Addressing an immediate manufacturing need of the therapeutic antibody industry - reduce viscosity to reduce cost.

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Therapeutic strategies involving human monoclonal antibodies (mAbs) are becoming increasingly prevalent. However, solutions of mAbs possess unusually high viscosity, caused by their self-assembly into clusters. This is a bottleneck for industry's ability to scale-up manufacturing and imposes product formats that require healthcare professionals to administer the mAb, both of which significantly increase cost. At present, the cost of mAb therapies can reach several thousands of dollars per year, which is prohibitive to their use - irrespective of how well they treat disease. There is thus an immediate and urgent need to address the manufacturing challenges posed by high viscosity. With preliminary data in hand, this Strategic project proposes unprecedented concepts to reduce mAb solution viscosity, which will revolutionize the therapeutic mAb industry. More specifically, with Axis Photonique Inc., we will explore the use of lasers to reduce mAb solution viscosity, which will facilitate production. In addition, with Altus Formulation Inc., we will develop additives that can reduce mAb solution viscosity, which will enable their injection using syringes (currently this is very difficult to achieve). This project represents an excellent opportunity to train HQP in this area, which is of great social and economic importance. The outputs of this project will constitute major technological advances that will reduce the cost of monoclonal antibodies and their corresponding therapies. It will ultimately make better drugs more accessible to sick Canadians and change therapeutic strategies, leading to better patient outcomes.