Technology enhanced biopharmaceuticals development and manufacturing (TEnBioDev)

全球制药行业正在经历一场根本性的转变，从合成的小分子药物转向生物生产的蛋白质治疗剂。蛋白质治疗剂与传统药物相比具有许多优势，大多数源于这样一个事实，即它们可以精确地针对其预期的分子靶标，即使在细胞的极其复杂的环境中。这使得蛋白质治疗剂既高效又不容易产生副作用。因此，全球蛋白质治疗剂市场在过去二十年中迅速增长，2017年单类蛋白质治疗剂-单克隆抗体-达到960亿美元/年。再加上更大的疫苗市场（其中大部分是蛋白质治疗剂）和其他基于蛋白质的“生物制药”的组合市场，蛋白质治疗剂的总市场每年延伸到数十亿美元。加拿大拥有许多蛋白质治疗开发领域的国际领导者，如疫苗开发商赛诺菲巴斯德（Sanofi Pasteur），以及Treventis和ImmunoBiochem等创新生物技术初创公司，因此加拿大有能力在这一新兴行业中实现并保持全球领导地位。然而，充分利用这个机会将需要实施加拿大独有的蛋白质疗法开发新技术，从而为在这里进行研发的制药公司提供特殊的竞争优势。 “技术增强的生物制药开发和制造”（TEnBioDev）计划旨在实施新的加拿大生物分析技术，以加速临床前开发并实现蛋白质治疗剂的精确制造。该倡议将加拿大仪器制造商SCIEX开发的平台，通过主要在约克大学掌握的独特技术、方法和专门知识，与加拿大研究活跃的生物制药公司Sanofi Pasteur、Treventis和Immunobiochem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.