Kommersielt attraktiv GMP-produksjon av en biologisk legemiddelkandidat, del#2

Offentlig prosjektsammendrag

This project is a continuation of the R&D work on Tribune Therapeutics' drug candidate TRX-44, aimed at fibrotic diseases. The main goal for 2025-2027 is to complete critical development activities to establish a robust, scalable, and commercially attractive production process for TRX-44, in line with regulatory requirements. R&D challenges include generation and characterization of the master cell bank, upstream and downstream production processes, development and validation of analytical methods, formulation for high concentration and stability, and adherence to GMP ("Good Manufacturing Practice") regulations. GMP compliant drug product is a necessity for starting human trials in most regulatory jurisdictions (e.g. EU and US). The project will utilize systematic experimental methods to solve these challenges and generate GMP drug product ready for use in human trials.