Technology-enhanced biopharmaceuticals discovery and manufacturing (TBioDM)

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The global pharmaceuticals industry is in a period of fundamental transition, moving rapidly from predominantly small molecule drugs to biological macromolecules (biopharmaceuticals). Today, for instance, 72% of Sanofi Pasteur's research and development projects are biopharmaceuticals. 'Discovery Phase' processes - in which it is determined if candidate molecules exhibit a target interaction - have largely adapted to this shift, however, this has only exacerbated an emerging problem: Biological macromolecules are fundamentally more challenging to characterize than small molecule drugs, so that when early-stage candidates are identified, it is exceedingly difficult to provide a rationale for further development based on a thorough understanding of the candidate, its complexation characteristics and its effect on living systems. This 'characterization gap', in which candidates are known to exhibit the desired interaction but nothing is known about the nature of the interaction (or often even the candidate itself), is a critical bottleneck in biopharmaceuticals development. It is also a significant risk to pharmaceutical companies who must make advancement decisions based on limited bioanalytical data. New technologies are emerging from research at York University that could close the characterization gap. These include tools capable of rapid, detailed structure and conformational stability analyses, quantitative measurements of binding interactions and comprehensive determinations of biopharmaceutical effects on living systems. The proposed research is aimed at the development and adaptation of these unique tools for characterization of 'real-world' biopharmaceuticals in industrial workflows. The program combines technologies and expertise from York, biopharmaceuticals from Sanofi Pasteur and cutting-edge analytical platforms from Sciex and Fluidigm Canada to deliver a complete solution to the 'characterization gap' bottleneck in biopharmaceuticals development.