Applying the process mass intensity (PMI) or E(nvironmental) factor concept originally developed for the chemical industry, the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable (ACS GCIPR) group reported their analysis of the overall greenness of pharmaceuticals production for 19 development projects from the company members. We later extended the work to cover the production of biotherapeutics. Unlike small molecule pharmaceutics, the PMI for water in biologics manufacturing was found to represent an important environmental metric. Two other relevant PMI parameters are for raw materials and consumables.  The analysis covered a range of process complexity and fermentation using either bacteria or mammalian cells.  The results obtained were contrasted with those reported by the GCIPR group for small molecule pharmaceutics.  Within the past year, a concerted effort called BioPharm Focus group under the auspices of GCIPR was formed to address the environmental impact of biologics manufacture and promote greener practices within the biopharmaceutical industry. As part of this effort, a set of spreadsheet-based, user-friendly templates is being developed to facilitate broad usage of the developed metrics.  Important environmental consideration of biologics manufacturing will need to include energy consumption, typically dominated by facility operations; some progress in this area will also be discussed.

Green metrics: From small molecules to biologics

248th National Meeting (2014)

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