GMP compliant manufacturing of allogenic stem cells such as MSCs is available at highly competitive prices
GMP compliant manufacturing of allogenic stem cells such as MSCs is available at highly competitive prices

Stem Cell Manufacturing 

Austrianova offers a standardised cell therapy that can be used for all patients without requiring use of the patient’s own cells. This is called allogenic therapy. It can be used for treating diseases as diverse as Graft versus Host disease, various types of cancer and for infectious diseases. 

 Why Stem Cell Manufacturing with Austrianova?

 

Till now most of these treatments using human cells involve the harvesting of the patient’s own cells, selecting or modifying those cells in the laboratory, and then returning the cells to the patient to give a therapeutic benefit. This is called autologous therapy which is personalized, labour intensive and costly. 
We are offering the manufacturing of a standardised cell therapy that can be used for all patients without requiring use of the patient’s own cells. This is called allogenic therapy. It can be used for treating diseases as diverse as Graft versus Host disease, various types of cancer and for infectious diseases. 
There is an increasing interest in the use of allogenic cells which can be manufactured cheaply and used for an expanded repertoire of patients. The technology and equipment needed for the large scale production of allogenic cell therapies is different to that needed for small scale personalized autologous products. Further the testing requirements for allogenic products that are classified as medical products, differ from those of autologous cell therapies which are seen as treatments. Thus, with our expertise and background in the production of cell based “Cell-in-a-Box” allogenic cell products, we are ideally placed to manufacture allogenic MSCs.

Many of our potential customers already have an established client base and are offering autologous cell therapies to those customers on an individualised medicine basis. Their business model is completely different. In their business model they will harvest cells from their patients, select or modify them individually and then introduce those cells back into the same patient. This is a small scale, high cost and highly personalised service, which cannot be utilised for all potential customers because of either cost reasons, or patient health reasons precluding the harvesting fo their cells.

In contrast, we will take pre-qualified and tested cells and grow up large batches that can be rigorously tested and then used to treat any patient. This increases availiability and reduces cost. We will then sell the manufactured allogenic cells to our potential customers. Our potential customers see this as an addition to their existing product portfolio that will allow them to expand their market reach.

Currently there are four clinical trials in the USA that are testing such allogenic therapy for the treatment of COVID-19. Celularity (www.celularity.com) is using cryopreserved, off-the-shelf, allogenic NK cells derived from placenta (CYNK-001), whilst Mesoblast (www.mesoblast.com) is using its allogenic mesenchymal stem cell (MSC) product (remestemcel-L). Pluristem (www.pluristem.com) is using their allogenic placenta derived PLX cells. Athersys (www.athersys.com) is using their MultiStem allogenic MSC product to treat acute respiratory distress syndrome in COVID-19.