Biologics are medical drugs produced using biotechnology, other than direct extraction from a native biological source. Many biopharmaceutical products are subject to very strict production, storage and distribution requirements in order to preserve effectiveness and safety. Biopharmaceuticals stability is a key issue in assuring that these medicines maintain their quality, safety and full potency.
ExtremoChem proposes novel excipients containing synthetic small organic molecules, from 8 to 12 carbons, called eXtremochem. eXtremochem is able to stabilise proteins and other biological material by preventing their degradation under stressful conditions, such as higher or lower temperatures, pH, salinity, agitation under which they would otherwise degrade. eXtremochem is suitable for Hepatitis B vaccine, Infliximab (chimeric monoclonal antibody) and Erythropoietin (glycoprotein hormone).
The eXtremochem excipients not only increase efficacy, quality and safety of the biologics, but it also bring significant savings to biopharmaceuticals by reducing infrastructure cost by 5-50% depending on the region, cutting off investment for cold chain systems (6-80% of total cost) and increasing production volume by at least 20%. eXtremochem enables simpler biologics transportation and storage conditions, thus making these drugs more accessible in developing countries, was and disaster zones, where there is no reliable cold chain infrastructure. The Phase 1 project will allow ExtremoChem to evaluate the medicines’ degradation under the presence of the small organic molecules through several stabilization tests, prepare a feasible industrial scale-up plan, plan a sound Ph 1 clinical trial, elaborate the business scale up, and size the reachable market and a reliable market share. Within the overall project, ExtremoChem aims to: transfer the excipients production to a CMO, obtain the clinical validation and sign at least one commercial agreement.