“The complexity of cells that affords great therapeutic promise also increases the complexity of their manufacture and testing.”
The manufacturing process of Neural DrSC® is a fully automated process and will allow for a large scale production of therapeutic regenerative medicine products to answer patient needs. Quality assurance and quality control are critical factors in the success of our therapies. We are therefore focusing on integrating a scalable and cost effective cell manufacturing process, along with testing, storage and distribution.
The “holy grail” for CNS repair resides in the ability to manufacture :
- Autologous neuronal stem / precursor cells;
- That possess a high level of potency to fix CNS damage; and
- An ability to produce such cells quickly at a cost and scale that can meet the requirements for sound treatment of larger patient groups.
Fortuna Fix has successfully addressed all of these bottlenecks with the Neural DrSC® technology, and has in addition developed the world’s first fully automated end-to-end manufacturing system for the production of virtually unlimited patient-specific batches of Neural DrSC®. This allows automated manufacturing and Quality Control (QC) of autologous cells at a competitive cost and at a virtually unlimited scale (easy and rapid scalability allowing low overhead costs).