Analyzing what single-use bags release

Abstract

The biotech industry is beginning to replace metal vats in the manufacturing process with single-use plastic bags. But concerns remain about whether compounds could leach out of the films inside the bags. Such compounds could negatively affect cells during biomanufacturing or persist through purification processes and end up in protein drug formulations, causing a potential risk to patients. A team led by Jonathan Bones of the National Institute for Bioprocessing Research & Training, in Ireland, has measured the compounds released by 34 single-use bags from five suppliers (Anal. Chem. 2018, DOI: 10.1021/acs.analchem.8b01208). The team looked for two kinds of molecules: extractables, which represent all possible compounds that could be released, and leachables, which would be present only under normal conditions. To identify the extractables, the researchers extracted bag films with four solvents chosen to represent potential worst-case scenarios in biomanufacturing. They obtained the leachables by using c...