The Treatment Is Personal. Manufacturing Must Become Scalable.
Fabian Gerlinghaus, Co-Founder and CEO of Cellares, is pursuing a challenge that sits behind some of modern medicine’s most promising treatments: how can therapies made from living cells be manufactured reliably, repeatedly, and at a scale that reaches more patients?
Cell therapies can use a patient’s own immune cells, modify them to recognize disease, and return them to the body. Some have transformed treatment options for blood cancers. Yet producing these therapies is far more complicated than manufacturing conventional medicines. Each patient may require a carefully controlled process involving cell collection, modification, expansion, testing, and delivery.
The science has advanced rapidly. Manufacturing has struggled to keep pace.
Cellares, founded in 2019 in South San Francisco, was established to address that industrial challenge. Gerlinghaus brought experience in engineering and bioprocessing technology, while co-founder and president Omar Kurdi contributed operational expertise in manufacturing equipment and life-sciences businesses. Together, they built a company around the belief that cell therapy production needs a fundamentally different infrastructure.
Their ambition is not to discover a new cancer drug. It is to build the manufacturing systems that could help existing and future cell therapies become more consistently available.
Turning A Laboratory Process Into An Industrial System
Traditional cell therapy manufacturing can involve numerous separate instruments, manual interventions, and specialized operators. Moving a process between facilities can also require extensive technical work to demonstrate that the resulting therapy remains comparable.
Cellares is developing an integrated alternative. Its Cell Shuttle platform combines multiple manufacturing operations within a closed, automated system. The company describes it as a high-throughput platform designed for cell therapy production under current good manufacturing practice requirements.
The objective is to reduce dependence on manual handling while standardizing how manufacturing steps are executed and recorded. Automation may help reduce operational variability, improve traceability, and make production capacity easier to expand. However, the system must still demonstrate that it can consistently deliver products meeting the required quality standards.
Cellares also developed Cell Q, an automated quality-control platform for cell therapies. Manufacturing alone is not enough: each batch requires testing and release processes appropriate to the therapy. Integrating production and quality-control technologies is intended to create a more connected manufacturing operation.
The Manufacturing Challenge
– Complex Processes: Cell therapies require multiple coordinated steps involving sensitive biological material.
– Manual Operations: Traditional production can depend heavily on specialist operators and hands-on procedures.
– Quality Assurance: Every batch must meet stringent manufacturing and testing requirements.
– Capacity: Treatments must be produced in sufficient quantities without compromising product quality.
– Consistency Across Sites: Manufacturing processes need to remain comparable as production expands geographically.
A Factory Designed Around Living Medicines
Cellares calls its operating model an Integrated Development and Manufacturing Organization, or IDMO. The model combines process development, automated manufacturing, quality control, and digital infrastructure rather than treating them as separate services.
Its facilities are intended to help biotechnology companies translate their cell therapy processes onto automated equipment and then manufacture clinical or commercial supplies. The company’s smart-factory strategy includes sites in South San Francisco and Bridgewater, New Jersey, with planned international capacity in Europe and Japan.
The industrial ambition is considerable. Cell therapies have often been constrained by production costs, complex logistics, and limited manufacturing capacity. A more automated model could help manufacturers increase throughput and reduce some of the labour and facility demands associated with conventional operations.
But scale is not simply a matter of installing more equipment. Each therapy has its own biology, process requirements, and quality specifications. Automation must preserve the characteristics that make a treatment effective, while regulatory requirements must be satisfied at every stage.
That is why Cellares’s engineering proposition must ultimately be judged by manufacturing performance, not the sophistication of its machinery alone.
The CEO’s Challenge: Proving The Model In Practice
For Gerlinghaus, the company’s engineering ambition has always been connected to patient access. A therapy that works in clinical trials cannot help a broader population if its manufacturing process remains difficult, expensive, or slow to reproduce.
Cellares has attracted pharmaceutical interest and pursued partnerships intended to support large-scale production. Yet its commercial path has also exposed the difficulty of moving an emerging manufacturing platform into established drug-production systems.
In August 2026, Bristol Myers Squibb ended its agreement with Cellares concerning commercial-scale manufacturing for its CAR-T therapy Breyanzi. The companies disagreed over whether the Cell Shuttle could meet the programme’s commercial manufacturing requirements. Cellares maintained that its platform had produced a compliant therapy in an FDA-regulated clinical programme. The company subsequently announced workforce reductions at its South San Francisco operation.
The development is a significant test for Cellares. It highlights the distinction between demonstrating an automated process in clinical manufacturing and satisfying the demanding requirements of commercial production for a particular medicine. The setback does not, by itself, establish that the platform cannot work for other therapies or programmes. It does underline how much technical validation and customer confidence matter in this sector.
Manufacturing As A Patient-Access Issue
Cellares occupies an unusual position in healthcare. It does not directly treat patients, prescribe medicines, or develop the therapeutic molecules themselves. Instead, it is attempting to solve a bottleneck that can determine whether advanced treatments reach patients at meaningful scale.
That makes manufacturing a clinical-access question as much as an industrial one. Reliable production, quality assurance, and capacity influence how quickly a therapy can be supplied and how many patients can receive it.
The company’s longer-term opportunity depends on demonstrating that its integrated model can satisfy the needs of different cell therapies, customers, and regulatory environments. Its smart factories and automation systems represent an ambitious attempt to build that capability.
For Gerlinghaus and Cellares, the central task is now practical: translate engineering promise into repeatable commercial performance. If the company can establish that reliability across programmes, it could help create a stronger manufacturing foundation for cell therapies. If it cannot, the limitations will be as consequential as the technology’s potential.
The story of Cellares is therefore not simply one of automation entering biotechnology. It is about whether the infrastructure behind advanced medicine can evolve quickly enough to support the treatments science is beginning to make possible.
