원문정보
초록
영어
As Patents on the biopharmaceuticals, including many blockbusters with over $1 billion in annual sales, have expired or are about to approach expiry, development opportunity of subsequent biosimilars has emerged. And more recently, the researches on the next generation
of so-called super-biosimilars are also activated. In this report, we present the optimizations of Protein A capture step for the therapeutic Fc-fusion protein, as one of the super-biosimilars, to improve the yield. The optimizing method was designed by using a design of experiment (DOE) is that statistical tool. The six decision variables used in the optimizations were the component, pH and conductivity of equilibration buffer, residence time (linear velocity), the quantity of
loading samples, and pH of elution buffer. After all, an optimized procedure to obtain the therapeutic Fc-fusion proteins was developed.