Cell Manufacturing

GMP-certified process

The allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) products are allogeneic, cryopreserved, ready-to-use advanced therapy medicinal products, isolated from lipoaspirate obtained from thoroughly screened healthy adult donors. The entire manufacturing process is conducted in accordance with current Good Manufacturing Practice (GMP) guidelines and relevant regulatory requirements, ensuring a high standard of safety, consistency, and product quality.

Our manufacturing processes have been founded over many years of pioneering research and clinical translation at Rigshospitalet University Hospital, Copenhagen, Denmark. This scientific foundation ensures that our cell therapies are developed with a strong emphasis on quality, safety, and clinical relevance. The ASC products are culture expanded in an animal component-free environment, which eliminates the risk of animal-derived contaminants and enhances the safety profile of the final product. 

The manufacturing process is based on a robust and innovative automated closed bioreactor technology platform, which supports consistent and out-scalable cell production under strictly controlled conditions. This advanced platform allows for monitoring of culture parameters and ensures reproducible quality across different production batches. Moreover, this minimises manual handling and contamination risk while maintaining cell viability and therapeutic potency.

The technology used enables efficient out-scaling, making it suitable for both small-scale clinical studies and large-scale commercial manufacturing.

Several dosages and product formulations are being manufactured to accommodate a variety of therapeutic indications, supporting personalised and disease-targeted treatment strategies.

Stem cells for multiple purposes

We provide GMP-grade and research-grade allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs), tailored for use in both clinical trials and preclinical research. 

Our product portfolio includes customised ASC cell product dosages, designed to meet the specific needs of our collaborators and partners in the life sciences and medical fields.

Our manufacturing is GMP certified, and we are proud to supply clinical trial centres worldwide.