13TSB_TIBio: Technology Inspired Innovation Bioscience - Puridify

13TSB_TIBio：技术启发创新生物科学 - Puridify

基本信息

批准号：
BB/M004848/1
负责人：
Daniel Bracewell
金额：
$ 17.94万
依托单位：
University College London
依托单位国家：
英国
项目类别：
Research Grant
财政年份：
2014
资助国家：
英国
起止时间：
2014 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=BB%2FM004848%2F1
关键词：
13TSB_TIBio Technology Inspired Innovation Bioscience

项目摘要

This collaborative project between our leading academic group at UCL and SME Puridify gives the opportunity for a highly focused project with high level expertise to carry out the technologically innovative work described below aiming to address the established purification challenges during industrial manufacture of biopharmaceuticals. UCL and Puridify are supported in this activity by three industrial partners selected to provide support to the analytical and manufacturing aspects (being leading companies in their respective areas) as well as to provide a route to transfer the findings of the research to practice. The research collaboration described here is focused on the study of the performance of the core purification method used for the manufacture of biopharmaceuticals - chromatography. Specifically we seek understand the methods of immobilisation for this novel matrix material thereby allowing for optimised fabrication of functional adsorbent materials. This is an essential part of establishing a robust purification platform with a novel technology that offers significant operations advantages in terms of productivity, lifetime, feedstream complexity and indeed opportunity to facilitate continuous downstream operations. Biopharmaceuticals are an increasingly important sector of the pharmaceutical industry, over one third of all drugs now in development are biopharmaceuticals and they make up half of the top 10 revenue blockbusters. It takes over 10 years and $800 million to develop a new drug. The attrition rate for biopharmaceuticals is severe, only 9% at Phase 1 clinical trials reach the market and only 3 out of 10 drugs launched actually generate enough revenues to recoup development costs. Given the high attrition rate during development, companies are resistant to committing manufacturing resources at the early stages. The potentially significant manufacturing cost reduction that this technology is capable of reduces this early burden with significant external 'spill over' benefits. The new bioprocess purification technologies created here would continue to allow UCL to play their part in advancing manufacturing routes to the UK bioindustry while maintaining research at the forefront of industrial development. The UK bioprocessing sector is economically important, currently over 480 companies, employing 26,000 people and generating annual revenues of £4bn. The deliverables of this CRD project are a key step towards developing this technology for industrial implementation. The industry has to reduce costs to make biotherapeutics more widely available and to increase the amount of research in the area. Key objectives relating to UCL's involvement in this CRD project are listed below: - Expand knowledge and research activity in the area of purification within the department and UCL. - Disseminate this work by publishing papers with the aim of generating further research opportunities and increased collaborations. - Contribute to industrially focused developments of a new technologies and screening platforms. - Share knowledge through events such as MBI training courses, conferences and teaching. - Introduce new analytical techniques and develop leading technologies.

我们在UCL领先的学术小组和中小型企业Puridify之间的合作项目为具有高水平专业知识的高度专业项目提供了机会，以进行以下所述的技术创新工作，旨在应对生物制药工业制造过程中既定的纯化挑战。三个工业合作伙伴在这项活动中支持了UCL和PuriDify，他们选择为分析和制造方面（作为其各自地区的领先公司）提供支持，并提供了将研究结果转移到实践的途径。此处描述的研究合作侧重于研究用于生产生物制药的核心纯化方法 - 色谱法。具体而言，我们寻求理解这种新型矩阵材料的固定方法，从而允许优化功能吸附材料的制造。这是建立具有新技术的强大纯化平台的重要组成部分，该技术在生产力，终生，进料屏复杂性以及确实有机会促进连续下游操作方面具有重要的运营优势。生物制药是制药行业越来越重要的领域，现在开发的所有药物中有三分之一是生物制药，它们占了十大收入大块的一半。开发一种新药需要10多年和8亿美元。生物制药的属性率很严重，在第1阶段临床试验中只有9％到达市场，而在10种药物中只有3个实际上产生了足够的揭示以弥补开发成本。鉴于开发过程中的高属性率很高，公司可以在早期阶段进行制造资源。潜在的重要制造成本降低，该技术能够通过大量的外部“溢出”收益来减少这种早期燃烧。这里创建的新的生物流程纯化技术将继续使UCL能够在向英国生物工业的制造路线推进工业发展的最前沿的制造路线方面发挥自己的作用。英国的生物加工部门在经济上很重要，目前有480多家公司，拥有26,000名员工，并产生40亿英镑的年度揭晓。这个CRD项目的交付是开发该技术以进行工业实施的关键步骤。该行业必须降低成本，以使生物治疗药更广泛地可用，并增加该地区的研究量。下面列出了与UCL参与此CRD项目有关的关键目标： - 扩大部门和UCL纯化领域的知识和研究活动。 - 通过发表论文来传播这项工作，以产生进一步的研究机会并增加协作。 - 为新技术和筛查平台的工业发展做出贡献。 - 通过MBI培训课程，会议和教学等活动分享知识。 - 引入新的分析技术并开发领先的技术。