Antibody medicines that currently require constant freezing from factory to patient will be turned into shelf-stable liquids that can be stored at room temperature. This matters because antibody drugs—used to treat cancer, autoimmune diseases, and infections—are notoriously fragile. Their molecules clump together (aggregate) unless kept at ultra-cold temperatures around -80°C throughout production, transport, and storage. Cold-chain failures cost the biopharmaceutical industry $35 billion annually, and the infrastructure is scarce in low- and middle-income countries, limiting access to these treatments. The project uses a proprietary technology called Ensilication, which coats antibody molecules to prevent aggregation, eliminating the need for cold storage. If successful, the technology could transform the manufacturing and supply chain for antibody therapies. It would cut product losses and cold-chain costs, and allow reformulation into smaller, more concentrated doses. That shift would enable subcutaneous injections at home or in community clinics instead of lengthy intravenous infusions in hospitals. The process is designed as a platform applicable to other biopharmaceuticals, and the intellectual property will be licensed to manufacturers for global distribution.
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Currently antibody medicines require ultra-cold-chain during production and storage to prevent spoiling due to aggregation at the molecular level, which can occur at any stage from factory to patient. This project uses game-changing, proprietary Ensilication technology to remove this cold-chain dependence in the manufacturing and supply of antibody treatments. Ensilication technology will: * reduce product losses during manufacturing, * eliminate cold-chain costs and wastages during transport and storage. Additionally, there are potential patient benefits as ensilication supports antibody therapies to be reformulated for lower volume/higher concentration, allowing a move from intravenous to subcutaneous administration in the community/home rather than clinic settings. EnsiliTech and CPI will demonstrate the implementation of the Ensilication process for antibody production and will perform comprehensive analysis and comparison of COGS with ensilication addition. **Cold-chain logistics for antibody transport and storage** Most antibodies require cold-chain logistics, with most therapeutic antibodies needing ultra-cold storage (-80°C) due to their aggregation propensity. Cold-chain failures are expensive, costing the biopharmaceutical industry $35 billion annually. Cold-chain infrastructure is also challenging in low and middle-income countries (LMICs) making antibody treatments less accessible. **Antibody aggregation and easier subcutaneous administration** Antibodies are prone to aggregation, resulting in low product concentration and frozen storage. Most are administered intravenously in hospitals, inconveniencing patient experience with long injection times. Ensilication prevents antibody aggregation and allows for increased concentration in smaller volumes, which can enable reformulation for subcutaneous administration. This technology enhances ease of administration by reducing the physical volume of antibody treatments, removing aggregation and allowing for room-temperature stability. The project leverages the growing trend of reformulating intravenous antibody treatments for **subcutaneous administration**, which is less invasive, more convenient, and can be administered in community or home settings. **Impact of the Project** **Sustainability and Accessibility**: By removing the dependency on cold-chain logistics and improving antibody stability and administration, the project will significantly reduce costs and improve treatment access, especially in LMICs. **Scalability**: The manufacturing process developed for ensilicated antibodies is applicable to other products, creating a platform for the production of thermally-stable antibody therapies and other biopharmaceuticals. **Healthcare and Ecological Benefits**: The project reduces the environmental and economic burden of cold-chain logistics and hospital-based administration while improving patient access to advanced antibody therapies. Moving treatments to community settings will also alleviate pressure on healthcare systems. The intellectual property generated will be licensed to manufacturers, enabling sustainable production and broader distribution of antibody therapies across the globe.
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