Histocell inaugurates new manufacturing plant for advanced therapy medicinal products

Histocell has inaugurated this morning its manufacturing plant in Larrabetzu, dedicated to cell therapy and biological medicinal products. The facility increases Histocell’s production capacity in this type of products tenfoldand, in this field, it is one of the manufacturing plants with the largest capacity in Spain.

The project has counted on the collaboration of the company Cardiva, a partner of Histocell, and from 2021 part of its shareholding. This incorporation allowed Cardiva to expand the catalogue of references it distributes in Spain – including the Reoxcare product line for wound care – and to enter the field of regenerative medicine. With its participation in the production centre, Cardiva is furthering its commitment to the development of advanced therapy products and local manufacturing, in close proximity to basic healthcare systems.

The inauguration was attended by Ainara Basurko, Diputada Foral de Promoción Económica, viceconsejera de Tecnología, Innovación y Transformación Digital, Estíbaliz Hernáez, viceconsejera de Administración y Financiación Sanitarias, Nerea Urien, alcalde de Larrabetzu, Iñigo Gaztelu, and the president of Cardiva, Ignacio Vega, who toured the facilities in the company of Histocell’s general manager, Julio Font, and Histocell’s assistant manager, Marta Acilu.

Julio Font, highlighted the moment as “A very important milestone for the present and future of the organisation. The present, because it is already leading to our growth and specialisation, and the future, because it gives us access to a new dimension of products and services for the coming years.”.

These new facilities represent the expansion of the manufacturing plant for cell therapy and biological medicinal products that Histocell has been operating since 2011 in the Bizkaia Technology Park and needed to grow in size. With an initial surface area of 65sqm, it now has an extension of 800sqm that integrates a manufacturing area and quality control laboratories.^.. Histocell will thus go from being able to treat up to 150 patients per year to being able to treat more than 1,200 patients per year.

The plant manufactures cell therapy medicinal products based on viable cells of different types, and biological medicines, based on substances secreted by the cells.

Industrial production and innovation

The plant is designed to produce not only cell therapy medicinal products but also to cope with the production of biological medicinal products such as secretomes, exosomes and CAR-T drugs. It also has a pilot plant to develop new technologies that can later be incorporated into production processes.

With manufacturing commitments already signed with various national and international clients, the plant will start production in the first half of 2023, after completing the validation processes and obtaining authorisation from the Spanish Medicines Agency.

The entire project involved an investment of 2.5 million euros and was carried out in one year. It has received financial support from the 3i programme of the Diputación Foral de Bizkaia. The installation of the pilot plant has been supported by the budget of the Department of Economic Development, Sustainability and Environment of the Basque Government, through the Project for the Acquisition of Scientific-Technological Infrastructures – Osansunberri.

Reference as CDMO partner

With this phase 2 of its Larrabetzu factory, Histocell completes the path initiated in 2018 with the inauguration of Histocell Factory, which meant moving from research at laboratory level to scale production and under GMP standards of its pharmaceutical developments.

This plant, together with the experience of Histocell’s team in the development of advanced therapies products, positions Histocell as a CDMO partner of reference in the development and manufacture of medical devices, dermo-cosmetics and medicinal products in the field of regenerative medicine.