASCTM).
• FLASCTM delivers footprint estimations in minutes by using the available footprint data of the materials used in a synthesis. When data is not available, FLASCTM fills the gaps using ‘average’ footprint estimations for a particular type of chemical.
• These ‘average’ footprint numbers were derived using a statistical methodology, and have proven to render acceptable levels or uncertainty for more than a decade within GSK.
• A description to FLASCTM is available in IJLCA 12(4) 272-280 (2007)
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How can the Roundtable help ?
• The ACS GCI Pharmaceutical Roundtable developed a PMI/LCA tool for estimation of Process Mass Intensity and Life Cycle Assessment
• The LCA estimation is based on the methodology published by GSK. • The PMI/LCA tool is described in OPRD, 17(2), 239-246 (2013)
• GlaxoSmithKline approved the release of ‘average’ Global Warming Potential (GWP, carbon footprint) data so data gaps can be filled.
• The roundtable companies agreed to use the PMI/LCA tool to benchmark their footprint.
• Companies outside the ACS GCI Pharmaceutical Roundtable can use the ‘average’ footprint numbers in combination with data from other sources (e.g., EcoInvent, proprietary data, literature) to estimate the footprint
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“Average” Global Warming Potential (GWP) per chemical type
Material Type Description GWP (kg CO2e / kg Process Stream)
Organic Organic chemicals excluding enzymes and plant extracts
2.685
Inorganic Inorganic materials excluding chemicals containing metals
1.386
Enzyme and Plant Extracts Includes natural-derived products and botanicals
12.92
Base Metals Inorganic materials that contain a metal different from lithium
10.18
Lithium Any chemical containing lithium 11.18
• These figures represent a broad range to chemicals and are only applicable to fill data gaps that willhelp to provide a high-level reasonable estimation of carbon footprint of Active Pharmaceutical Ingredients when solvent data is known. These figures most likely will not translate outside the API production.
• For further explanation of categories, go to IJLCA 12(4) 272-280 (2007).
• For further explanation on how these numbers can be used go to OPRD, 17(2), 239-246 (2013).
• Acknowledgement – GlaxoSmithKline for providing the GWP information.