Manufacturing facility for a biopharmaceutical: Monoclonal antibody

Abstract

The objective of this preliminary design was to determine the technical and economic feasibility of constructing a biopharmaceutical production facility to produce humanized monoclonal antibodies from Chinese Hamster Ovary cells. The mAb production facility will need to produce a minimum of 1,000 kg of product a year at current titers of 1-2 g/L of mAb as well as at future titers of 5-10 g/L.

The team performed the preliminary design of the production facility based on the mAb production block flow diagram provided by The Company’s management as well as the physical specifications of the CHO cell line. The final optimized design includes a seedtrain process to promote controlled cell culture growth, two mAb production bioreactors, a protein harvesting and downstream purification process, frozen storage, and a waste inactivation process. One of the major considerations taken by the design team was the sterile nature of the process. In order to provide a sterile environment for each step in the process, a water for injection production process was designed, as well as a comprehensive steam in place and clean in place system. The process designed proves technical feasibility of the project in meeting physical, safety, and health specifications.

The facility is estimated to require 44 operating personnel working at any given time in order to ensure safe operation. As a batch process, raw material handling presents both a safety hazard and biohazard. In order to mitigate either of these concerns, viral inactivation and assays are performed throughout the process, and storage of caustic and acidic buffers is minimized.

The economic analysis performed for the process proves that the project is economically attractive. The economic parameters show that the project’s economic results far exceed the requirements for the project to be economically successful. The team suggests that The Company move forward with this project, as it is both technically feasible and economically attractive.