Histocell obtains AEMPS authorisation and GMP certification for its new manufacturing plant for cell therapy and associated biological medicinal products
The biopharmaceutical company reaffirms its commitment to local innovation and manufacturing with the extension of the authorisation obtained in 2011.
It will allow it to increase its current production capacity tenfold and boost its CDMO services.
The new manufacturing plant has obtained authorisation from the Spanish Agency for Medicines and Medical Devices for the GMP manufacture of cell therapy and biological medicinal products, such as secretomes, which allows to apply these therapies in all clinical phases (I-III) as a step before the marketing phase.
Tenfold increase in production capacity.
With more than 800 m2, this plant multiplies the current manufacturing capacity tenfold, making it one of the largest in Spain and capable of manufacturing both pilot batches, and large industrial-scale batches of clinical-grade cell banks, intermediate products, and end products.
Thanks to its seven clean rooms, large cell Banks room, Fill & Finish room, and quality control laboratories, Histocell now has fully equipped facilities for the manufacture and scale-up of both autologous and allogeneic therapies of mesenchymal stem cells, secretomes, iPSCs, as well as being immersed in projects for the manufacture of CAR-T.
CDMO unique in Spain and with international projection.
Histocell brings 20 years of experience developing cell therapy drugs to offer its clients development and process optimisation services to take their medicinal products to the GMP and industrialisation phases.
The AEMPS authorisation as a manufacturing laboratory (MIA Reference 1174, Laboratory Authorisation No. 4269E) allows Histocell to provide its services to national and international public entities and private companies, such as its current customers in Europe and Japan.
The activity of this new plant will enable the company to double its turnover by 2024 and position itself as a benchmark CDMO for the manufacture of cell therapy and associated biologics medicinal products on an international scale.
