Within the ACS GCI Pharmaceutical Roundtable (GCIPR), member companies adopted Process Mass Intensity (PMI) as a standard green metric over five years ago. PMI provides a quick and simple method to calculate the material intensity of a process where the sum of all input materials in kg is divided by the total amount of API produced in kg. Biopharmaceuticals (or biologics) are a rapidly growing segment of the pharmaceutical market, as such; the environmental footprint of their manufacture is coming under scrutiny. Biologics are manufactured through a fermentation-based process followed by several chromatography purification processes resulting in significant water use and large quantities of raw materials and consumables. To understand the environmental impact of biologics manufacture, the BioPharma Focus Group, a subset of GCIPR member companies, created a biologics-specific PMI metric. The biologics PMI measures the amount (in kg) of water, raw materials (media, buffer, etc) and consumables (filters, membranes, etc) utilized in the manufacture of biologics (kg API). This presentation will cover the initial PMI benchmarking study of the GCIPR which focused on monoclonal antibodies (mAb) from both commercial and clinical scales. The data highlight the material intensity of standard unit operations and the effect of cell culture methods. Additionally, the development of a similar metric focused the impact of cleaning and sanitation methods will be discussed.

Mining process data to improve environmental impact of biomanufacturing

255th National Meeting (2018)

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