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Buenas Prácticas de Manufactura (GMP) de productos de terapia celular

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOES20181119002
Publicado:
14/01/2019
Caducidad:
15/01/2020
Resumen:
Una pyme biofarmacéutica vasca especializada en descubrimiento, desarrollo, producción y comercialización de nuevos productos de terapia celular e ingeniería tisular para medicina regenerativa está explorando alternativas estratégicas y financieras basadas en colaboraciones con socios, servicios, licencias y/o acuerdos comerciales. El objetivo es desarrollar productos de terapia celular propios y ofrecer servicios de Buenas Prácticas de Manufactura (GMP) de productos de terapia celular a compañías, hospitales e instituciones. Las instalaciones de la empresa incluyen una sala limpia de 65 m2 para Buenas Prácticas de Manufactura de productos de terapia celular acreditadas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), con una capacidad de 200 pacientes al año y cuatro procesos simultáneos. Actualmente los procesos de GMP acreditados e implementados incluyen la producción de células madre mesenquimales y condrocitos.

Details

Tittle:
GMP (Good manufacturing practice) production of cell therapy products
Summary:
A Basque biopharmaceutical SME focused on the discovery, development, production and commercialization of new cell therapy and tissue engineering products for Regenerative Medicine is exploring strategic and financial alternatives based on partners´ collaborations, services, licenses and/or commercial agreements to develop proprietary cell therapy products and to provide GMP (Good manufacturing practice) cell production services to companies, hospitals and institutions.
Description:
The Basque biopharmaceutical SME is an authorized ATMP (advanced therapy medicinal products) manufacturing laboratory for its proprietary cell therapy pipeline as well as for third-party production services. The company´s facilities include a 65sqm clean room for the GMP manufacture of cell therapy products certified by the Spanish drug and medical device agency (AEMPS), with a capacity of 200 patients per year and 4 simultaneous processes. Currently implemented GMP certified processes include mesenchymal stem cells and chondrocyte production. Nowadays, this SME is expanding and is ready to produce other cellular products in its GMP facilities. GMP manufacturing facility is further supported by 300 m² of quality assurance laboratories including cell biology and molecular biology laboratories. Company´s customers include hospitals, biotech and pharmaceutical companies conducting cell therapy-based clinical trials.

Regenerative medicine is an emerging and innovative field with several clinical trials ongoing for different indications. The company has the technological, regulatory and commercial experience to capture this growing opportunity, therefore, the necessary skills combined with adequate personnel and facilities for GMP production of final or intermediate cellular products. The technology offered by this SME is very convenient for those organizations that are not specialized in cell therapy manufacturing but who are interested in the clinical application of adult stem cells.

The company is looking for strategic and financial agreements with partners to complete the development and launch of new products based on its proprietary cell therapy pipeline, as well as for organizations interested in contracting the GMP production service of cell therapy products.

Advantages and Innovations:
The GMP (Good manufacturing practice) production of cell therapy products requires a huge investment in the facilities, technology, regulatory issues and highly specialized personnel. The main advantage of working with this SME is to avoid this huge and time-consuming investment in customers not specialized in producing but interested in the clinical application of adult stem cells. The company has both the capabilities for GMP production of cell therapy products and the know-how to apply this technology in a proprietary cell therapy pipeline.
Stage of Development:
Already on the market
IPs:
Secret Know-how

Partner sought

Type and Role of Partner Sought:
The company wishes to collaborate with biotechnology companies, research centres and academy active in the biotechnological sector, particularly, in regenerative medicine. They are looking for strategic and financial opportunities based on collaborations, licenses and/or commercial agreements with technical assistance to develop proprietary cell therapy products and to provide GMP cell production services to third companies, hospitals and institutions, both public or private.

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