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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.
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