From Clinical Leadership to Industrial Scale-Up: A Shared Ambition for the Future of Advanced Therapies in Catalonia

Under the ATMP umbrella, a wide range of approaches coexist, each with different industrial, regulatory and healthcare requirements. In the case of cell and gene therapies, which account for much of the field’s current development, three major development and manufacturing paradigms can be identified and are expected to coexist in the coming years: autologous models, allogeneic models and in vivo approaches. This is not a regulatory classification, but rather three distinct development models that shape manufacturing, scalability, logistics and how these therapies reach patients.

In autologous therapies, the starting point is the patient’s own cells. Each treatment requires these cells to be collected, modified or expanded under controlled conditions, and then reintroduced into the same patient. This means that manufacturing is not merely a technical stage, but an essential part of the product and its value proposition. It requires highly coordinated local hospital networks capable of integrating the necessary technical and regulatory expertise and minimizing the time between cell collection, modification, and reinfusion into the patient.

The second model is allogeneic therapies. In this case, cells come from a donor or a standardized cell source and are modified or prepared to become a therapeutic product that can be administered to multiple patients. The ambition of this model is to turn modified cells into more standardized, off-the-shelf medicines that can be manufactured in batches, enable better logistical planning, and potentially reduce the cost per treatment. This approach paves the way for models closer to industrial manufacturing, with centralized production, advanced analytical control, and greater involvement from the pharmaceutical and biotechnology industries.

The third model is in vivo therapies. In this case, the therapeutic modification is not performed on cells extracted and manipulated outside the body, but directly within the patient. The product is not a modified cell, but rather a vector, nanoparticle, or other delivery platform that carries a genetic or molecular payload designed to correct, modulate, or reprogram a biological function. This approach may also simplify clinical logistics, more closely resemble the traditional pharmaceutical model, and facilitate larger-scale centralized production.

These three models will not necessarily compete with one another; rather, they will coexist and address different clinical needs. Autologous therapies may remain essential in settings requiring a high degree of personalization and close coordination with hospitals. Allogeneic therapies may pave the way for more scalable and readily available cell-based products. And in vivo therapies may represent a new frontier by bringing genetic or cellular modification directly to the patient, supported by broader manufacturing and distribution models.

For this reason, when we discuss the future of advanced therapies in Catalonia, we are referring to the need to build a system capable of supporting therapies along different development pathways. The challenge is therefore not only to develop effective therapies, but also to establish the right models so that each one can follow the pathway it requires and reach patients safely, sustainably, and competitively.

“In just a few years, advanced therapies have gone from being a promise to becoming a clinical reality for certain patients. The results achieved with CAR-T therapies, gene therapies, and other advanced therapy medicinal products have shown that it is possible to deliver clinical benefits that were difficult to achieve with conventional approaches,” says Joaquín Arribas, director of the Hospital del Mar Research Institute and group leader at the Vall d’Hebron Institute of Oncology, in an interview for the ATMP Catalonia website. “Even so, I believe we are still at a relatively early stage. In the coming years, we will see more sophisticated therapies capable of overcoming resistance mechanisms, working in more complex tumor environments, and reaching a larger number of patients. The potential is enormous, particularly in situations where current treatments remain insufficient.”

Catalonia: Exceptional Capabilities, but a Still-Fragmented Production Chain

Catalonia is in a privileged position, bringing together world-class biomedical research, leading hospitals, and clear European leadership in clinical trials. One successful example of these capabilities is the development of ARI-0001, the first publicly funded academic CAR-T therapy in Europe to be authorized by the Spanish Agency for Medicines and Medical Devices (AEMPS), which has already benefited more than 650 patients.This strength is further reinforced by ATMP Catalonia, a Biocat-coordinated network comprising more than 70 organisations that connects hospitals, research centres, companies, investment funds and public authorities. The network has also established ATMP Day, held this September, as an annual meeting point for the ecosystem.

Despite these capabilities, Catalonia faces a strategic gap: it excels at the initial and final stages, but there is a clear discontinuity in the value chain when it comes to scale-up.

This is the view of Avencia Sánchez-Mejías, CEO and co-founder of Integra Therapeutics. “The bottleneck in moving from initial clinical manufacturing to a robust, reproducible process that can support progress toward more advanced clinical and commercial stages is not scientific, but operational: we need professionals with specialized CMC expertise and access to CDMOs with the capacity to scale through to commercial production. At the same time, securing the funding required for the later stages of these advanced therapy products is not easy, and it must often be sought outside Catalonia. Without these resources, moving from a pilot batch to a reproducible process, as required by our FiCAT platform, is the real barrier to bringing these products to patients,” the entrepreneur explains.

The Catalan ecosystem currently has 24 cleanrooms dedicated to producing these therapies, with six more expected to become operational by 2027. However, due to structural and regulatory capacity constraints, scaling up these solutions remains a critical obstacle for both academic projects and startups. The challenge, therefore, is not to add infrastructure in isolation, but to turn existing capabilities into a coordinated value chain.

To consolidate this position, Catalonia must advance two complementary priorities: better organizing and connecting its existing capabilities while fostering specialization, and ensuring access to industrial scale-up services that enable projects to progress beyond the initial stages of development.

