Responsible Regional Contact Point
Organisation:	AWSG - AUSTRIA
Contact person:	Behnoosh Amirimani
Contact details:	b.amirimani@awsg.at +43 1 501 75 - 552
Organisation Details
Founded (Year):	2001
No of employees:	11-50
Turnover (US $):	< 1m
Organisation Type:	Company
Company (Organisation) details
The company is a specialist in the research, development and commercialisation of proprietary drug delivery technologies for health care applications. The company has a unique IP protected GMP production line for the encapsulation of living cells in cellulose sulphate. Company’s reference product is the first encapsulated cell product targeting difficult to treat solid tumours. It is now entering pivotal phase III trials in pancreatic cancer, and has received Orphan Drug Designation from the EMEA.
Areas of activity:
-  Medicine, Human Health -  Veterinary, Animal Health -  Biology/Biotechnology -  Generic Tools
1) Technology Offer
GMP production line for the encapsulation of living cells in cellulose sulphate
ABSTRACT: The company has developed a unique and versatile cell encapsulation technology that can be applied to a wide range of therapeutic applications. The company is the only company that has established a cGMP production facility allowing consistent and quality controlled encapsulation of living cells for clinical applications at an industrial scale using cellulose sulphate. DESCRIPTION: 1. Background The company has developed a unique and versatile cell encapsulation technology that can be applied to a wide range of therapeutic applications. The company is the only company that has established a cGMP production facility allowing consistent and quality controlled encapsulation of living cells for clinical applications at an industrial scale using cellulose sulphate. The company’s encapsulation technology ensures the reproducible production of a therapeutic product from defined components. 2. Description of product / process The Company’s GMP manufacturing plant has a capacity of 3000 vials per campaign and 10 campaigns per year, sufficient to meet the projected demand for its lead product. The ability to meet European market demand is a precondition for EMEA market authorisation based on the upcoming phase III clinical trial data. The production of such an allogeneic (one product for all patients) cell based therapy is the first of its kind worldwide. 3. What does the product or process do? The use of cell encapsulation is a technological concept with an enormous clinical potential for the treatment of a wide range of diseases. The principle is to develop an artificial, semi-permeable capsule with sufficient permeability that nutrients and oxygen can reach the transplanted cells, and appropriate cellular products can be released into the bloodstream or to adjacent tissues. At the same time, the capsular material must be restrictive enough to exclude immune cells and antibodies that would cause rejection and destroy the implant. The encapsulated product can thus be viewed as a device that allows transplantation without the need for immunosuppression. A wide range of cells and cell lines (allogeneic or xenogeneic, primary established or genetically modified) may be enclosed within semi-permeable and biocompatible immobilization polymer materials. Although encapsulation technology has long been proposed as the basis of therapies for a wide range of diseases, the field has been thwarted in its clinical development due to a lack of standardized technology and clinically proven materials for membrane manufacturing produced in reproducible batches as well as the added difficulty of scaling up technologies to produce materials in sufficient quantities to permit duplicate studies. Advancing into pivotal clinical trials, the Company has been able to overcome these obstacles, thus placing the company in a unique and competitive position. 4. How does the product or process work? A scheme of the production of the product is available on request on a strictly confidential basis. In principle cells and cellulose sulphate are mixed together and pass through a nozzle to form droplets that are allowed to fall into a polymerisation bath. The droplets rapidly harden from the outside inwards to form capsules containing cells which are then washed and, after a maturation step, filled into glass vials, frozen and then stored at -80°C. 5. What are the applications of the product or process? The company’s encapsulation technology can be broadly applied for development of treatments of a number of diseases outside its oncology focus including chronic or genetic diseases (Diabetes, Parkinson’s disease, haemophilia A and B, peripheral artery disease). The technology can also be applied in immunotherapy and biomolecule augmentation. 7. Quantify claims if possible The company’s encapsulation technology ensures the reproducible production of a therapeutic product from defined components and this exclusive know-how enjoys multilayer IP protection. INNOVATIVE ASPECTS: The company has developed a procedure for the consistent and quality assured manufacture of cellulose sulphate which is the basis for consistent encapsulation. From a commercial perspective this is a highly valuable development since until now the development of products based on encapsulated cells was not possible due to the inability to produce the final product in a large scale to a consistent standard. The company is the first company worldwide that has overcome this obstacle by developing a GMP compliant industrial production process and by setting up a complete manufacturing plant for encapsulation in cellulose sulphate. Both process and plant are under full control of The company. MAIN ADVANTADGES / BENEFITS: The company’s cGMP compliant manufacturing assets, together with its enormous encapsulation know-how and the first encapsulated product being close to a phase III clinical study, open options for the application of the company’s unique encapsulation technology platform to many different areas outside of the oncology focus of the company. Advancing into pivotal clinical trials, the company is in a unique and competitive position. TECHNICAL SPECIFICATIONS: CURRENT STAGE OF DEVELOPMENT: Available for demonstration INTELLECTUAL PROPERTY RIGHTS (IPR): Patent Applied for but not yet Granted MARKET APPLICATIONS: The company’s encapsulation technology can be broadly applied for development of treatments of a number of diseases outside its oncology focus including chronic or genetic diseases (Diabetes, Parkinson’s disease, haemophilia A and B, peripheral artery disease). The technology can also be applied in immunotherapy and biomolecule augmentation. TYPE OF COLLABORATION SOUGHT:  License Agreement  Manufacturing agreement/Prototyping PARTNER PROFILE: Partner Qualification Criteria The company seeks partners, regardless of size, who have a need to encapsulate cells for bioproduction or as nononcological, biomedical products. Potential partners should thus have expertise in the growth of the cells, as well as biological assays for their cells and products or activities that they may produce. In the case of biomedical products, the partner should have expertise in the indication(s) they would like to treat and have relevant animal models in place. Tasks to be Performed by Partner Potential partners should provide specialised cells for encapsulation and, preferably, relevant bioassays specific for the products or activities that the cells produce. In the case of biomedical products, the partner should have expertise in the indication(s) they would like to treat and have relevant in vitro and/or animal models in place. Support Provided by Your Organisation The company’s manufacturing assets, together with its enormous encapsulation know-how and the first market approved encapsulated product, open options for the application of the company’s unique encapsulation technology platform to many different areas outside of the oncology focus. The company plans to commercialize this technology platform by co-development activities or by establishing out-licensing deals with other companies that have cell systems that they would like to encapsulate.
Market application:
-  HUMAN/ANIMAL HEALTH -  Health issue treatment
Entry/Update:	2006-10-20  /  2007-01-18