1. Filling Gaps during Carbon Footprint studies to design Green Pharmaceuticals November, 2013

2. 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.

3. 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 FLASC TM ). FLASC TM delivers footprint estimations in minutes by using the available footprint data of the materials used in a synthesis. When data is not available, FLASC TM 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 FLASC TM is available in IJLCA 12(4) 272-280 (2007)IJLCA 12(4) 272-280 (2007)

4. 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)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

5. “Average” Global Warming Potential (GWP) per chemical type Material TypeDescriptionGWP (kg CO2e / kg Process Stream) OrganicOrganic chemicals excluding enzymes and plant extracts 2.685 InorganicInorganic materials excluding chemicals containing metals 1.386 Enzyme and Plant ExtractsIncludes natural-derived products and botanicals 12.92 Base MetalsInorganic materials that contain a metal different from lithium 10.18 LithiumAny chemical containing lithium11.18 These figures represent a broad range to chemicals and are only applicable to fill data gaps that will help 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).IJLCA 12(4) 272-280 (2007) For further explanation on how these numbers can be used go to OPRD, 17(2), 239-246 (2013).OPRD, 17(2), 239-246 (2013) Acknowledgement – GlaxoSmithKline for providing the GWP information.