Technologies to enable automated manufacturing of validated pharmaceutical hits****

点击翻译按钮获取中文摘要

Development of new drugs is a very slow and expensive undertaking that includes a sequence of risk-prone steps. The ultimate goal of the pharmaceutical industry is to transform early stages of drug development into an automated manufacturing process. The combinatorial approach is arguably the most promising means of achieving this goal. This approach starts with production of a combinatorial library, containing a billion different compounds, and followed by its step-by-step reduction to screening hits, validated hits, pre-clinical leads, clinical candidates, and, eventually, an approved drug. Obtaining a single approved drug requires thousands of validated hits -- compounds with confirmed binding to a therapeutic target. The very large number of required validated hits necessitates their automated manufacturing. Currently, validated hits are generated via a combination of research-grade processes, which cannot be streamlined into a manufacturing flow. Here we propose to resolve this bottleneck via development of a disruptive technology built upon robust processes that will facilitate automated manufacturing of validated pharmaceutical hits. The project will be carried out by an interdisciplinary academic team (Krylov's and Hili's groups at York University) in collaboration with two pharmaceutical companies (Alphora Research and GSK Canada) and an instrumentation-development company (SCIEX). The 3 companies participated in the feasibility study, which led to 5 joint publications, 2 patent applications, and an invention disclosure. The project is expected to generate: (i) new knowledge in several related areas of research, (ii) a highly-enabling practical technology, and (iii) industry-demanded skills for the trainees. The developed technology will be commercialized via licensing to the supporting organizations and other companies, potentially including a spin off company. Trainees will be hired by the supporting companies and other technology licensors. The use of the proposed manufacturing technology will lead not only to economic benefits but also to health benefits due to the faster introduction of new drugs.**********