Cellares Secures $257M to Scale Global Cell Therapy Manufacturing

The cell therapy landscape is currently undergoing a fundamental transformation from localized, manual production toward a standardized industrial model, a shift underscored by the recent announcement that Cellares has closed a $257 million Series D financing round.1 Co-led by BlackRock and Eclipse, the investment brings the total funding for the organization to $612 million. This capital infusion represents more than just financial growth; it validates a move toward a new category of service provider known as an integrated development and manufacturing organization (IDMO), according to a Cellares news release.1 The IDMO model seeks to solve the persistent challenges of capacity, cost, and consistency that have limited the reach of personalized medicines to a small fraction of the global patient population. The Cellares IDMO model is “vertically integrated across technology development, biopharmaceutical contract manufacturing, and consumables manufacturing,” says Fabian Gerlinghaus, co-founder and CEO of Cellares, in an interview with PharmTech. “This vertical integration eliminates middle-men which helps Cellares offer the lowest cost of manufacturing in the industry - the other contributing factors being a 90% reduction in required labor and facility space.”

Can High-throughput Automation Address the Current Bottlenecks in Cell Therapy Production?

To modernize what Cellares notes as the traditional method of manufacturing cell therapies long characterized by labor-intensive, manual steps that are difficult to scale across international markets, the new funding will support a fully automated smart factory model via the continued deployment of the company’s Cell ShuttleTM and the Cell QTM platforms.1 The Cell Shuttle operates as an automated, end-to-end, closed system for the production of various cell therapy modalities.

“The Cell Shuttle integrates centrifugation, magnetic cell sorting, electroporation, bioreactor-based expansion, and sterile transfer into a fully-closed, single-use, universal and programmable consumable cartridge. Different modalities run on the same universal hardware design,” saysGerlinghaus. “What changes between a CAR-T and a TCR-T program are software-controlled parameters such as timing, temperature, and cell density thresholds. We have moved the process configuration problem from hardware into software. Each Cell Shuttle processes 16 patient batches in parallel and can produce up to 2,800 patient doses per year.”

In tandem, the Cell Q platform “automates sample preparation, assay execution, and data capture, and feeds QC data directly into electronic batch records,” notes Gerlinghaus. “This removes the quality control bottleneck that typically emerges when manufacturing throughput increases but QC remains manual. Where manual cell therapy manufacturing involves writing 500 pages of quality documentation by hand on paper, Cellares is moving the industry from paper to electronic batch records and from manual generation to auto-generation.” By integrating these two technologies, an IDMO can achieve approximately ten times the throughput of a conventional contract development and manufacturing organization (CDMO) while occupying a similar physical footprint.

This efficiency, according to Cellares, has profound implications for facility planning and human resource management within the industry.1 Where a traditional contract manufacturer might require ten facilities to reach commercial-scale capacity, the automated smart factory model requires one. Also, the staffing requirements for such a facility are reduced from thousands of trained professionals to hundreds. This reduction in labor intensity is particularly relevant given recent reports of rising attrition risks and eroding security within the broader bio-pharmaceutical workforce. “Smart Factories are built around our Cell Shuttles for fully-automated manufacturing and the Cell Q systems for high-throughput quality control,” adds Gerlinghaus. “All instruments are connected by software that maintain chain of custody (COC), chain of identity (COI), and auto-generates electronic batch records. Across four sites, we can deploy 85 Cell Shuttles with room to expand, delivering roughly 10x the productivity with about 90% less labor and 90% less facility space.”

Joe Fath, Partner and Head of Growth at Eclipse, highlighted the necessity of this transition by stating,1 “For decades, cell therapy manufacturing has been constrained by artisanal, manual processes. Cellares has shown that integrated and high-throughput automation can meet regulatory standards, support commercial programs, and scale globally to unlock life-saving cell therapies for hundreds of thousands of patients worldwide.”

What Role do Regulatory Designations and Global Smart Factories Play in Scaling these Modalities?

Building a resilient supply chain for personalized medicine requires a decentralized yet standardized network of manufacturing hubs. The current expansion involves the construction of automated smart factories in South San Francisco, California; Bridgewater, New Jersey; Leiden, the Netherlands; and Kashiwa City, Japan. These sites are designed to provide an unconstrained supply of therapies for hundreds of thousands of patients annually, moving the industry closer to the goals of digitalization and advanced manufacturing processes.

