Vecura - An Infrastructure for Development and Manufacturing of ATMPs.
Lead: Karolinska University Hospital – Pontus Blomberg
Involved partners: Karolinska Institutet, Uppsala University, Cell Seed, Cytiva AB, RISE
”Complete and long-lasting clinical responses in immune checkpoint inhibitor-resistant, metastasized melanoma treated with adoptive T cell transfer combined with DC vaccination.” see project page
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”Karolinska Institutet Human Embryonic Stem Cell Bank.” see project page
”Complete Remission with Reduction of High-Risk Clones following Haploidentical NK-Cell Therapy against MDS and AML.” https://pubmed.ncbi.nlm.nih.gov/29444931/
”Gene therapy – from idea to reality” (Swedish) https://pubmed.ncbi.nlm.nih.gov/29297925/
”A Phase I/IIa Trial Using CD19-Targeted Third-Generation CAR T Cells for Lymphoma and Leukemia.” https://pubmed.ncbi.nlm.nih.gov/30097433/
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