Recently, companies engaged in Biopharmaceutical manufacturing have sought to reduce the environmental impact of manufacturing activities in order to meet corporate sustainability goals and to demonstrate commitment to global corporate responsibilities. The use of standardized metrics has emerged as a key methodology to quantify environmental impact and enable a comparison of the various approaches being taken toward sustainability. Several previous reports have described the utilization of a Process Mass Intensity (PMI) calculation which is a relative quantification of the amount of mass used to produce a mass unit of API (output). While this approach is an effective relative measurement tool for small molecule medicine production, its application in biopharmaceutical manufacture is primarily influenced by the use of water. Though the PMI approach is useful, especially in parts of the world where water scarcity is a major issue, it does not directly assess the carbon penalty associated with the manufacture of biopharmaceuticals.  Thus, there is a need for other metrics to be developed to enable a holistic approach to sustainability. We have previously introduced a Carbon Footprint (CF) metric that quantifies the amount of CO<sub>2</sub> released per mass of drug substance manufactured.<br/>This presentation will cover the application of PMI, CF, and a third, novel metric, Recycling Efficiency (RE), to comprehensively assess the environmental impact of several different GSK biopharmaceutical products as they progress from early to late phase clinical development.  The utility of the RE metric for quantifying environmental impact will be discussed. The presentation will also provide the wider context of efforts undertaken in recent years within GSK Biopharm to raise awareness of the impact of our product value chain on environmental sustainability and opportunities to reduce environmental impact.<br/>

Sustainability metrics: Driving environmental impact reduction for biopharmaceutical manufacturing activities

2019 Spring National Meeting

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