Monoclonal antibodies manufacture for cancer therapy

Abstract

Monoclonal antibodies (mAbs) specifically target a particular antigen. The increase in cases of diseases such as cancer has been the main cause of increased research within the field of therapeutic mAbs which have steadily grown to become a dominant product in the biopharmaceutical market. The objective is to develop a process for the manufacture of a monoclonal antibody, through a literature search, Bevacizumab has been selected. In clinical practice it is used for the treatment of multiple cancers and is the only one capable of slowing the growth of advanced stage epithelial ovarian cancers. Regulatory compliance is studied with reference to the main aspects of safety and hygiene, based on state and international public regulations and their subsequent application to the plant. The synthesis of the preparation process is the same for all mAbs, consisting of upstream cultivation stages, with four reactors in series of increasing size for fermentation and subsequent centrifugation, and downstream purification stages, with first filtration, followed by the corresponding chromatography’s and finally ultrafiltration. Basic design of the manufacturing plant was carried out using Aspen Batch Process Developer program. Operations defined in synthesizing chapter were introduced in program for a batch load of about 50 kg, and equipment from local suppliers was selected. Aspen scheduling shows that upstream process is time limiting, and that 20 batches/year can be carried out resulting in a production of about 1000 kg mAb/year