Biosimilars represent an innovative solution that can benefit both patients and healthcare systems by reducing the burden of rising treatment costs. To improve the availability many countries are implementing strategies to establish their own production capacity. To support this development, mAbxience, a Spanish biotechnology company, is committed to provide the manufacturing of high- quality products and processes that meet regulatory and technical requirements in all countries where it operates.
This case study demonstrates the optimization of the downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein. The optimization work was conducted by Fast Trak scientists. Process optimization focused on improving the affinity chromatography (AF) capture step as well as the intermediate purification and polishing steps, using hydrophobic interaction chromatography (HIC) and anion exchange chromatography (AIEX), respectively, keeping the same process materials.