Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application
Sublimity has received partial funding to support commercial scale up and manufacturing of ST-0529 through the H2020-SMEINST-2-2014 European Commission program; reference number: 666795. Details of the grant and scale up project are summarized below.
The success of ST-0529 is dependent on positive clinical trial results and the company’s ability to scale up and manufacture stable drug product at a commercial level. This project focuses on achieving product scale-up in the EU, supported by EU-based subject matter experts, local technology and equipment suppliers. In addition to enhancing Sublimity’s intellectual rights and manufacturing know-how, the program provides a stimulus to generate new long-term high-skill jobs and to foster technological innovation in the EU.
Specific Objective of the Project
Complete scale-up of an advanced nanoemulsion-based manufacturing process required to carry out clinical development, with the flexibility to expand manufacturing to accommodate commercial supply demands.
Ulcerative colitis affects 1 million people in Europe, 1.1 million in the US and up to 1 million in the rest of the world. There is a significant need for safe, effective and convenient alternatives to biologics and other systemic therapies, particularly for the moderate-to-severe form of the disease which affects more than 50% of all patients with UC. ST-0529 has potential to be an important treatment advancement for these patients; however, scale-up is recognized as the key bottleneck between the clinical and technical proof of concept and late-stage clinical development, regulatory approval and commercial launch.
Innovative Business Solution
The SmPill® drug delivery platform is a ground-breaking technical innovation that may lead to the development new therapies like ST-0529 to treat diseases of the gastrointestinal tract where unmet clinical needs exist, and the market opportunity is significant.
Expected Outcomes of the Project
The project will increase the number of highly skilled staff employed by Sublimity and is expected to lead to filing of new patents while advancing development of ST-0529, the SmPill® technology platform, and the company’s extended product pipeline.