Incorporating potential environmental impact from water for injection in environmental assessment of monoclonal antibody production

Environmental impacts associated with the manufacturing of personalised medicines: a scoping review

“…Two of these papers were industry-based, with authors from the third paper contributing from industry and academia. The findings of all three papers pointed to the large quantities of water being consumed during the manufacturing process-a finding corroborated by another article in our sample, Idris et al (2016), who used the modified Waste Reduction (WAR) algorithm, which considers the environmental impacts of a pharmaceutical design process before design or as a way to retrofit an existing process, to demonstrate similar findings (90). This compares with the environmental impacts of small molecule pharmaceuticals, which use less water but many more solvents (91).…”

“…Alongside the limited literature, when environmental assessments were reported or discussed, they often drew on a range of environmental metrics and methodologies. This heterogeneity is also visible in the broader pharmaceutical manufacturing literature (19,87,90,92,93). Life-cycle-assessments are viewed as a way to bring the assessment of environmental impacts together in a standardised way (64).…”

Technical Potential for Energy and GWP Reduction in Chemical–Pharmaceutical Industry in Germany and EU—Focused on Biologics and Botanicals Manufacturing

“…Biologics manufacturing is most often characterized by the monoclonal antibody (mAb) production platform process, as mAbs make up about 50% of all biologics. In many studies, the energy demand and environmental impact of biologics manufacturing have been evaluated by life cycle assessment; water for injection (WFI) has consistently been identified as a key factor [47][48][49][50][51][52][53][54]. While they are mostly used for chromatographic steps, typical product-specific volumes of cleaning-in-place (CIP) and sterilizing-in-place (SIP) are in the range of 4-20 m 3 WFI /kg mAb [48,50,[55][56][57][58].…”

“…In many studies, the energy demand and environmental impact of biologics manufacturing have been evaluated by life cycle assessment; water for injection (WFI) has consistently been identified as a key factor [47][48][49][50][51][52][53][54]. While they are mostly used for chromatographic steps, typical product-specific volumes of cleaning-in-place (CIP) and sterilizing-in-place (SIP) are in the range of 4-20 m 3 WFI /kg mAb [48,50,[55][56][57][58]. Idris et al showed that, for a large-scale 20 m 3 mAb process (titer 2 g/L), 1.9 m 3 WFI /kg mAb is used just for Protein A chromatography [50].…”

“…While they are mostly used for chromatographic steps, typical product-specific volumes of cleaning-in-place (CIP) and sterilizing-in-place (SIP) are in the range of 4-20 m 3 WFI /kg mAb [48,50,[55][56][57][58]. Idris et al showed that, for a large-scale 20 m 3 mAb process (titer 2 g/L), 1.9 m 3 WFI /kg mAb is used just for Protein A chromatography [50]. Overall process WFI usage accumulated to a total of about 4 m 3 WFI /kg mAb , so Protein A chromatography usage was about 47%, marking it, by far, the most GHG emission-intensive unit operation.…”