On April 5th we received in our plant in León the visit of a wide representation of the members of BioSim and the team of the association, headed by Joaquín Rodrigo, President, and Regina Múzquiz, Managing Director. Emmanuelle Lepine, General Manager of mAbxience, Naouel Zouaghi, Marketing and Public Affairs director and Luisa Amoedo, site director, welcomed the group upon arrival.
The plant managers guided the group through the facilities providing them with information of the processes carried out at the plant, the R&D laboratories, quality control and production, always respecting the most rigorous sanitary standards of Good Manufacturing Practices and Good Laboratory Practices (GMP and GLP). In fact, the plant was designed by the workers themselves so that visitors can view all the facilities and processes that are carried out in situ through aisles provided with large windows surrounding the production rooms, thus ensuring integrity of the biosimilar manufacturing process.
At the end, a video was projected with the evolution of the plant, which allows to witness the changes and improvements that have been made in these last 3 years.
The plant, with a surface of more than 5,500 square meters, is one of the largest facilities in Europe with the innovative single-use technology, which uses single-use materials in most of its processes, from the defrosting of the cellular banks to the purification and formulation of the final product, through the cultivation and preparation of all necessary media and solutions.
This innovative single-use bioreactor technology provides a demanding quality control and optimization of the production lines, minimizing any possibility of cross contamination throughout the processes. In addition, it is an efficient and environmentally friendly technology because, for example, it reduces the consumption of water and cleaning agents by more than 80%.
Our León plant is one of the main worldwide references in the production of biosimilars and an exponent of the innovation processes that are behind the production of these medicines. Currently we have two biosimilars developed and already commercialized in Argentina, and four more in the development phase.