Abstract
Continuous manufacturing is expected to increase the productivity of protein drug production. However, it is not easy to build the continuous process especially for downstream processing as many unit operations (chromatography and membrane filtration) are involved. An operation method known as flow-through chromatography (FTC) is considered to be an efficient method for separating two components as the flow is continuous. In FTC, a target protein is eluted from the chromatography column without adsorption whereas contaminants are strongly bound. Since at least two different modes of chromatography are needed in order to remove contaminants, two FTC columns have to be connected in order to build the continuous process. This is not an easy task since the mobile phase properties (pH, salt, buffer ions) are different for the two columns. In this paper, we investigated how connected FTC columns can remove impurities efficiently from the cell culture broth containing monoclonal antibody. It was found that the sequence (activated carbon - anion exchange chromatography - cation exchange chromatography) is most efficient when the mobile phase pH and conductivity were properly chosen.
Highlights
Protein drugs such as monoclonal antibodies are known to be very effective drugs for cancer treatment and autoimmune diseases
While the sample feed is continuously fed to the column, the impurities are adsorbed and the flow-through stream from the outlet contains purified monoclonal antibodies (mAbs) in flowthrough chromatography (FTC) (Fig. 3)
FTC is not a true continuous operation, it is regarded as a pseudo-continuous operation
Summary
Protein drugs such as monoclonal antibodies (mAbs) are known to be very effective drugs for cancer treatment and autoimmune diseases. MAbs are mainly produced in mammalian cells such as CHO cells. After the cell culture (upstream process), mAbs must be purified to a very pure form by using several chromatography and membrane systems. This process called downstream process (DSP) is said to be very costly because of several unit operations involved. One of the problems of mAbs is its high price. Continuous manufacturing is expected to reduce the cost of goods of mAb production.
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