Monoclonal Antibody Manufacturing

Project Goal: Create a continuous process to manufacture monoclonal antibodies for metastatic breast cancer.

Treatment for certain breast cancers includes the combination of oral chemotherapy and HER-2 trastuzumab, which is a recombinant humanized IgG1 monoclonal antibody. Antibody manufacturing is processed as a batch system, which results in product inconsistency and requires charging and discharging between reactor batches. A continuous manufacturing simulation for monoclonal breast cancer antibodies addresses some of these issues.

This project modeled the behavior of a continuous stirred bioreactor and subsequent purification steps. The design takes into account eight processing steps – centrifugation, capture chromatography, low pH virus inactivation mixer, depth filtration, anion and cation exchange chromatography, small virus filtration and ultrafiltration. The process results in a mixture dried to a powder and stored for distribution.

High-performance liquid chromatography verified the final samples meet the desired concentration.