Spain is making waves in the biotech sector, spearheading a cost-effective approach to chimeric antigen receptor (CAR)-T cell manufacturing that could revolutionize the field. By leveraging Grade C cleanrooms, rather than the pricier Grade B facilities, Spanish academic centers are slashing the per-treatment cost to under €100,000 — a significant reduction when compared to the steep price tag of over US$400,000 attached to commercial products.
This ingenious model is not only cost-effective but also fosters seamless coordination between research, manufacturing, and clinical care. It weaves an integrated ‘bench-to-bedside’ blueprint that can potentially revolutionize efficiency and outcomes in the biotech industry.
The innovative approach is a product of the advanced therapy ecosystem in Spain, highlighted in the bi-weekly panel discussion, ‘Behind the Headlines’. The panel comprised of Fabian Gerlinghaus, CEO of Cellares; Alexander Seyf, co-founder and CEO of Autolomous; and Knut Steffensen, director of the Karolinska Institutet and University Hospital ATMP Center. They underscored the need for better integration across the therapeutic value chain and highlighted persistent inefficiencies in CGT manufacturing such as duplicated facilities, fragmented digital workflows, and escalating external cost pressures from factors like energy prices and tariffs.
The trio pointed out that the lack of shared infrastructure and harmonized systems continues to hamper scalability and access, while the high manufacturing costs remain a formidable barrier for both developers and patients. The Spanish model, however, is a breath of fresh air, offering a cost-effective alternative that could address these challenges.
The academic approach to CAR-T manufacturing in Spain has been enabled by regulatory flexibility that permits production in Grade C cleanrooms. The model, currently in use in Spanish hospital centers, has not only reduced the per-treatment cost but also brought about a more integrated design that bolsters coordination between research, manufacturing, and clinical care.
The panel also touched upon the implications of BioNTech’s proposed acquisition of CureVac. While some speculate the move to be related to an ongoing patent dispute, the experts opined that the transaction also mirrors broader strategic concerns, including a cooling vaccine market and a desire to bolster oncology capabilities and mRNA manufacturing scale.
The CureVac deal could be indicative of a shift in acquisition strategies across the mRNA sector. As the field rapidly evolves, companies are likely to look for ways to shore up competitive advantages.
As the biotech industry continues to evolve, innovative approaches like Spain’s Grade C cleanroom model could pave the way for more cost-effective, efficient, and integrated solutions. The industry is ripe for disruption, and it seems the Spanish academic centers are leading the charge with their pioneering work in CAR-T manufacturing.
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