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 cell culture medium as an extraction solvent. The team used mass spectrometry to analyze semivolatile and nonvolatile compounds, trace elements, and organic solvent residues. One statistical analysis method clustered the bags’ data into groups based on the date of manufacture, most likely due to different types of polyethylene used to make the bags.
by Celia Arnaud |
July 12, 2018