Vienna, Austria (PRWEB) May 10, 2006
Austrianova Biotechnology sets up unique industrial manufacturing process for the GMP compliant production of encapsulated living cells.
Austrianova today announced that it has started industrial production of its lead product NovaCaps®. Austrianova is the first company worldwide that has been successful in developing a market scale, GMP compliant, industrial production process for encapsulated cell products. The implementation of the proprietary and unique manufacturing plant was realised with an investment of 6 Mill. Euro and took two and a half years. Austrianova’s GMP manufacturing plant has a capacity of 40,000 vials per year, sufficient to meet the projected demand for NovaCaps®. Contract partner, Miltenyi Biotec, supported Austrianova with expertise in the area of GMP production of biologics as well as providing GMP compliant production facilities in Frankfurt, Germany.
The set up of an industrial scale production of NovaCaps® represents an important advance for Austrianova since it demonstrates the industrial feasibility of the company’s reference project, a prerequisite for future commercialisation. With this advance, the manufacture of encapsulated cell therapies to medicinal product specification finally has become a reality. This opens very promising strategic options for the activation, regulation and transport of drugs since virtually any cell type can be encapsulated to immunoprotect the cells and to confine them to the site of delivery upon application into a patient. Moreover, the establishment of industrial scale, medically compliant production opens the doors for the application of Austrianova’s encapsulation technology to uses beyond the company’s immediate oncological focus. “Austrianova has reached an important milestone on its way to become a next generation drug delivery company," stated Thomas Fischer, Austrianova’s Managing Partner for Finance & Administration.
“The encapsulation technology is novel even at laboratory scale, but it was a tremendous challenge to scale the procedure for industrial production," commented Brian Salmons, Austrianova’s Managing Partner for Research & Development. New machinery had to be designed and developed by Austrianova personnel to meet GMP standards. Stringent criteria, in terms of reproducibility and product quality, which has to maintain critical tolerances, had to be fulfilled. In addition, comprehensive documentation standards needed to be established.
NovaCaps® has received orphan drug designation for the currently most poorly treatable indication, pancreatic cancer, from the European Medicines Agency (EMEA). The ability to provide consistent and quality assured batch manufacturing of NovaCaps® satisfying European market demand is a prerequisite for EMEA market authorisation based on the upcoming phase III clinical trial data planned to start early 2007.
About Austrianova Biotechnology GmbH:
Since the company was founded, in December 2001, Austrianova has matured from the first Biotech spin-off of the University of Veterinary Medicine, Vienna to its present status as a development focussed producer of biological medicaments with an innovative pipeline. Austrianova represents a precedent for the successful collaboration of university and industrial partners, the so-called integration model. The Company is at the forefront of the growing Austrian Biotechnology Industry and employs a staff of 25, with an additional 35 University staff.
The cell based therapy, NovaCaps®, is based on the encapsulation of genetically modified cells that are implanted in the vicinity of solid tumours. Encapsulation of the cells is achieved using a unique procedure and protects the cells from the patients immune system. The cells have been modified to produce an enzyme that converts a non-toxic chemotherapeutic agent to its tumour toxic form at the site where it is needed (Prodrug Therapy). The NovaCaps® treatment extends the survival of the patient while reducing side effects and improving the quality of life. Austrianova has received orphan drug status for NovaCaps® in the E.U. for the treatment of pancreatic cancer.
Pancreatic cancer is one of the most serious forms of cancer with a poor prognosis and limited treatment options. It is estimated that each year there are around 120,000 new cases of pancreatic cancer in the E.U., U.S. and Japan – around 50,000 of these occur in the E.U. alone translating into an E.U. market volume for NovaCaps® of around Euro 300 million.
About GMP (Good Manufacturing Practice):
The term “Good Manufacturing Practice”, abbreviated to GMP, was introduced by the American Health Authority, FDA (Food and Drug Administration). GMP requires that all critical steps in the production of medicinal products are reproducible and controlled as well as precisely documented. The whole pharmaceutical and biotech industry adheres to GMP for the production of medicines. GMP certification is granted by the regulatory authorities and inspection of production facilities for compliance with GMP is regularly performed.
About Miltenyi Biotec GmbH:
Miltenyi Biotec is one of the most successful German Biotech companies. Miltenyi Bioprocess provides GMP contract manufacturing support for the production of pharmaceutical products.