Karolinska Cell Therapy Center (KCC) is a core facility whose function is to facilitate the development of new treatments with advanced therapy drugs (ATMP) and cells for transplant. Pontus Blomberg, operations manager at KCC, tells us more!
Pontus Blomberg. Photo: Mia Orling/Fotograf Medicinsk Bild.
What is the KCC, what is Vecura, and how are they connected?
“KCC is a business within Research, Education and Innovation Support (FoUUI) at Karolinska University Hospital in Huddinge that supports clinics and researchers in academia, healthcare and industry who want to develop therapies based on cells, tissues and drugs for advanced therapy (ATMP). KCC is a single entry point for guidance and evaluation of projects that intend to use Karolinska University Hospital resources. Vecura is the production unit that produces ATMP for clinical trials in accordance with Good Manufacturing Practice (GMP), i.e., the minimum standard that a pharmaceutical manufacturer must meet in its production processes.”
What does “Single entry point” mean?
“Via KCC’s Single Entry point, researchers, clinics and industrial companies receive guidance about the process from research product to quality-assured product for clinical trials or treatment in hospital exemption. This also facilitates contact with relevant people within Karolinska.”
How unique is this service? Are there any other manufacturing units for ATMPs in Sweden or other Nordic countries?
“In Europe, there are currently a small number of ATMP manufacturing units in a hospital environment, and several are under construction.”
Can you tell us about an exciting project that you’ve dealt with?
“Together with the University Hospital in Uppsala, Uppsala University and Baylor College of Medicine in Texas, we were the first facility in Europe to establish CAR T cells for clinical trials. More than 40 patients with B-cell malignancies have been treated at Uppsala.”
Can companies approach you for support? What kind of help can you give companies?
“Companies are welcome to contact us if they plan to manufacture an ATMP for clinical trials. First, we decide whether we can take on the project and then, together with the company, we establish a timeline and a cost estimate. It is also possible to contact KCC with more general questions about drug development in the ATMP field. We are also able to recommend potential partners within Karolinska University Hospital and Karolinska Institutet.”
Is there anything companies should think about before contacting you?
“That depends entirely on what phase a company is in. If you’re planning to start GMP production, you have to have a manufacturing process in place that is at the right scale and that results in a product that meets the desired specifications. If you don’t have that, we recommend you contact the Pre-GMP laboratory at KI that will be able to provide support on process development.”
What types of projects come to you?
“It’s a mixture of early and late phase projects, with participants from different areas.”
You are part of the Stockholm Life Tech project that is financed by the European Structural and Investment Funds – how do you hope to benefit from that?
“We hope that the Stockholm Life Tech project will make it easier and more efficient for us to start collaborations with external customers.”