In line with an overall industry trend, GSK Biopharm is implementing sustainability initiatives as part of corporate responsibility goals. Assessment of early- and mid-phase manufacturing activities affords an opportunity to review and reduce environmental impact throughout the product and process lifecycle, including commercial manufacturing. Accordingly, the GSK Upper Merion Biopharm Pilot Plant is actively assessing environmental impact by calculating both the process mass intensity (PMI) and Carbon Footprint of clinical trial material production. PMI calculations representative of the Biopharm Industry have previously been conducted and reported by the <i>ACS Green Chemistry Institute Pharmaceutical Roundtable, Biopharm Focus Group</i>. These have identified opportunities to mitigate environmental impact such as reducing water usage in Biopharm manufacturing operations. However, this methodology does not enable a comprehensive understanding of the corresponding energy utilization and associated Carbon Footprint.<br/>This presentation will illustrate how the Carbon Footprint calculation determines the total amount of carbon released to the atmosphere due to manufacturing activities (including all process reagents, components, and energy usage). Results of the calculation for multiple Biopharm manufacturing processes, including both early- and late-phase processes at multiple process scales, will be presented. Highlights of this analysis will include an illustration of the dramatic impact of bioreactor titer on environmental impact, and that raw materials and single-use components are minor contributors to the total carbon footprint. These highlights identify opportunities to reduce the environmental impact of future commercial Biopharm manufacturing activities and help outline a path to carbon neutrality for GSK Corporate activities. Additionally, the relative strengths and weaknesses of the PMI and Carbon Footprint environmental impact calculations will be discussed.

Use of a carbon footprint calculation to assess the environment impact of drug substance manufacture in GSK biopharm

255th National Meeting (2018)

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