Collaboration process development of dual chamber drug container for biologic drugs
|Coordinator||ILYA PHARMA AB|
|Funding from Vinnova||SEK 1 000 000|
|Project duration||December 2017 - June 2018|
Purpose and goal
The aim with this project was to start collaboration in process development where the drug candidate developed by Ilya Pharma is produced directly into a 2 two compartment syringe and how this could be integrated in the manufacturing process. The objectives were met and the data generated can be implemented in the drug development documentation ultimately shortening time to market approval.
Expected results and effects
Collaboration agreements with the two partnering companies were met and compatibility of the drug substance and the two compartment syringe was validated and a method for integration of filling the drug substance directly into the two compartment syringe was developed and ultimately tested with satisfactory results.
Planned approach and implementation
The projektet was managed by Ilya Pharma and was conducted as described in the project plan and different work packages. This project is a parallell RnD project to the whole drug development project and the results from this project are integrated in the documentation required. The process will be further developed and finally used in producing the material to the phase II clinical study.