Soteria: Revolutionising treatment of inflammatory bowel disease

The Challenge

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal (GI) tract, which leads to the long-term impairment of GI tract structure and function. Crohn’s disease and ulcerative colitis are two of the main IBDs, in which the immune system attacks the body, causing severe flare-ups. Although there is no cure for IBD, it can be managed with monoclonal antibody (mAb) therapies, such as the currently approved infliximab, which can help keep the immune system at bay.

Led by Intract Pharma, CPI collaborated with SGS Quay Pharma and Pharmidex, forming a consortium to develop the first oral formulation of infliximab. The challenge was to develop a capsule prototype, assess and optimise the processing parameters for large-scale manufacture of the product in preparation for a first-in-human clinical trial.

Thanks to the expertise in drug development and manufacture brought by the colleagues from Quay, CPI and Pharmidex, we successfully developed a scalable manufacturing process for oral antibody products.

Silvia Matiz, Formulation Scientist – Intract Pharma

 

How CPI helped

• Definition of quality target product profile.
• Capsule core formulation definition and optimisation.
• Small-scale development and optimisation of manufacturing process in preparation for scale-up.
• Qualitative and quantitative analytical method development.
• Stability testing on final product.

Achievements

• Determined processing parameters for successful large-scale manufacture of oral infliximab capsule product.
• Characterised infliximab in the final drug product.
• Assessed stability of infliximab in final drug product under ICH accelerated conditions and determined shelf life of the product.
• Gave Intract Pharma the proof-of-concept to take the oral infliximab product to clinical trials.

https://www.uk-cpi.com/case-studies/revolutionising-ibd-treatment