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，大多数优势源于这样一个事实，即即使在极其复杂的细胞环境中，蛋白质疗法也可以精确地针对其预期的分子靶点。这使得蛋白质疗法既非常有效，通常也不太容易产生副作用。因此，过去20年来，全球蛋白质疗法市场一直在快速增长，2017年，一种蛋白质疗法--单抗--的价格达到了960亿美元/年。再加上更大的疫苗市场(其中大部分是蛋白质疗法)以及其他以蛋白质为基础的“生物制药”市场，蛋白质疗法的总市场将延伸到每年数十亿美元的规模。加拿大拥有多家蛋白质疗法开发的国际领先者，如疫苗开发商赛诺菲·巴斯德，以及创新型生物技术初创公司，如Trevens和免疫生物化学，加拿大处于有利地位，可以在这个新兴行业实现并保持全球领先地位。然而，要充分利用这一机会，将需要实施加拿大独有的蛋白质疗法开发新技术，从而为在加拿大进行研究和开发的制药公司提供特别的竞争优势。“技术增强型生物制药开发和制造”(TEnBioDev)计划旨在实施加拿大新的生物分析技术，以加快临床前开发，并使蛋白质疗法的精密制造成为可能。该倡议通过主要在约克大学拥有的独特技术、方法和专业知识，将加拿大仪器制造商SCIEX开发的平台与加拿大研究活性生物制药公司赛诺菲·巴斯德、特雷万特和免疫生物化学公司的药物开发管道联系起来。

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.