ATMP Manufacture

Vecura - An Infrastructure for Development and Manufacturing of ATMPs.

Lead: Karolinska University Hospital – Pontus Blomberg

Involved partners: Karolinska Institutet, Uppsala University, Cell Seed, GE Healthcare, RISE

The project aims at facilitating the translation step into the clinic by providing access to GMP manufacturing capabilities and associated expertise

Examples of tasks and actions:

– GMP adaptation of manufacturing processes
– Validation of processes and QC analyses
– GMP manufacturing of ATMPs

Interview with project leader

Hi Pontus Blomberg!

What is the need your project addresses?

Manufacturing of ATMPs for clinical trials has to be GMP compliant which requires specialized licensed infrastructures. However, GMP manufacturing capability is very costly to establish and operate.  The project provides CAMP partners access to the Vecura GMP facility and provides support in the development towards validated GMP compliant manufacturing processes established at a national facility.

What is your approach to meet the need

The approach is that we will work closely with CAMP partners trying to develop new products and treatments by offering our long experience in GMP and how to take investigational products to the clinic.

How will this improve Sweden´s capabilities within ATMPs?

By providing access to already existing GMP manufacturing capabilities the transition from pre-clinical work into clinical studies will be accelerated.

For more information please contact Pontus Blomberg