Addressing an immediate manufacturing need of the therapeutic antibody industry - reduce viscosity to reduce cost.

满足治疗性抗体行业的迫切生产需求 - 降低粘度以降低成本。

• 批准号: 493874-2016
• 负责人: Gauthier, Marc
• 金额: $ 9.18万
• 依托单位: Institut national de la recherche scientifique
• 依托单位国家: 加拿大
• 项目类别: Strategic Projects - Group
• 财政年份: 2018
• 资助国家: 加拿大
• 起止时间: 2018-01-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=651610
• 关键词: Addressing; immediate; manufacturing; need; therapeutic

Therapeutic strategies involving human monoclonal antibodies (mAbs) are becoming increasingly prevalent. However, solutions of mAbs possess unusually high viscosity, caused by their self-assembly into clusters. This is a bottleneck for industry's ability to scale-up manufacturing and imposes product formats that require healthcare professionals to administer the mAb, both of which significantly increase cost. At present, the cost of mAb therapies can reach several thousands of dollars per year, which is prohibitive to their use - irrespective of how well they treat disease. There is thus an immediate and urgent need to address the manufacturing challenges posed by high viscosity. With preliminary data in hand, this Strategic project proposes unprecedented concepts to reduce mAb solution viscosity, which will revolutionize the therapeutic mAb industry. More specifically, with Axis Photonique Inc., we will explore the use of lasers to reduce mAb solution viscosity, which will facilitate production. In addition, with Altus Formulation Inc., we will develop additives that can reduce mAb solution viscosity, which will enable their injection using syringes (currently this is very difficult to achieve). This project represents an excellent opportunity to train HQP in this area, which is of great social and economic importance. The outputs of this project will constitute major technological advances that will reduce the cost of monoclonal antibodies and their corresponding therapies. It will ultimately make better drugs more accessible to sick Canadians and change therapeutic strategies, leading to better patient outcomes.**

涉及人单克隆抗体（mab）的治疗策略正变得越来越普遍。然而，单克隆抗体的溶液具有异常高的粘度，这是由于它们自组装成簇造成的。这是行业扩大生产能力的瓶颈，并强加了需要医疗保健专业人员管理mAb的产品格式，这两者都大大增加了成本。目前，单克隆抗体疗法的成本每年可达数千美元，这让它们难以使用——无论它们治疗疾病的效果如何。因此，迫切需要解决高粘度带来的制造挑战。有了初步数据在手，该战略项目提出了前所未有的降低单抗溶液粘度的概念，这将彻底改变治疗单抗行业。更具体地说，与Axis Photonique公司合作，我们将探索使用激光来降低单抗溶液的粘度，这将有助于生产。此外，与Altus制剂公司合作，我们将开发能够降低单抗溶液粘度的添加剂，这将使他们能够使用注射器注射（目前这很难实现）。该项目是培训该地区HQP的绝佳机会，具有重要的社会和经济意义。该项目的产出将构成重大的技术进步，将降低单克隆抗体及其相应治疗的成本。它最终将使患病的加拿大人更容易获得更好的药物，并改变治疗策略，从而改善患者的治疗效果