According to Alessandra Magnani, Head of the Advanced Therapies and Immunotherapy Platform at Sant Joan de Déu Hospital, “Catalonia has highly valuable scientific, technological and manufacturing capabilities that place us in a distinctive position in Europe. Strategically connecting and coordinating these capabilities would enable us to create synergies, accelerate the development and scale-up of projects and, above all, bring innovative therapies closer to the patients who need them most, including those with rare diseases who have no other treatment options".

Coordinate, Specialize, and Share

The first priority is to evolve from a collection of high-value but still fragmented assets into a functional network. This means accurately mapping the capabilities and specializations of each center, establishing coordination and referral mechanisms, harmonizing procedures where this adds value, and sharing knowledge, infrastructure, and expertise.

This is the context in which NEXCAT was created. The consortium initially brings together the Blood and Tissue Bank, CREATIO-UB, Hospital Clínic Barcelona-IDIBAPS, the Sant Pau Research Institute, the Sant Joan de Déu Foundation, VHIR, VHIO, and Biocat, all of which are members of ATMP Catalonia.

NEXCAT was created to organize, connect, and complement Catalonia’s existing capabilities in advanced therapy research, development, manufacturing, and translation. It aims to identify specializations and gaps while enabling projects to access the capabilities they need throughout their development. At the same time, this structure should allow Catalonia to present itself in Europe not as a collection of independent institutions, but as a coordinated regional ecosystem with critical mass and the ambition to position itself among Europe’s centers of excellence in advanced therapies.

“The competition, both within and beyond Europe, is absolutely fierce", says Julio Delgado, consultant physician in the Hematology Department at Hospital Clínic Barcelona and researcher at IDIBAPS. “Success necessarily depends on close collaboration across the region, making the most of the strengths of the different public and private institutions. In this regard, the creation of new meeting points, such as the NEXCAT network, could be highly relevant.”

The need for collaboration across networks is not unique to Catalonia. Europe is also moving toward models designed to overcome the current fragmentation of the ecosystem, better connect existing capabilities, and strengthen its global competitiveness in advanced therapies. In this context, the European Commission, under the Horizon Europe program, has launched a dedicated call to establish a European network of Centers of Excellence in advanced therapy medicinal products, conceived as regional ecosystems capable of integrating scientific knowledge, technical capabilities, development, manufacturing, and clinical translation to help therapies move more efficiently from research to patients. 

By bringing together its capabilities through initiatives such as NEXCAT, Catalonia aims to position itself as one of these centers of excellence and thereby contribute to a more coordinated, specialized, and competitive European network.

Ensuring Industrial Scale-Up

The second priority is to bridge the gap between manufacturing for the initial clinical stages and reproducible, sustainable production. Catalonia needs an industrial scale-up infrastructure that can ensure continuity for these projects. This platform should have a public-service, nonprofit mission. Its dual nature would be the cornerstone of its impact. On the one hand, it would provide the capabilities required to work closely with industry and startups, enabling them to scale their processes, attract investment, and ensure that their innovations can transition competitively toward global commercialization. On the other hand—and this must be nonnegotiable—it would support collaboration with academic projects focused on rare diseases, which often offer insufficient returns to attract private-sector investment.

Lluís Pareras, founder and managing partner of Invivo Ventures, supports this initiative: “From an investor’s perspective, a public-private CDMO could be instrumental in turning Catalonia’s scientific and clinical excellence into industrializable, investable projects. It would allow process development, analytics, quality, and GMP scale-up to be incorporated from the outset, reducing timelines, capital requirements, and technology-transfer risks. An infrastructure managed according to industrial criteria, with professional governance and connections to private capital and international demand, would greatly strengthen our ecosystem. In advanced therapies, CMC is not a later stage: it is a core component of the product and its value.”

An analysis of the international landscape offers invaluable insights. Today, the benchmark models that most closely align with Catalonia’s ambitions include organizations such as CCRM and its manufacturing platform, OmniaBio, in Canada, and the Cell and Gene Therapy Catapult (CGT Catapult) in the United Kingdom. In Ireland, the National Institute for Bioprocessing Research and Training (NIBRT) provides another particularly relevant component: the integration of biomanufacturing capabilities with specialized training and talent development, a critical factor in sustaining the sector’s growth. At the European level, initiatives such as RegMed XB in the Netherlands also underscore the need to develop shared structures.

This is where the Catalan ecosystem can make a decisive qualitative leap. Rather than competing solely to add square footage or increase the number of cleanrooms, the country’s strategy must demonstrate its ability to connect all the components symbiotically: process development, biomanufacturing, regulation, access to the healthcare system, and the inseparable task of developing highly qualified talent.

A Strategy Aligned with Europe’s Priorities

Strengthening Catalonia’s advanced therapy capabilities forms part of a broader shift in the European agenda. Faced with an ecosystem that remains fragmented, Europe is moving toward models that better connect existing capabilities, strengthen manufacturing and scale-up, and enable projects to progress more efficiently from research to the patient.

This approach is reflected both in the forthcoming European Biotech Act and in initiatives such as the new Horizon Europe call to establish a European network of Centers of Excellence in advanced therapy medicinal products, which aims to structure high-capacity ecosystems as interconnected nodes within a European network.

The objective is not to replicate every capability in each territory, but to build a European network in which the most mature ecosystems can specialize, complement one another, and share resources. This is also Catalonia’s opportunity: to turn its scientific and clinical leadership into translational and industrial capabilities while helping strengthen Europe’s autonomy and competitiveness.