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.
Bac-in-a-Box®, our related encapsulation technology, can protect probiotics from low pH in the stomach and lead to better re-colonisization of the gastric tract as well as can be freeze dried for easy storage and transport at room temperature without a cool chain and without significant loss of activity. In addition, Bac-in-a-Box® has applications for redressing the microbiome balance and for delivery of oral live bacteria vaccines.
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 or variants thereof).
Austrianova offers the Bac-in-a-Box® technology as a platform technology, agnostic of its application. In contrast to other encapsulation technologies, Bac-in-a-Box® allows bacteria and yeast to GROW within the capsule, allowing excellent filling of the capsule and thus maximising the number of cells that can be encapsulated.
Our Cleanroom and Equipment
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.
Quality Management System
Austrianova is committed to the highest standards of product safety, customer satisfaction, intended performance and regulatory compliance throughout our R&D and GxP manufacturing and services. These fundamental quality standards at Austrianova apply to all employees in every function and operation.
To achieve this level of quality, Austrianova has implemented a comprehensive Quality Management System (QMS).
The policies and principles of the Austrianova QMS are based on GXP principles and are designed to help Austrianova to adopt a systematic approach to quality. Implementation of these procedures ensures that we consistently meet the safety, efficacy and quality requirements expected by international regulatory bodies as well as by our collaborators and customers.
Austrianova is committed to providing quality products through:
- Satisfaction of customers/regulatory agencies
- Building quality, safety and efficacy into the product during development and manufacturing
- Adherence to proven procedures and total commitment to meeting and exceeding customer/regulatory requirements Adherence to proven procedures and total commitment to meeting and exceeding customer/regulatory requirements
- Adherence to proven procedures and total commitment to meeting and exceeding customer/regulatory requirements
- Adequate training of our employees
- Maintaining an organisational structure that fosters continuous improvement
- Integrated risk assessment
- Management involvement and responsibility