Cell-in-a-Box®, allows cells to be implanted in the body and remain protected from immune rejection. The capsules are porous so any biologic made by the cells will be released such as vaccines, cytokines, immunomodulatory molecules, monoclonal antibodies, growth factors, enzymes, stem cell vesicles etc. We have published peer reviewed papers on most of these applications. Moreover, we know from clinical trials in other areas of application of Cell-in-a-Box® that it is safe and efficacious. Importantly, Cell-in-a-Box® encapsulated cells can be produced at our GMP facility and they can be stored at -80c for over 5 years without loss of viability and shipped across the world.
We are the only cell encapsulation company using cellulose sulphate for encapsulation. Our cellulose sulphate is proprietary and patented. All our competitors are using other encapsulation materials (mainly alginate) and are usually focusing on one specific application.
Austrianova offers the Cell-in-a-Box® technology as a platform technology, agnostic of its application. In contrast to other encapsulation technologies, Cell-in-a-Box® allows certain cells to GROW within the capsule, allowing excellent filling of the capsule and thus maximising the number of cells that can be encapsulated. In contrast to other encapsulation technologies, Cell-in-a-Box® encapsulated cells can be stored for many years at -80c and have been shipped around the world on dry ice to various clients. Finally, also in contrast to other encapsulation materials, Cell-in-a-Box® capsules elicit no rejection response from the body’s immune system and thus there is no foreign body response.

Austrianova’s Cleanroom setup is based on the principles of complete isolation. The Product never comes into contact with the operator during GMP oprations since all operations are carried out in a large interlinked chamber isolator.

The isolator, which is situated in a Class D suite, is completely closed and runs on medical grade triple filtered gasses. Items are brought into the islator through pass-boxes in which they undergo a series of air changes to ensure that no particles or contamination is brought into the isolator, which itself works as a Class A environment.

Our islator contains all equipment necessary for cell biology work, including a heated cell work bench, cell culture incubator, recording microscope, centrufuge, bioreactor, encapsulation machine, filling machine. Each of these machines are fully GMP compliant and are situated in their own isolator segment which is physically seperated from other segments. Further, the gases in the isolator can be adjusted to accomodate the requirements of any cell type.

Our isolator and D-room are part of our larger GMP facilitity with all other necessary ancillary rooms and services. We operate to US FDA, EMA, TGA and PIC/s standards.

Our staff are fully trained in all aspects of our GMP operation including our electronic Quality Managment System. The data generated by this German-made system is stored at separate duplicated secured locations in Switzerland to ensure full data safety and protection.

Our isolator GMP set-up allows us to be up and working much faster than conventional cleanroom setups and this equates to cost savings for our customers.