ECHA | Merck Biodevelopment SAS and FUJIFILM Diosynth Biotechnologies UK Limited Opinion Adopted for 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

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Broad information on use applied for: Triton™ X-100 (a mixture of homologous molecules of the 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated substance group) is used as detergent in a wash buffer during the purification process of G-CSF (Filgrastim) inclusion bodies. G-CSF is the precursor of PEG-Filgrastim, a biosimilar drug used to prevent the occurrence or reduce the duration of febrile neutropenia in cancer patients receiving immunosuppressive chemotherapy.

G-CSF protein is initially expressed in recombinant E. coli bacteria in the form of inclusion bodies - dense, solid intracellular protein aggregates. These inclusion bodies must be separated from culture-related impurities and from potentially immunogenic compounds (mainly by-products of the cell’s metabolism such as bacterial endotoxins, host cell proteins and residual host DNA).


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