Shifting Ground
How In Vivo CAR-T Will Reshape Laboratory and Cancer Center Planning
The distant future has a way of arriving faster than expected. While ex vivo CAR-T therapy has dominated oncology research and commercialization for the past decade, a new paradigm is emerging. In vivo CAR-T—once a purely experimental concept—has begun transitioning from preclinical models into early-phase human trials. Since initial demonstrations of in vivo CAR-T generation in the late 2010s, a growing cohort of platforms developed by companies such as Umoja Biopharma, Interius BioTherapeutics, and Capstan Therapeutics has entered Phase 1 studies.
Although these therapies remain far from regulatory approval, their potential advantages are structurally significant. By eliminating patient-specific manufacturing, in vivo approaches offer a fundamentally different model—one defined by reduced production complexity, shorter lead times, and the possibility of broader patient access. These characteristics have positioned in vivo CAR-T as an increasingly attractive frontier, drawing investment from both established CAR-T leaders and emerging biotechnology platforms alike.
Infrastructure Implications for Labs and Cancer Centers
As in vivo CAR-T therapies move toward broader clinical adoption, capital project planning and operational strategies for pharmaceutical laboratories and hospital cancer centers are likely to undergo a paradigm shift. Unlike ex vivo therapies—a multi-step process spanning leukapheresis, genetic modification, expansion, lymphodepletion, and infusion, often requiring several weeks—in vivo therapies can be administered based on patient readiness rather than manufacturing timelines. Ex vivo treatments are produced on demand; in vivo therapies introduce the possibility of an off-the-shelf model. In this context, a hub-and-spoke logistics system is likely to emerge as the dominant model for pharmaceutical companies, with centralized, high-throughput manufacturing hubs distributing to regional nodes for delivery to cancer care facilities.
Cancer care facilities will also undergo significant transformation, particularly within pharmacies and infusion centers. The “off-the-shelf” nature of in vivo therapies shifts the role of pharmacies from temporary custodians of patient-specific, time-sensitive products to managers of inventory that is no longer tied to individual patients. Unlike ex vivo therapies—some of which must be administered within hours of arrival—in vivo products enable pharmacies to maintain a limited, buffer supply aligned with patient scheduling. As a result, the streamlining observed in pharmaceutical manufacturing extends into oncology pharmacy operations, reducing logistical complexity through the removal of vein-to-vein tracking requirements associated with ex vivo therapies.
In infusion settings, the model of care shifts from idiosyncratic, high-acuity delivery to repeatable, lower-acuity care. Ex vivo therapies are typically administered as one-time, high-intensity treatments with extended infusion and monitoring periods. In contrast, in vivo therapies are expected to follow a repeatable, dose-flexible model with shorter infusion times. Patients may spend less time per visit but require more frequent infusions compared to the “one-and-done” approach of ex vivo therapies. For cancer centers focused on maximizing throughput, this shift may necessitate an increase in infusion bay capacity and associated staffing to accommodate higher patient volumes—particularly if reimbursement per treatment is lower than that of ex vivo therapies.
A System-Level Shift in Operating Models
The transition from ex vivo to in vivo CAR-T can be understood through a set of fundamental operational shifts that extend across manufacturing, logistics, and care delivery.
Ex vivo therapies operate within a case-based system: treatments are produced on demand, tied to individual patients, and delivered through tightly coordinated, time-sensitive workflows. In contrast, in vivo therapies introduce a throughput-oriented model, where standardized products can be manufactured at scale, distributed through established supply chains, and administered with greater flexibility. This shift is reflected across several key dimensions. Manufacturing moves from bespoke, small-batch production to platform-based, high-throughput processes. Logistics transitions from a closed-loop, vein-to-vein system to a hub-and-spoke distribution network. Clinically, care delivery evolves from one-time, high-acuity interventions to repeatable, lower-acuity treatment models. Together, these changes signal a broader transformation—from a system defined by individualized production and coordination to one characterized by scalability, standardization, and flow.
Designing for an Uncertain but Directional Future
Despite its promise, in vivo CAR-T remains in early clinical stages, and its ultimate role in oncology care is not yet fully defined. For planners and developers, this introduces a critical challenge: how to design infrastructure that is responsive to a potential paradigm shift without overcommitting to a model that has yet to mature.
In this context, flexibility becomes a central design principle. Laboratory environments may need to accommodate both patient-specific cell processing and emerging biologics manufacturing platforms. Similarly, cancer centers must balance current demand for high-acuity, scheduled infusion with the potential future need for higher-throughput, repeatable treatment capacity.
Rather than optimizing for a single anticipated future state, organizations should prioritize adaptable systems—modular GMP spaces, scalable infusion capacity, and right-sized cold storage infrastructure that can expand with demand. The goal is not to predict the precise trajectory of in vivo CAR-T, but to ensure that facilities remain resilient across multiple potential scenarios.
Preparing for the Next Phase of CAR-T Delivery
The evolution of CAR-T therapy from ex vivo to in vivo represents more than a scientific advancement—it signals a broader shift in how therapies are produced, delivered, and integrated into care systems. While the timeline for widespread adoption remains uncertain, the direction of change is increasingly clear.
For those involved in laboratory and healthcare facility planning, the implications are immediate. Decisions made today—regarding manufacturing space, infusion capacity, and operational models—will shape the ability to adapt to this next generation of therapies. As the field progresses, the most resilient organizations will be those that recognize the shift early and design not for the present alone, but for the system that is already beginning to emerge.