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

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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.