ABSTRACT
Alemtuzumab is a humanized monoclonal antibody. It was constructed by combining a human IgG1 kappa antibody with complementarity-determining regions (CDRs) from a rat monoclonal antibody specific for the human CD25 protein. The rat antibody was obtained as a result of genetic manipulation to enhance its binding activity for antigen. Alemtuzumab is produced in mammalian cell culture by using CHO cells. The purification process includes affinity, cation exchange and size exclusion chromatography, and viral inactivation and removal steps. The final product is presented as a concentrated solution for infusion containing alemtuzumab (active), disodium edetate (EDTA), polysorbate 80, and phosphate buffered saline as excipients.
