Verification of container for developed innovative drug substance
|Coordinator||ILYA PHARMA AB|
|Funding from Vinnova||SEK 300 000|
|Project duration||March 2017 - July 2017|
|Call||Innovativa startups fas 1 Våren 2017|
Purpose and goal
The aim of the project was to verify compatibility of a two chamber syringe in the manufacturing process of Ilya Pharma mening the shape of the container is changed. The goal was to find a supplier of syringes with where regulatory or legal aspects fitted with the manfacturing process in Ilya Pharma and to run pilot tests.
Expected results and effects
Suppliers were evaluated and two possible alternatives were identified, the products tested and an assessment of the regulatory framework applying was performed. The project in Innovative startups was run in parallell with other projects of process development in manufacturing together leading to major achievements in the drug development program of Ilya Pharma.
Planned approach and implementation
A senior expert on manufacturing of biological drugs was contracted to the project and pilot tests were performed by subcontractors. The analysis of the material is performed by Ilya Pharma.