John Wiley & Sons, Ltd.

Rational selection of alternative, environmentally compatible surfactants for biotechnological production of pharmaceuticals – A step towards green biotechnology

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Biotechnological production of pharmaceutical active substances needs ancillary substances. Surfactants are used at the end of the cell culture as a protection against potential viral or bacterial contamination and to lyse the producing cells for isolation and purification of the products. To find a replacement for a surfactant that had raised environmental concern, environmentally relevant data for potential alternatives were searched for in the literature. Significant data gaps were filled with additional tests: biodegradability, algal growth inhibition, acute daphnid immobilisation and chronic daphnid reproduction toxicity, acute fish toxicity and activated sludge respiration inhibition. The results were used to model removal in the wastewater treatment plants (WWTPs) serving 3 biotechnological production sites in the Roche Group. Predicted environmental concentrations (PECs) were calculated using realistic amounts of surfactants and site‐specific wastewater fluxes, modelled removals for the WWTPs and dilution factors by the respective receiving waters. Predicted no‐effect concentrations (PNECs) were derived for WWTPS and for both fresh and marine receiving waters, as the treated wastewater of 1 production site is discharged to a coastal water. This resulted in a spreadsheet showing PECs, PNECs and PEC÷PNEC risk characterisation ratios for the WWTPs and receiving waters for all investigated surfactants and all 3 sites. This spreadsheet now serves as a selection support for the biotechnological developers. This risk‐based prioritisation of surfactants is a step towards green biotechnological production. Environ Toxicol Chem © 2014 SETAC

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