Downstream Process Development

Ø Protein purification from different expression systems, including E. coli, yeast, HEK293, CHO and etc.

Ø Platform technology to remove product-related impurities and process-related impurities.

Ø Process development and optimization based on QbD, including affinity chromatography, ion exchange chromatography, gel filtration chromatography, hydrophobic analysis and multi-mode chromatography.

Ø Virus inactivation and removal process development, such as low pH, S/D treatment and nanofiltration.

Ø Integrated development strategy and gap analysis for successful technology transfer from small scale to pilot scale.