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GMP (Good manufacturing practice) production of cell therapy products

Country of Origin: Spain
Reference Number: TOES20181119002
Publication Date: 28 December 2018

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

Requested partner

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.

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