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Buenas prácticas de fabricación (GMP) de productos de terapia celular

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOES20141202001
Publicado:
18/06/2015
Caducidad:
17/06/2016
Resumen:
Una pyme vasca de biotecnología está especializada en desarrollo y fabricación de nuevos productos de terapia celular e ingeniería de tejidos para medicina regenerativa y está acreditada como fabricante GMP de productos de terapia celular por la Agencia Española de Medicamentos (EMEA). La empresa fabrica productos de terapia celular para hospitales y compañías farmacéuticas y biotecnológicas autorizadas para utilizar estos productos en sus pacientes y dispone de una sala limpia de 65 m2 con capacidad para tratar 200 muestras al año. Se buscan socios con el fin de establecer acuerdos de servicio, licencia o comercialización con asistencia técnica.

Details

Tittle:
GMP (Good manufacturing practice) production of different cell therapy products
Summary:
A Basque biotechnology SME is focused on the development and production of new cell therapy and tissue engineering products for regenerative medicine and is certified as GMP producer of cell therapy products by the Spanish Medicines Agency (EMEA). The company is searching the partners for services, license and/or commercial agreements with technical assistance.
Description:
The Basque biotechnology SME is an authorised GMP cell therapy products producer by the EMEA (European Medicines Agency). They are able to produce GMP cell therapy products as chondrocytes, fibroblasts or adipose derived mesenchymal stem cells (ADMSC) for hospitals, biotech and pharmaceutical companies which have the authorisation for patients use of these products. They have a clean room of 65 square meters with capacity to treat 200 patients' samples per year. Nowadays, this SME is expanding and is ready to produce other cellular products in its GMP facilities.
Regenerative medicine is a very innovative area where the first clinical trials are nowadays going on. Therefore, there are very few companies specialised and with adequate personnel and facilities for GMP production of the final or intermediate cellular products because it requires a huge investment in the facilities, technology, regulatory issues and highly specialised personnel. The technology offered by this SME is very convenient for those organisations not specialised in producing but interested in patients application of adult stem cells.
The company is looking for collaboration agreements (commercial, services or license) with partners for transferring its technology. The company is also looking for organisations interested in contracting the GMP production of cell therapy products.
Advantages and Innovations:
The GMP production of cell therapy products requires a huge investment in the facilities, technology, regulatory issues and highly specialised personnel. The main advantage of working with this SME is to avoid this huge and time-consuming investment in customers not specialised in producing but interested in patients application of adult stem cells. The company has both the capabilities for GMP production of cell therapy products and the know-how for this technology application and transfer.
Stage of Development:
Already on the market
IPs:
Secret know-how

Partner sought

Type and Role of Partner Sought:
The company is looking for services, license and/or commercial agreements with technical assistance. It is looking for in customers interested in contracting the GMP production of cell therapy products. Also, it is willing to achieve agreements with partners for transferring this technology. The company is looking for partners as public or private hospitals, pharmaceutical and/or biotechnology companies.

Client

Type and Size of Client:
Industry SME 11-49
Already Engaged in Trans-National Cooperation:
No
Languages Spoken:
English
Spanish

Keywords

Technology Keywords:
06002002 Biología celular y molecular
06001013 Tecnología médica / ingeniería biomédica