Choosing The Right Tech To Optimize Processes And Reduce Costs For Therapeutic Proteins

A biopharmaceutical company aimed to develop a modified recombinant human blood clotting Factor Xa that could facilitate normal blood clotting even in the presence of Factor Xa inhibitors. While their small-scale manufacturing process using perfusion technology was initially successful, they encountered significant challenges in scaling production to meet commercial demands.

Although perfusion offered benefits like fewer process steps and smaller bioreactors, it presented scalability and cost limitations due to the continuous media replenishment and prolonged process duration. These challenges created a substantial risk for the drug’s market entry, as the high production costs could limit patient access. Recognizing the need for a more efficient, scalable manufacturing solution, the company sought a strategy that would boost productivity and reduce costs, ultimately ensuring that the therapeutic protein could reach patients in need more affordably.