International Institute for Advanced Pharmaceutical Manufacturing (I2APM)

EPSRC连续制造和结晶创新制造中心致力于在开发新的连续制造技术方面建立新的合作，以提高对颗粒形成的理解，并利用这些知识来提高具有特定有益特性的颗粒的制造。鉴于微粒加工在许多精细化工行业中的重要性，包括农用化学品、制药、染料、颜料和含能材料，这具有巨大的潜力。我们建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，创建国际先进制药制造研究所，目标是促进医药产品一次和二次一体化连续制造的科学和技术。该项目的目的是确定映射到共同感兴趣领域的具体活动，并开始就向前交流达成一致，与业界接触，并为联合会议、研究人员和教师交流、合作研究和培训活动制定具体计划，这些活动将使两个合作国家的更广泛社区受益。此外，将通过与英国/欧盟和美国监管机构以及行业共同努力，制定模拟提交的范围，即批准新药使用的监管程序，以就框架达成一致，以确保学术贡献在应对采用连续生产的监管挑战方面的影响。拟议的与国际专家的联系将加快将连续制造工艺整合到高价值化工部门的进展，提高英国研究的知名度，并最终增加高质量、协作研究成果的机会。

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.