Liaison(s): Zhorzh Patatanyan, Wiam Turki-Judeh, Alexander Zaydenberg
Takeda is a global pharmaceutical company which specializes in three core therapeutic areas; gastroenterology, oncology, and neuroscience. One subset of Takeda’s diverse pipeline includes the development and manufacture of blood-derived therapeutics for the treatment of rare diseases. For example, plasma fractionation is the method utilized to extract plasma-derived therapeutics, but there is a need to improve the process to meet market demands, and this can be accomplished through a better understanding of the manufacturing process.
The Team Master’s Project team was tasked to help Takeda move towards a data-driven approach in manufacturing process decision-making by assessing the use of innovative technologies such as process analytical technology (PAT). Incorporation of PAT would allow for; 1) improved process understanding, 2) establishment of a greater data-driven approach to decisions, and 3) real-time release of final or intermediate products to optimize the manufacturing process and enhance overall process capabilities. The TMP team has researched the technology landscape, conducted a series of experiments to assess the feasibility of implementing PAT in a small-scale fractionation process, and utilized PAT to gain a better understanding of the fractionation process.