GMP (Good manufacturing practice) production of cell therapy products

GMP (Good manufacturing practice) production of cell therapy products

Summary
A Spanish (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. Pipeline refers to the products the company has under development.

The company’s facilities include a GMP manufacturing Unit of cell therapy medicines and biological associated products certified by the Spanish drug and medical device agency (AEMPS).

Currently implemented GMP certified processes include both autologous and allogenic mesenchymal stem cells from bone marrow or from adipose tissue and chondrocyte production, as well as its proprietary Cell Therapy Technology Platform: Adipose derived stem cells that have overcome a preconditioning process that enables them to respond with enhanced potential under pro-inflammatory environments. Nowadays, the company is expanding and is ready to produce other cellular products in its GMP facilities and biological associated products (secretomes, conditioned media or exosomes).

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 patented proprietary cell therapy technology platform.

The company has several “Certificates of GMP Compliance of a Manufacturer” for different types of autologous and allogenic fat stem adult mesenchymal cells.
Stage of Development Already on the market
IPR status: Patents granted
Comments Regarding IPR Status
Europe, United Stated, Japan, China, Brazil, Mexico, Canada, Australia and Korea, (India: national phase pending)

Type and Role of Partner Sought
The company wishes to collaborate with biotechnology companies, research centres and Hospitals 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.
Type of Partnership Considered

Commercial agreement with technical assistance
Financial agreement
License agreement

Contact Person: Jana Vavrinova
Phone Number +34 981 337 146
Public Email jana.vavrinova@xunta.es

https://een.ec.europa.eu/tools/services/PRO/Profile/Detail/7f8fd122-5908-48e4-9462-771af95a2e63?OrgaId=1e092650-6ead-462c-aacb-06486fda0e2d 

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