“Cellares is building supply-chain resilience by owning the critical IP, vertically integrating where it matters, and designing redundancy into both sourcing and operations” notes Gerlinghaus. Wherever possible, we avoid single-source suppliers. When single sourcing is unavoidable, we qualify redundant sources across regions to ensure continuity.

“From an execution standpoint, we run world-class planning and scheduling on a digital backbone that plans, schedules, monitors, and reports supply performance, with forecasting processes to anticipate demand and identify risk early. Materials and warehouse management are used to maintain targeted inventory levels, and our manufacturing and release operations are supported by integrated SAP ERP, MES, and LIMS to deliver drug product on time with audit-ready traceability.

“Logistics is treated as a core capability, with a robust vein-to-vein Chain of Identity and Chain of Custody strategy, shipping validation and courier management, and 3PL storage solutions. Our team has implemented S&OP for multiple commercial autologous cell and gene therapy companies, and we continuously optimize our ERP to sustain reliable supply.

“Finally, vertical integration of consumable cartridge manufacturing strengthens business continuity. We operate a Cellares-owned consumable cartridge manufacturing facility in Malaysia (~100,000 square feet), established as a legal entity in April 2024, with first cartridge produced in March 2025 and ISO 13485 certification targeted in 2026. In parallel, we have qualified additional third-party suppliers as backups. The result is lower manufacturing cost for partners and a more resilient, multi-region supply chain for personalized medicines.”

Regulatory confidence is another cornerstone of this industrialization effort. The automated platform has already received the FDA advanced manufacturing technology (AMT) designation, a status intended to expedite the review of regulatory submissions that utilize the platform.1 “The AMT designation allows partners manufacturing on the Cell Shuttle to reference our AMT designation in their regulatory submissions, which enables priority and expedited review,” explains Gerlinghaus. “For companies navigating CMC: engage regulators early, align on comparability strategy before you need it, and bring end-to-end manufacturing data that demonstrates control and performance. Our designation was earned through data, not promises.”

Gerlinghaus adds that while “the hardware and consumable are standardized, the software-driven process design remains fully flexible during development and optimization. Process parameters, including electroporation voltage, bioreactor perfusion rate, harvest wash concentration, and volume or timing of sampling points, are all configurable. Once the product moves into the clinic, there are still opportunities for continuous process improvement based on clinical outcomes, while maintaining the reliability, consistency, and control that come with automation.”

Andrew Farris, managing director at BlackRock, commented on the strategic importance of this development, noting, “Cellares is building the high-tech, industrial backbone required for cell therapy to scale globally. Validated and cutting-edge automation, regulatory recognition, and growing commercial demand make Cellares a category‑defining platform in a rapidly growing global market projected to reach tens of billions of dollars per year over the coming decade.”

The industry’s appetite for this automated approach is already visible in significant commercial agreements. For instance, Bristol Myers Squibb entered a $380 million manufacturing agreement with Cellares in 2024 to reserve capacity within this global network.2 This trend suggests that the move toward high-tech infrastructure is no longer theoretical but a practical requirement for commercial success. As the sector looks toward the first half of 2026 for clinical manufacturing and 2027 for commercial-scale operations, the focus has shifted from scientific discovery to industrial execution.1 Gerlinghaus summarized this pivotal moment1: “The barrier to curing more patients is no longer scientific – it is industrial. With FDA validation, global commercial demand, and the capital to scale, we are building the high-tech infrastructure required to deliver cures and life-changing treatments worldwide. This financing puts Cellares on a clear, disciplined path toward becoming a public company.”

Additional support for this global initiative comes from a diverse group of investors, including Baillie Gifford, T. Rowe Price Investment Management, and the Duquesne Family Office.1 This broad financial backing reflects the growing realization that the future of cell therapy relies on a sophisticated digital architecture that ensures quality control through every stage of development. By closing the gap between manufacturing and procurement, the automated IDMO model provides the pharmaceutical industry with the tools necessary to manage operational risks while ensuring a quality product for the global patient population.

References

1. Cellares. Cellares Raises $257 Million Series D Led by BlackRock and Eclipse to Industrialize Global Cell Therapy Manufacturing with Breakthrough Automation. Press release. Jan 28, 2026.
2. Cellares. Bristol Myers Squibb and Cellares Announce a $380M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster. Press release. April 22, 2024.