International Institute for Advanced Pharmaceutical Manufacturing (I2APM)

国际先进药物制造研究所 (I2APM)

• 批准号: EP/M021661/1
• 负责人: Blair Johnston
• 金额: $ 31.62万
• 依托单位: University of Strathclyde
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2015
• 资助国家: 英国
• 起止时间: 2015 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=EP%2FM021661%2F1
• 关键词: International; Institute; Advanced; Pharmaceutical; Manufacturing

The EPSRC Centre for Innovative Manufacturing for Continuous Manufacturing and Crystallisation is concerned with establishing new collaborations on the development of novel continuous manufacturing technologies to improve understanding of particle formation and to exploit this knowledge to enhance the manufacture of particles with specific beneficial properties. This has significant potential given the importance of particulate processing across many fine chemical industries including agrochemicals, pharmaceuticals, dyes, pigments and energetic materials.In partnership with the US-based National Science Foundation Engineering Research Center for Structured Organic Particulate Systems, we propose to create the International Institute for Advanced Pharmaceutical Manufacturing with the goal of advancing the science and technology of integrated primary and secondary continuous manufacturing of pharmaceutical products. The aims of this project are to identify specific activities mapped onto the areas of mutual interest and start to agree forward exchanges, engage with industry and develop specific plans for joint meetings, researcher and faculty exchanges, collaborative research, and training activities that will benefit the wider community in both collaborating countries. In addition, the scope of a Mock Submission, the regulatory process by which new drugs are approved for use, will be developed by engaging jointly with UK/EU and US regulators and industry to agree on the framework that would ensure the impact of academic contributions on addressing the regulatory challenges for the adoption of continuous manufacturing. The proposed links with international experts will lead to accelerated progress of integrating continuous manufacturing processes into the high value chemical sector, raise profile of UK-based research, and ultimately enhance the opportunities for high quality, collaborative research outcomes.

EPSRC连续制造和结晶创新制造中心致力于在新型连续制造技术的开发上建立新的合作，以提高对颗粒形成的理解，并利用这些知识来增强具有特定有益特性的颗粒的制造。鉴于微粒处理在许多精细化工行业（包括农用化学品、制药、染料、颜料和高能材料）中的重要性，这一技术具有巨大的潜力。我们提议与美国国家科学基金会结构化有机微粒系统工程研究中心合作，创建国际先进药物制造研究所，目标是推进医药产品一级和二级连续制造集成的科学和技术。该项目的目的是确定双方共同感兴趣的领域的具体活动，并开始商定未来的交流，与工业界接触，并制定联合会议，研究人员和教师交流，合作研究和培训活动的具体计划，这将使双方合作国家的更广泛的社区受益。此外，模拟提交的范围，即新药批准使用的监管过程，将通过与英国/欧盟和美国监管机构和行业共同合作，就框架达成一致，以确保学术贡献对解决采用连续制造的监管挑战的影响。与国际专家的拟议联系将加速将连续制造过程整合到高价值化学部门的进程，提高英国研究的知名度，并最终增加高质量合作研究成果的机会。