Optimization of the Induction Solutions Preparation and Addition Process in Bulk Manufacturing at a Biopharmaceutical Plant

Abstract

An optimization of the induction solutions manufacturing and addition processes, used during the protein generation in a Cell Culture process is pursued at a Biopharmaceutical plant located in Juncos, Puerto Rico. Initiatives to improve the Cell Culture process are desired due to its extent, complexity, risks, and associated costs. The data collection for the project was segregated into two main areas: Media Preparation Area and Cell Culture Area; and focused on developing Process Flow Diagrams, Voice of the Customer (VOCs) exercises, durations analysis, and costs evaluations of the current processes. An optimized batch size of a combined induction solutions with High Temperature Short Time (HTST) treatment was implemented at the Media Preparation area; while in the Cell Culture area, a simplified addition process was implemented. The project achieved an increase in manufacturing capacity, implemented risk mitigation controls, reduced costs and man hours required for the addition process. Key Terms ⎯ cell culture optimization, continuous improvement, induction solutions addition, manufacturing competitiveness.