Development of a Scalable Manufacturing Process for a Novel Oral Infliximab Product using the Soteria Technology

Though the monoclonal antibody (mAb), infliximab, is considered a gold-standard treatment for the 300,000 patients in the UK with inflammatory bowel disease (IBD), the compound can only be administered through an inconvenient and often painful injection. In doing so, only less than 1% of the drug reaches the site of disease, limiting the efficacy of the treatment whilst causing a wide range of serious side-effects. Intract Pharma's novel drug delivery technology, Soteria, allows for infliximab to be administered orally, creating a more targeted IBD treatment. In partnership with the Centre for Process Innovation (CPI), Quay Pharmaceuticals and Pharmidex, Intract Pharma will develop, optimise and validate a manufacturing process that enables mAbs to be formulated as an oral solid dosage form, and in turn create a GMP-ready manufacturing protocol for Soteria. So far, mAb therapies have not yet been able to be manufactured for oral administration in both a clinically and commercially viable manner. Therefore, the project will develop new innovative manufacturing approaches in the field of pharmaceutical formulation, particularly with regards to antibody stabilisation and formulation. As a result, this project will not only break new ground in antibody formulation but further develop a therapeutic that could vastly improve the treatment of patients with IBD.