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Sistema de producción rentable y de alto rendimiento de factores de coagulación de la sangre similares a los humanos para el tratamiento de la hemofilia

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOAT20150529001
Publicado:
22/07/2015
Caducidad:
21/07/2016
Resumen:
Una universidad austríaca ha desarrollado un sistema en hongos para la producción de factores de coagulación sanguínea recombinantes enzimáticamente activos. La universidad ha modificado genéticamente el organismo Aspergillus nidulans y ha demostrado que la protrombina gamma-carboxilada puede expresarse y purificarse de forma eficiente en caldos de fermentación del hongo. Estos factores pueden reducir el riesgo de infecciones de la sangre en el tratamiento de la hemofilia. El nuevo desarrollo permite la producción estable de factores de coagulación sanguínea de forma más económica y con un rendimiento mayor que los concentrados de factores basados en humanos. La universidad busca socios industriales con el fin de establecer acuerdos de licencia, comercialización y cooperación técnica.

Details

Tittle:
Cost-effective, high-yield production system for human-like blood-clotting factors for haemophilia therapy
Summary:
An Austrian university has developed a production system in fungi to produce an enzymatically active recombinant blood clotting factor. These factors can essentially reduce the risk of blood infections during haemophilia therapy. The world-wide new development enables a stable production of blood clotting factors, cheaper and higher yielding than human-based factor concentrates. They are looking for industrial partners for licence agreements, commercial and technical cooperation agreements.
Description:
In the past 20 years recombinant blood clotting factors have been developed, reducing or eliminating the risk of blood-borne infections during haemophilia therapy. Today, recombinant factors are approved worldwide for therapy. They are normally produced in mammalian systems.

Mammalian cell systems and their fermentation and purification process, and especially the extensive quality assurance and testing, contribute enormously to the cost of the final product. For mammalian expression systems, the fermentation procedure is expensive and yields are much lower than those reported for various microbial systems, i.e. fungi.

Yeasts and other fungi represent promising alternatives, because they provide well-studied cheap systems and can be grown in chemically defined media without any animal derived material. However, yeasts and fungi are deficient in a system modifying proteins post-translationally in terms of gamma-carboxylation. So until now, they have not been able to produce recombinant blood-clotting factors.

An Austrian university has genetically modified the model organism Aspergillus nidulans and demonstrated that gamma-carboxylated prothrombin can be expressed and purified efficiently from fungal fermentation broths. Moreover, biological activity of the fungal produced prothrombin and its accompanying functional gamma-carboxylation could be demonstrated in various activity assays. For the first time an engineered functional, heterologous Vitamin K dependent-protein (VKD protein) production system has been established.

For the production of functional mammalian-like clotting factors, fungal cells have to be engineered, owing to their inability to post-translationally modify glutamate residues (=gamma-carboxylation) of VKD dependent proteins (i.e. clotting factors). The reaction is performed in the endoplasmic reticulum by VKD gamma-carboxylase and vitamin K epoxidase. Proper localization of the carboxylase and epoxidase was established and enzymatic activity of both gamma-carboxylase and vitamin K epoxidase was confirmed in vitro and in vivo.

The system was patented and a PCT application was filed in 2014. Next it will be necessary to develop and optimize the system in industrially suitable production strains to increase yield and uniformity of the final product.

2010 the market for haemophilia therapy was about 5.6 billion US$ with a growth of 6.7 % between 2002 and 2010. It was therefore one of the fastest growing markets. The production of recombinant blood clotting factors will become more important in the next few years. There is a high market potential for a future product, with lower costs related to production and quality assurance.

The Austrian university is looking for a commercial partner from industry to further develop and exploit the technology. This could be in the form of a commercial agreement with technical assistance, a technical cooperation agreement or a license agreement. The university will provide its expertise for the further development into an industrially applicable system.
Advantages and Innovations:
For the first time an engineered functional, heterologous VKD-protein (Vitamin K dependent protein) production system was established, which is not based on mammalian cells.

Advantages:
- well-studied fungi production system, therefore well-known and stable factors of production
- more cost-effective fermentation procedure and higher yields in comparison to mammalian systems
- human-like carboxylated functional blood clotting factors, equals quality of mammalian derived blood-clotting factors but cheaper and with higher yields!
Stage of Development:
Under development/lab tested
IPs:
Patent(s) applied for but not yet granted

Partner sought

Type and Role of Partner Sought:
Type of partner sought:
Industry, commercial partner to further develop and exploit the technology. This could be in the form of a commercial agreement with technical assistance, a license agreement or a technical cooperation agreement.

Specific area of activity of the partner:
Production and development of blood-clotting factors (and other carboxylation-dependent proteins)

Task to be performed by the partner:
Develop and optimize the system in industrially suitable production strains to increase yield and uniformity of the final product. The university will provide its expertise for the further development into an industrially applicable system.

Client

Type and Size of Client:
University
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
German

Keywords

Technology Keywords:
06002008 Microbiología
06001015 Productos farmacéuticos / medicamentos
06002003 Tecnología de enzimas