Since the León development plant was opened, the team of professionals working there has progressively grown in size and expertise. 50% of them have more than ten years’ experience in the biotechnology industry and they are highly experienced in R&D of monoclonal antibodies.
It is a young, multidisciplinary team with an international profile. With their focus on an area as uncharted as biosimilars, they help to promote the training of young locals in the biotechnology field. This is a task that mAbxience is strongly committed to.
The León plant is one of the main biopharmaceutical development plants in Europe, with fully integrated Single-Use technology. Its facilities cover a surface area of 5,500 square metres, which is distributed as follows:
• R&D laboratories: 200 m2
• Quality Control laboratories: 250 m2
• GMP plant (200 l): 250 m2
• GMP industrial plant (2,000 l): 4,800 m2
The industrial plant has a 2,600 m2 production area, a 1,000 m2 warehouse and a 1,200 m2 service area.
mAbxience is the first plant in Europe to implement Single-Use technology in most of its processes, from cell bank thawing to purification and formulation of the final product. It is also used in the cultivation process and the preparation of all the necessary media and solutions.
The incorporation of Single-Use bioreactors is one the greatest innovations in the industry and provides a double advantage. On one hand, it provides greater flexibility, allowing products to be changed in record time. On the other hand, it eliminates any possibility of cross contamination throughout this process.
Furthermore, this technology allows for significant savings in resources used during the production process. It mainly curtails the consumption of water and cleaning agents, lowering their use by 80% and 90% respectively since they are not needed to clean the reactors. This allows the environmental impact of our facilities to be reduced.
The biotechnological manufacturing facility has been co-financed with funds from The European Regional Development Fund and The Board of Castilla y Leon through the Agency of Innovation, Finance and Business Internationalization of The Board of Castilla y Leon within the grants of Special Interest Incentives. File number LE/685/IE