Sustainable purification of gene therapy pharmaceuticals

Purpose and goal:

The project´s aim is to validate the benefit of using a new technology for the purification of next-generation bio-based drugs for gene therapy. By using Nyctea´s new patented method for electrochemical purification, we will evaluate the possibility of reducing the use of raw materials for purification, increasing the yield of product, and creating new opportunities for digitalisation and automation of the purification process.

If we succeed, we achieve a more environmentally friendly manufacturing process while reducing the financial costs of producing. Expected results and effects: We expect to prove at early pilot scale that we achieve the following:

1. Replace the use of toxic and problematic chemicals in the purification process that are currently used with conventional purification methods. 2. Reduce the total use of raw materials (including solvents and ultrapure water) by up to 60%.

3. Increase the yield >10% creating incentives for manufacturers to adopt the technology for the improvement of the environment and economic interests. The combined output leads to a more efficient and environmentally friendly purification of next-generation drugs. Approach and implementation:

In close collaboration with project partner AstraZeneca, implement three work packages to create an improved purification process for pharmaceuticals. The first work package is about reducing the use of reagents, water and solvents. The second work package is about, with a reduced amount of raw material, how much can we also increase the yield of the process, the amount of product.

In the third step, we work with preparations for implementation. We are creating a new purification process that can be integrated into the industrial project party´s existing manufacturing processes.