Grants and Contributions:

Grant or Award spanning more than one fiscal year (2017-2018 to 2018-2019).

Therapure Biopharma Inc. (or Therapure in short) already developed a highly competitive product, referred tox000D
here as "TBI-HSA", which is a therapeutic albumin designed for the cost-effective treatment of hypovolemiax000D
and the control of oncotic pressure in surgical applications. Therapeutic albumin is also undergoing phase IIIx000D
clinical trials based on its potential use for treating dementia in Alzheimer's patients. The TBI-HSA biologicsx000D
is a viable alternative to traditional albumins obtained through Cohn's fractionation of pooled human plasmax000D
and the prospect of future growth is excellent due to the rapidly aging population of Canada and the projectedx000D
increase in demand for plasma biologics during surgeries. In order to fully exploit the full potential of thex000D
technology developed by Therapure for growth in these markets, it is essential to understand at the molecularx000D
level how the manufacturing process of TBI-HSA affects the active ingredient of this formulation, i.e. thex000D
albumin protein. Here, we propose to determine through advanced Nuclear Magnetic Resonance (NMR)x000D
spectroscopy methods how a critical step of the TBI-HSA manufacturing process, the addition of stabilizers tox000D
enhance albumin stability, perturbs the interactions of albumin with common drugs, such as naproxen andx000D
warfarin. Considering that alteration in these interactions affects the ability of albumin to function as ax000D
biotherapeutic, the molecular images provided by NMR will inform the future optimization of thex000D
manufacturing process implemented by Therapure. This type of optimization will provide Therapure a uniquex000D
competitive edge relative to its international competitors and thus will help Therapure significantly expand itsx000D
worldwide market. However, Therapure currently has no access to the specialized NMR expertise required tox000D
gain this competitive edge. The Melacini group will provide the necessary expertise, as Dr. Melacinix000D
specializes in the biophysical characterization of proteins by NMR. The application of these NMR imagingx000D
methodologies to monitor how the TBI-HSA active ingredient changes during the manufacturing process willx000D
allow Therapure to further expand its share in the plasma biologics market.