Vesicles for RNA delivery

Lead: Karolinska Institutet – Alamdar Hussain

Involved partners: Vecura, Karolinska University Hospital, Vycellix, CellProtect, AstraZeneca

The project aims at developing large scale production of Extracellular Vesicles (EVs) under Pre-GMP conditions. EVs are membrane bound vesicles released from the cells with cargo consisting of proteins, lipids and nucleic acids. EVs are being used as vehicles for drug delivery. Drugs (proteins or RNA) loaded in or on the EVs are protected from degradation and can be specifically delivered to the target cells and tissues. In this project, we will optimise large scale production, isolation, purification, storage and delivery of EVs following Pre-GMP conditions. This project will provide the foundations required for the large-scale GMP production of EVs.

Examples of tasks and actions:

1. Stable cell lines for the production of EVs

2. Large scale cell culture and its optimization for EVs secretion

3. Large scale EVs isolation, purification and characterization of EVs

4. Storage and delivery optimization

Interview with project leader

Hi Alamdar Hussain!

What is the need your project addresses?

Extracellular Vesicles are an important vehicle for drug delivery. Large scale pre-GMP production and optimization has not been carried out for this novel drug delivery method. This project will allow the process development of large scale EVs production for medical use.

What is your approach to meet the need?

We will produce EVs in the Pre-GMP facility following the conditions and criteria required for ATMPs production. This will make it easy to transfer the process from Pre-GMP to GMP facility for production.

How will this improve Sweden´s capabilities within ATMPs?

ATMPs production is a challenge and needs enormous amount of “Man, In-kind and Time” resources. This project will build up Sweden’s capacity to take EVs projects from lab to “Large-scale GMP” production.

For more information please contact Alamdar Hussain