Application Note

Rapid Development Of A Biosimilar Production Process Shows Dramatic Time Savings

Source: GE Healthcare Life Sciences
capsule_pill_and_molecule_450

This application note describes the rapid development of a production process for a biosimilar molecule, interferon α-2a, expressed in E. coli. Screening of modern chromatography media for downstream purification was done either with small packed columns and an ÄKTA™ avant system or with PreDictor™ plates (96-well pre-filled filter plates). Chromatography steps were optimized and tested for robustness using a statistical design of experiment (DoE) approach. Productivity of the downstream purification process was compared with hypothetical processes that used traditional chromatography media.