GSK and Zeton Teams ‘Realize the Future’ with the Biopharm Continuous Processing Project
November 18, 2020
GSK’s Biopharm Continuous Processing Project is an example of an intensified processing approach, demonstrating what next generation production facilities might look like. The system was designed as an R&D system, enabling demonstration of proof of concept, process robustness, and a control strategy for continuous processes. Therefore, the skid was designed to be flexible to provide a testing ground for technologies to inform the direction of future production facilities.
The facility is capable of generating Drug Substance utilizing continuous and integrated operation of the production bioreactor and the vast majority of the purification steps. Unit operations are divided into separate modules with their own local control system. These steps can operate automatically, including the sanitization, start-up, steady state (with PAT facilitated process control), and shutdown steps. The automation was built around customizable parameters (e.g. flow rates, filter sizes, volumes, etc.), thus facilitating the flexibility to execute processes for different molecules across a range of throughputs. The modules also communicate with each other, which enables the plant to run continuously and respond to process interruptions without operator interaction.
During the project, the joint team of GSK and Zeton engineers faced a number of technical challenges. As a result of the team’s extensive knowledge of Biopharm, and Zeton’s ability as a technology integrator to bring different technologies together in an integrated process facility, we have succeeded in creating a continuous process incorporating off the shelf lab equipment and new processing technologies.
Continuous processing has the potential to increase the flexibility and efficiency in Biopharm manufacturing by significantly intensifying the process, requiring smaller equipment and facilities and reducing risks association with scale-up. Furthermore, the system was designed with a fully single use flow path which reduces capital equipment cost, significantly reduces the need for equipment cleaning, and enables process flexibility.
The process automation implemented in this project is unique. As one of the Zeton project members stated: “Zeton is proud that we have been able to successfully implement our customer’s aspirations towards automation and software, and with considerable flexibility. Through considerable effort from the controls teams, GSK’s operating requirements can now be fulfilled at the touch of a button.” The positive attitude and excellent cooperation between the project teams have made this possible, delivering the production facility of the future!
“Zeton’s engineers were extremely knowledgeable and eager to tackle challenges they hadn’t encountered in previous projects. They consistently proposed unique and thoughtful solutions, and were always flexible in meeting our user requirements, regardless of the difficulty or complexity. They were a pleasure to work with, and the result was a cutting edge facility that successfully incorporated a number of novel approaches to complex problems.” Dr. Mehdi Ghodbane, Ph.D., Scientific Leader, GSK