Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes

The Process Analytical Technology (PAT) guidance is a scientific and regulatory framework issued in 2004 by the U.S. Food and Drug Administration for innovating and improving the pharmaceutical industry.;The implementation of PAT in the plasma-derived protein industry has been marked with delays due to regulatory and process complexities. This thesis demonstrates that the existing regulatory environment and technological advancements provide fertile grounds for the adoption of PAT in the plasma-derived industry. The paper presents regulatory guidance, which aids in resolving regulatory hurdles and promotes the adoption of PAT to harness benefits from the elimination of costly and time-consuming sample testing, revalidations, and submission reviews. This thesis shows that the technological advancements and tools developed for the biotechnology industry can serve as a basis for the implementation of PAT in the plasma-derived industry by overcoming process complexities, controlling variability, improving process understanding and control, increasing innovation, and reducing process waste.