Monoclonal Antibodies (Mab)
Applications in the production of monoclonal antibodies including clarification, DNA and HCP reduction, and sterilizing grade filtration.
Monoclonal antibodies were among the first biotechnology produced drugs approved by the FDA. They are used to treat specific diseases, as ligands in purification schemes and for use as diagnostic reagents. The primary method of monoclonal antibody production involves using murine systems to produce antibodies to specific (human) antigens. The antigens can be nucleic acid or protein molecules associated with a disease state and the antibodies directed against these antigens are exquisitely specific and identical in structure and function. In order to produce large quantities of monoclonal antibodies, the cells or genes producing the antibodies are fused with cells, typically mammalian, able to be continuously grown in suspension cell culture. The resulting cells are called hybridomas. Many monoclonal antibody producing cell culture systems transport the expressed monoclonal antibodies into the cell culture medium. The purification process begins by separating the monoclonal antibody proteins from the cell mass followed by multiple chromatographic and filtration unit operations.
Filtration issues associated with the processing of monoclonal antibody production can be segmented into the following categories: media filtration, cell separation, clarification, chromatography column protection, and final sterilizing filtration.
The following table outlines 3M Purification solutions for various process steps.