Al4SAFEMEDS

Project description

AI4SAFEMEDS will develop a computational toolset (degradation prediction software + degradation product database (DB)) from TRL 3 to 6 to support mandatory forced degradation testing of active pharmaceutical ingredients (APIs) and formulated drug product, as well as support formulation activities to improve stability. The computational toolset will be licensed to pharmaceutical industry, CROs, CMOs and analytical companies to be deployed in a "software as a service" model.

Drugs in solid dosage form account for >80% of marketed drugs. Due to the lack of specific testing methods for solid formulations, most mandatory forced degradation testing is performed in solution. ICIQ’s computational toolset will support both current commercial testing (solution) and upcoming mechanochemical approaches (solid phase) which more closely mimic real-life degradation of drugs during storage.

The project will place a strong focus on the prediction of (carcinogenic) nitrosamine degradation products. There is a tremendous need and pain point for pharma
customers starting mid-2018 resulting in several product recalls (including in 2022 by Pfizer and Novartis) and ensuing drug shortages of highly needed medicines (blood pressure, heart disease, diabestes, oesophagal reflux disease and many more). Currently, a proper nitrosamine risk assessment is mandatory for all marketed and new medicines. Available testing and software options are often failing to predict and find the root cause of nitrosamine formation.