ADVANCED CELL THERAPY CENTRE

Advanced cellular therapies hold great promise for the future and they offer hope for many incurable diseases.

Advanced Therapy Medicinal Products (ATMPs), comprising ex vivo expanded somatic cell therapy products and tissue-engineered products, are at the forefront of innovation. The medical and business opportunities provided by these products are considerable.

However, major regulatory and quality issues need to be resolved for the manufacture of ATMPs. These products are highly heterogeneous owing to their origin, starting material, degree of manipulation, and manufacturing process.

We are establishing an Advanced Cell Therapy Centre to develop novel cell production processes and new product testing methods to meet the challenges of national and EU requirements covering ATMPs.

The facility will house cleanroom space, allowing GMP level production of cellular therapy products, as well as a cell culture laboratory for cell product testing and process development.

The facility:

• allows manufacture of consistent autologous or allogeneic products to a predefined quality
• offers rigorous control of the manufacturing process and specifications
• allows us to perform*:
  - minimal manipulations such as selection of purified cell
    populations 
  - substantial in vitro cell manipulations involving cell engineering 
    long-term ex vivo expansion and culture of cells
• allows us to produce*:
  - somatic cell therapy medicinal products
  - tissue-engineered products  
  - combined advanced therapy medicinal products containing e.g.
     medical devices
• is optimal for small to medium-scale cell production (up to 109 cells)
• offers a flexible and adaptable cleanroom solution
• allows us to produce cellular therapy products for clinical trials, but also serve as platform for either distribution or manufacture of products that have market authorization
• offers scientific and quality expertise to enable rapid translation from research into a GMP-compliant production process
• provides possibility for contract process development for cellular therapy products within the GMP facility.
  

"We are building a novel clean room solution, which will reduce the contamination risks and thus increase the patient safety."
Dr. Johanna Nystedt, Manager, Advanced Cell Therapy Centre