Design, build and process analytics control (PAT) of GMP equipment and process for continuous manufacture of long acting, controlled release drugs.

本项目旨在将生产控释注射药物的批量工艺转变为具有适当控制机制的连续工艺，以确保使用符合FDA和其他监管机构要求的方法生产稳健、一致的产品。这是以前从未实现过的。对于病人的护理和治疗来说，缓释药物疗法以可控和可预测的释放率释放其有效成分尤为重要。实现药物微球的精确控制需要在制造过程中对粒度和粒度分布进行良好的控制。Micropore将与韩国的G2GBIO公司合作开展该项目。两家公司自2019年以来一直有合作历史。在此期间，G2G BIO将现有的阿尔茨海默病药物重新用作长效注射药物，以提高患者的依从性。Micropore以其先进的横流技术支持G2GBIO。G2GBIO的产品已在加拿大获得i期临床试验批准。开发的下一步是将制造过程转化为能够通过监管审查的大批量连续过程。从历史上看，乳化生产供应链很难实现规模经济。标准制造技术使用强力转子/定子均质技术，这种技术提供局部高剪切力，破坏产品质量，并导致乳液液滴尺寸分布广泛。这需要昂贵的分离过程，以产生较小尺寸范围的最终产品，并造成严重的浪费（通常为30%以上，但Micropore有几个例子高达90%的浪费）不合规格的材料。最近，Micropore的技术已经证明了其温和的工艺技术几乎零浪费的能力。在这3年的时间里，Micropore Technologies和G2GBio提议将Micropore的横流技术从单膜单元扩展到多膜单元，以提供更具成本效益的强大制造路线，满足G2GBio对多公斤制造的已知要求。除此之外，Micropore和G2GBio还将合作确定内联过程分析，以使FDA和其他监管机构的质量设计（QbD）和过程分析技术（PAT）的原则能够提供具有强大过程控制的集成过程。Micropore凭借其核心技术赢得了多个全球奖项，并在全球范围内获得了市场吸引力。

This project aims to transform a batch process for the manufacture of controlled release injectable drugs into a continuous process with appropriate control mechanisms to ensure robust, consistent product using methods that comply with FDA and other regulators' requirements. This has never been achieved before.It is particularly important for patient care and their treatments that sustained release drug therapies deliver their active components at a controlled and predictable release rate. Achieving this precise control of drug microspheres requires good control over particle size and size distribution during the manufacturing process.Micropore will partner with G2GBIO INC of South Korea in the project. The two companies have a history of collaboration since 2019\. During this time G2G BIO has repurposed an existing Alzheimer's drug as a long acting injectable to improve patient compliance. Micropore has supported G2GBIO with its advanced crossflow technology. G2GBIO has achieved Phase 1 clinical trial approval in Canada for their product. The next step in development is to convert the manufacturing process into a high volume continuous process that will pass regulatory scrutiny.Historically, it has been difficult to achieve economies of scale in the emulsification production supply chain. Standard manufacturing technology uses brute force rotor/stator homogenisation techniques, which provide localised high shear forces, damaging product quality, and resulting in a broad emulsion droplet size distribution. This requires costly separation processes to produce a narrower size range final product and creates significant wastage (Typically 30%+ but Micropore has a few examples of up to 90% wastage) of out-of-specification material. More recently Micropore's technology has demonstrated a near-zero waste capability arising from its gentle process technology. In this 3 year Micropore Technologies and G2GBio propose to scale up Micropore's crossflow technology from a single-membrane unit to multiple-membrane units to provide a significantly more cost-effective robust manufacturing route, meeting G2GBio's known requirements for multi-kilogramme manufacturing.In addition to this Micropore and G2GBio will collaborate to identify inline process analytics to enable the principles of the FDA, and other regulators, of Quality by Design (QbD) and Process Analytical Technology (PAT) to deliver an integrated process with robust process control.Micropore has won a number of global awards for its core technology and has gained market traction across the world.