ScaleGla – A scalable manufacture process for MLT-001, a new drug substance for treatment of COPD
| Reference number | |
| Coordinator | MucoLife Therapeutics AB |
| Funding from Vinnova | SEK 1 000 000 |
| Project duration | November 2026 - May 2028 |
| Status | Ongoing |
| Venture | Research infrastructure - utilisation and collaboration |
| Call | Support to small and medium-sized companies for the use of life science infrastructure |
Purpose and goal
The project´s aim is to establish and verify a scalable manufacturing process for MLT-001, MucoLife´s inhaled peptide therapy that dissolves mucus plugs in the airways in COPD. The goal is a process that achieves high purity with documented yield and that can be transferred to GMP manufacturing. The result is a prerequisite for toxicology studies and clinical trials, and for MLT-001 to eventually reach patients who currently lack treatment for mucus plugs.
Expected effects and result
The project is expected to provide a verified, scalable manufacturing process for MLT-001 with a transferable process description and control strategy for future GMP manufacturing. It reduces technical and commercial risk, lowers manufacturing costs and enables toxicology studies and clinical trials. In the long term, MLT-001 could become the first treatment targeting mucus plugs in COPD. The knowledge can also be used for other peptide drugs.
Planned approach and implementation
The project is implemented over 18 months in four work packages: analytical basis and baseline, development of the purification process, integrated process with verification on a larger scale, and transfer package and project management. Three decision points with established criteria guide further work. MucoLife leads the project and decides on continuation.