Technology enhanced biopharmaceuticals development and manufacturing (TEnBioDev)

全球制药业正在经历一场根本性的变革，从合成的小分子药物转向生物生产的蛋白质疗法。与传统药物相比，蛋白质疗法有许多优势，其中大部分源于这样一个事实，即即使在极其复杂的细胞环境中，它们也能精确地指向预期的分子目标。这使得蛋白质疗法既有效又不容易产生副作用。因此，全球蛋白质治疗药物市场在过去二十年中一直在快速增长，2017年单类蛋白质治疗药物单克隆抗体的年销售额达到960亿美元。再加上更大的疫苗市场（其中大部分是蛋白质治疗药物）和其他基于蛋白质的“生物制药”的综合市场，蛋白质治疗药物的总市场每年将扩大到1000亿美元。加拿大拥有许多国际领先的蛋白质治疗开发公司，如疫苗开发商赛诺菲巴斯德（Sanofi Pasteur），以及创新的生物技术初创公司，如Treventis和ImmunoBiochem，加拿大完全有能力在这一新兴行业实现并保持全球领先地位。然而，充分利用这一机会将需要实施加拿大独有的蛋白质治疗开发新技术，从而为在这里进行研究和开发的制药公司提供特殊的竞争优势。

The global pharmaceuticals industry is undergoing a fundamental transformation, shifting from synthetic, small molecule drugs to biologically-produced protein therapeutics. Protein therapeutics have numerous advantages over conventional drugs, most stemming from the fact that they can be precisely directed at their intended molecular targets, even in the exceedingly complex environment of the cell. This makes protein therapeutics both highly potent and generally less prone to side-effects. As a consequence, the global market for protein therapeutics has been growing rapidly over the past two decades, reaching $96B /yr for a single class of protein therapeutic - monoclonal antibodies - in 2017. Add to this the even larger market for vaccines (the majority of which are protein therapeutics) and the combined markets for other protein-based 'biopharmaceuticals', and the total market for protein therapeutics extends well into the 100's of billions annually. Being home to a number of international leaders in protein therapeutics development, like vaccine developer Sanofi Pasteur, and innovative biotech startups like Treventis and ImmunoBiochem, Canada is well positioned to achieve and maintain a global leadership position in this nascent industry. However, fully capitalizing on this opportunity will require the implementation of new technologies for protein therapeutics development that are unique to Canada, and thus provide a particular competitive advantage to pharmaceutical companies that conduct research and development here. The 'Technology-Enhanced Biopharmaceuticals Development and Manufacturing' (TEnBioDev) initiative is aimed at the implementation of new Canadian bioanalytical technologies to accelerate pre-clinical development and enable precision manufacturing of protein therapeutics. The initiative links platforms developed by Canadian instrument manufacturer SCIEX, through unique technologies, methods and expertise held primarily at York University to the drug development pipelines of Canada's research-active biopharmaceuticals companies Sanofi Pasteur, Treventis and Immunobiochem.