#BIOSPAIN2025 | “A unique opportunity to generate synergies, strengthen international alliances, and continue positioning Spain as a leading biotech hub”

The design of critical environments under GMP regulations has become a strategic element to ensure safety and quality in the manufacturing of bioproducts and advanced therapies. In a sector where flexibility, scalability, and innovation mark the difference between the clinical phase and market entry, having the right infrastructures is decisive.

On these challenges reflects Javier Ramos, Technical Director of Montajes Delsaz, a Spanish company with more than three decades of experience in the design and construction of GMP facilities. In an interview framed within BIOSPAIN 2025, to be held from October 7 to 9 in Barcelona, Ramos analyzes how regulatory and technological evolution is transforming the conception of plants for ATMPs and biologics.

As a Platinum Sponsor of this edition, Montajes Delsaz reinforces its commitment to advancing towards safer, more efficient, and sustainable environments, supporting biotech and pharmaceutical companies in developing innovative solutions that accelerate the arrival of new therapies to the market.

AseBio. What is Montajes Delsaz, what is its trajectory, and what type of projects do you develop within the biotech and pharmaceutical sector?

Javier Ramos. Montajes Delsaz is a Spanish company with more than thirty years of experience in the design and construction of critical environments under GMP regulations. Our work focuses on turnkey projects for the pharmaceutical and biotechnology industries, among others, developing everything from cleanrooms and laboratories to containerized solutions for the manufacturing of advanced therapies (ATMPs).

We stand out by combining technical knowledge with execution capacity. This has allowed us to participate in national and international projects, always ensuring that the facilities meet the highest standards of safety, quality, and operational efficiency.

AseBio. What is the importance of proper critical environment design in facilities working with advanced therapies (ATMPs) and biological products?

Javier Ramos. The design of critical environments is decisive because it conditions the final quality of the product and the safety of the operator. In ATMPs, which are usually sensitive drugs produced in small batches, even minor deviations can have a critical impact. That is why spaces must guarantee environmental control and minimize all types of contamination risks (external, internal, and cross-contamination).

Proper design also allows operations to be more efficient and the plant to be scalable, ensuring it can accompany product growth from clinical phases to commercialization.

AseBio. What are the main technical or regulatory challenges companies face when designing these types of facilities under GMP standards?

Javier Ramos. The main challenge is constant adaptation to a continuously evolving regulatory framework. The upcoming entry into force of the new revision of GMP Part IV will bring greater requirements in risk management. Added to this are technical issues, such as designing spaces that ensure proper segregation and biological containment, as well as the correct classification of cleanrooms. All this must be balanced with the need to maintain efficient and sustainable operations, avoiding oversized designs while ensuring the capacity to grow in the future.

AseBio. What are the key differences between designing a critical environment for ATMPs versus one for traditional biologics?

Javier Ramos. Designing for traditional biologics usually involves standardized, high-volume processes where stability and repeatability are priorities. On the other hand, when it comes to advanced therapies, facilities must adapt to smaller, more personalized batches, which requires much greater flexibility. In these cases, closed systems, modular, or containerized solutions are frequently used, allowing rapid capacity adjustments and the ability to respond to the changing needs of projects in clinical phases or undergoing constant technological evolution.

AseBio. What role does flexibility play in design, especially considering that many ATMP projects are still in clinical phases or under technological evolution?

Javier Ramos. Flexibility is key. Many projects start on a small scale but must be ready to scale up quickly if clinical results are positive. Designing rigid infrastructures implies obsolescence risks and high adaptation costs.
That is why we are committed to modular and containerized designs that allow phased growth, incorporating new areas or processes without compromising validation or stopping existing production.

AseBio. How do technological innovation and digitalization contribute to the design and operation of more efficient and safer critical environments?

Javier Ramos. Technological innovation and digitalization are part of the progressive evolution of good critical environment design. A flexible and scalable infrastructure reaches its full potential when supported by automated systems that reduce human intervention and, consequently, contamination risks. At the same time, digitalization allows real-time monitoring, strengthens the traceability of each operation, and integrates quality data in a centralized way. All this translates into safer, more efficient, and sustainable plants, with lower operating costs and greater adaptability to regulatory changes and market demands.

AseBio. From your experience, what are the most common mistakes to avoid in the early stages of designing a GMP facility for ATMPs or biologics?

Javier Ramos. One of the most common mistakes is failing to properly plan the scalability of the facility, which limits its useful life and later forces much more costly investments. Another mistake is not integrating regulatory requirements from the outset, which greatly complicates the later stages of the project. Finally, daily flows of people and materials are often underestimated, which ends up generating operational inefficiencies and higher contamination risks.

AseBio. Montajes Delsaz is a Platinum Sponsor of BIOSPAIN 2025. What motivated you to support this event in such a prominent way?

Javier Ramos. BIOSPAIN is the main biotechnology forum in Spain and one of the most important in Europe. For us, participating as Platinum Sponsors is a way to reaffirm our commitment to the sector and to give visibility to our expertise in the design of GMP infrastructures for bioproducts and advanced therapies. We want to accompany the companies leading this change and put our capabilities at the service of their projects.

AseBio. What expectations do you have for your participation in BIOSPAIN? What opportunities do you hope to generate or strengthen during the event?

Javier Ramos. At BIOSPAIN we hope to achieve several objectives. On the one hand, to consolidate relationships with clients and strategic partners, and on the other, to learn first-hand about emerging sector needs and the latest technological trends. A unique opportunity to generate synergies, strengthen international alliances, and continue positioning Spain as a leading biotech hub.