13TSB_TIBio: Technology Inspired Innovation Bioscience - Puridify

我们在UCL和SME Purify的领先学术团体之间的这个合作项目为一个高度集中的项目提供了机会，该项目具有高水平的专业知识，可以开展下述技术创新工作，旨在解决生物制药工业生产过程中的既定纯化挑战。UCL和Purify在这项活动中得到了三个工业合作伙伴的支持，这些合作伙伴被选中为分析和制造方面提供支持（在各自领域处于领先地位），并提供将研究结果转化为实践的途径。这里描述的研究合作重点是研究用于生物制药生产的核心纯化方法-色谱法的性能。具体而言，我们寻求理解这种新型基质材料的固定化方法，从而允许功能性吸附剂材料的优化制造。这是建立一个强大的纯化平台的一个重要组成部分，该平台采用了一种新技术，在生产率、使用寿命、进料流复杂性以及促进连续下游操作的机会方面提供了显着的操作优势。生物制药是制药行业越来越重要的一个部门，目前正在开发的所有药物中有三分之一以上是生物制药，它们占前十大收入大片的一半。开发一种新药需要10年时间和8亿美元。生物制药的流失率非常严重，在第一阶段临床试验中只有9%的药物进入市场，并且只有十分之三的药物实际产生足够的收入来收回开发成本。鉴于开发期间的高损耗率，公司不愿意在早期阶段投入制造资源。这项技术能够显著降低制造成本，从而减少早期负担，并带来显著的外部“溢出”效益。这里创造的新的生物工艺纯化技术将继续使UCL在推进英国生物工业的制造路线方面发挥作用，同时保持研究处于工业发展的最前沿。英国生物加工行业在经济上非常重要，目前有480多家公司，雇用26，000人，年收入40亿英镑。该CRD项目的交付成果是开发该技术用于工业实施的关键一步。该行业必须降低成本，使生物治疗更广泛地提供，并增加该领域的研究量。与UCL参与该CRD项目有关的主要目标如下：-在部门和UCL内扩大净化领域的知识和研究活动。- 通过发表论文传播这项工作，以创造进一步的研究机会和增加合作。- 为新技术和筛选平台的工业重点开发做出贡献。- 通过MBI培训课程、会议和教学等活动分享知识。- 引进新的分析技术，开发领先技术。

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.