Horizon: Validation of an improved method for rapid characterization of protein aggregates in biologic drugs for increased quality and safety

Optofluidics and the University of Delaware propose to complete the development of the Horizon technology and carry out validation via a comprehensive multi-site study. The technology is a subvisible particle analyzer pioneered during Phase I. The technology is designed to fill two critical gaps in biopharmaceutical product development: (1) Scientists can count and image particles with current tools, but they cannot easily identify them which hampers their ability to minimize or eliminate them. (2) Early on in product development where sample volumes are extremely limited, particle analysis is rarely carried out, despite the desire to do so. This is because of the large volumerequirements and the slow nature of current techniques. The Horizon technology addresses these problems with a new imaging technique that can differentiate between important classes of particles. The analysis uses a tenth the volume of current techniques, is at least 10 times faster and is fully automated. The proposed research will involve internal validation followed by a multi-site study to show robustness and demonstrate the utility of the technique on real pharmaceutical samples at GSK. Horizon will speed up biopharma product development time and improve the quality and safety of biotherapeutics by enabling routine particle identification.