A strategic project that consolidates 53Biologics ‘ biopharmaceutical capacity in Spain.
Pablo Gutiérrez, CEO of 53Biologics, shares his vision on how our collaboration has contributed to the start-up of their new GMP plant in Valladolid. A strategic project that strengthens their capacity for the development of biological drugs in Spain.
Conceptual design up to the highest standards
One of the key points of the project was the conceptual design of the new facility. As Gutierrez points out, “the conceptual design of a GMP facility is crucial to the success of clinical trials.”
At Klinea, we bring our experience in pharmaceutical engineering to define a design that not only complies with current regulations, but also meets the technical challenges of a modern biopharmaceutical plant.
Innovation and space optimization
The project included the design of a pilot plant in the basement of the existing 53Biologics building, a major challenge that required making maximum use of the available space without compromising functionality or safety.
“Klinea has been able to optimize the use of space to improve our productive capacities in an efficient manner” – Pablo Gutiérrez
This solution allows the company to increase its clinical batch production capacity without the need to significantly expand its infrastructure.
Production and quality control, seamlessly integrated
In GMP projects, correctly integrating the production and quality control areas is one of the biggest challenges. In this case, “Klinea has ensured the correct segregation of areas, ensuring both operational efficiency and regulatory compliance,” says Gutiérrez.
Thanks to this approach, a smooth and safe workflow has been achieved, which is essential for the smooth operation of the new plant.
A partnership based on trust and specialization
Gutiérrez also highlights what, according to him, has made the difference: “its international experience, its specialization in biopharma and its personalized approach”.
From day one, the collaboration was based on mutual trust, closeness and a clear focus on results. A way of working that defines our style and that we bring to every project.
Designing the future
With the new 53Biologics plant, we are not only expanding our production capacity, but also helping to position the company as a European benchmark in the development and manufacture of biological drugs.
“This project is an investment in the future that will allow us to be more competitive and respond more quickly to our customers’ needs” – Pablo Gutiérrez
A real case that reflects how, at Klinea, we design solutions that help transform the future of the pharmaceutical industry.
