Cell-based bioprocesses are used to produce a significant percentage of pharmaceutical products. The global biologics market is worth $281.69 billion. It is growing at 11%, double the rate of traditional pharmaceuticals and is predicted to be worth $399.5 billion by 2025 [1]. The ever-increasing demand for biologics production capacity coupled with the pressure on companies to produce their medicines more cheaply has resulted in a strong focus on process intensification. One intensification strategy is the improvement of the cell platforms used to produce the protein products, increasing peak cell densities and titres. As a result, the demands on cell culture media are ever increasing. Cell culture media must supply all nutrients to support cellular growth and production. The greater the cell density and product titre in a process, the greater the nutrient demand and the more challenging it is to achieve and maintain dissolution of the required concentrations of nutrients. Media preparation is affected by parameters such as mixing time, temperature, pH and addition order of the constituent components. Currently process development relies on trial and error due to the challenges associated with monitoring dissolution endpoint. The aim of this project is to develop the application of image analysis-based process monitoring using Canty’s technology in order to track the progression and endpoint of dissolution. The process understanding provided by the Canty technology will be then used to develop a process model for media prep which will be used as a digital twin in order to optimize cell culture media processes.
Project Funding: SSPC, the SFI Research Centre for Pharmaceuticals co-funding scheme in conjunction with JM Canty International
PhD Researcher: Claire Boles
PhD Supervisor: Jessica Whelan, Roderick Jones