Scaling CGT Capacity for a Growing Pipeline: Current Progress and Ongoing Hurdles

The mid- to late-stage cell and gene therapy (CGT) pipeline continues to show strong momentum. While established modalities, such as chimeric antigen receptor (CAR) T-cell therapies, continue to show efficacy and positive outcomes for patients with cancer, we are also witnessing an expansion of CGTs into new therapeutic areas with growing patient populations, such as Parkinson disease and diabetes.¹

Realizing the potential impact of this scientific progress will require the biopharmaceutical industry to significantly expand its manufacturing and value chain capacity. While emerging technologies and process innovations are streamlining production and administration, CGT complexity demands precise coordination across the entire value chain to help ensure these sensitive therapies continue to safely reach the patients who need them.

Moreover, the unique challenges associated with CGT delivery are inextricably tied to cost. Costs along the value chain impact each stakeholder: manufacturers invest in research and production; providers handle treatment equipment and administration; and payers manage high upfront costs while balancing the need for expanding patient access. To address the many factors impacting the cost of CGTs, the industry must continue to explore pricing models that more accurately reflect the comprehensive value of CGTs, particularly as policymakers adjust safety and administrative protocols based on clinical evidence.

The personalized and specialized processes involved in CGT production introduce a unique set of infrastructure, logistical, and administrative challenges—particularly at scale. However, manufacturers are making strides to address these hurdles through innovative automation technology and decentralized models.

For example, with autologous CGTs, the manufacturing of each dose requires each patient’s cells to be collected, modified, and reintroduced back into the body. This sophisticated process entails tightly coordinated logistics and the use of specialized transportation equipment between the laboratories and apheresis centers. To address this challenge, rather than relying on centralized production sites, the industry is moving toward smaller, digitally connected, more decentralized manufacturing hubs that are located closer to hospitals. This approach can streamline logistics and reduce turnaround times.

Another well-known example is Ori Biotech’s launch of a manufacturing platform, IRO, which automates the most manually intensive aspects of scaling up CGT manufacturing including activation, transduction, expansion, and cell harvesting. With this new platform, Ori Biotech is able to reduce labor needs by as much as 70% and reduce costs by as much as half,² while allowing digital synchronization through the cloud to distributed production sites. 

This program demonstrates that by placing smaller, digitally connected hubs closer to major hospitals, biopharmaceutical companies can reduce vein-to-vein times and logistics hurdles that currently complicate the process of collecting a patient’s cells, shipping them to the manufacturer to be modified, and then shipping the drug back to the hospital.

“Ori Biotech is partnering with leading organizations in CGT technology, logistics, and manufacturing to deliver the next generation of cell therapies at scale—speeding time to clinic, increasing throughput, decreasing COGs and improving quality,” according to Jason C. Foster, CEO of Ori Biotech. “Recent technical and regulatory innovations, including the recent approval of decentralized manufacturing by the UK regulator, are allowing us to re-invent CGT manufacturing to help ensure these incredible products live up to both their clinical and commercial potential.”

In another example of industry progress, Gilead has reduced the turnaround time for its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) from 16 days to 14 days. This was made possible through a manufacturing modification granted by the US Food and Drug Administration’s (FDA), allowing for earlier final formulation without compromising safety or efficacy.³ This change is also an example of how collaboration between biopharmaceutical companies and government agencies can advance CGT access.

Closed-loop manufacturing offers another promising solution to streamline manual processes and helps ensure uniform quality in CGT development.⁴ These automated, digitally connected production systems isolate, expand, and formulate cells within an enclosed environment with minimal human involvement. Automating these processes can reduce human error and increase consistency between batches. At scale, this manufacturing approach could minimize batch failures and increase production speed.

However, even with these advancements, successful CGT delivery remains an incredibly complicated process that will require continued coordination between multiple stakeholders including manufacturers and providers.  

As new technology and processes drive CGT production at a larger scale, value chain coordination becomes increasingly critical. The transportation and storage of live cellular material require advanced cryogenic and ultra-low temperature storage, as well as deep expertise in ensuring optimal conditions and adherence to strict chain-of-custody, chain-of-condition, and chain-of-identity protocols. Narrow viability windows associated with most CGTs after thawing further necessitate precise alignment between manufacturing schedules, logistics, administration, and patient readiness. To navigate these coordination demands, biopharmaceutical and provider stakeholders need integrated digital platforms that offer real-time visibility into the status of every dose. These platforms must track patient-specific batches, manage the chain of identity to ensure the right cells go to the right patient, maintain the chain of custody to document who handles the product at every step, and control the chain of condition to verify that temperature and handling requirements are honored. Systems must also support benefit verification and prior authorization workflows with payers.

Successfully balancing cold-chain logistics, regulatory compliance, and end-to-end transparency will depend on collaborative relationships with commercialization partners who possess the technological infrastructure, specialized expertise, and robust digital tools to support meticulous planning and logistics needs of these life-saving therapies.

Balance has never been more critical as more providers deliver CGTs, scaling up from the current concentration in major academic hospitals to community settings. 

“Given the increasing emphasis on reaching communities where patients reside, the orchestration of just-in-time supply chains are getting longer and cold chain logistics are becoming more complex,” said Sanjay Srivastava, PhD, managing director and Cell & Gene Therapy Center of Excellence lead at Accenture. 

Sanjay also added that, “The CGT healthcare system is evolving to be more decentralized and horizontally integrated with community hospitals leaning on partners to augment their capabilities to safely deliver CGTs to patients. This decentralized system calls for new business models and the exchange of data and information, pushing the industry to once again unlearn and relearn crucial patient and cell/tissue journey orchestration principles.” 

While expanding manufacturing and value chain capacity is imperative to help ensure broad patient access to CGTs, one factor is impossible to ignore: cost. 

There is no doubt that the intricate, patient-specific nature of CGT production and delivery impacts their costs. In addition to decades of research investment, development, and clinical trials, biopharmaceutical companies are also investing in specialized facilities, technology, process development, transportation, and training. 

Fully capturing all of these direct, indirect, fixed, and variable costs-to-serve is no easy task. The novel science, sophisticated production processes, and unique treatment protocols associated with CGTs don’t easily fit with a health care system designed for pay-as-you-go drugs. Even so, addressing these costs is essential, particularly as the industry scales up CGT capacity to meet an expected increase in demand. 

To manage high upfront expenditures for single-dose treatments that promise lifelong benefits delivered over several years, many in the industry are shifting toward price-to-value models. These models are informed by extensive biopharmaceutical research on therapy value and take into consideration payer expectations and clinical, operational, and societal benefits assessed through clinical trial outcomes, market research, and real-world data.

Policy decisions are also expected to impact these valuations. For example, the FDA’s recent decision to eliminate the Risk Evaluation and Mitigation Strategy (REMS) requirements for CAR T-cell therapies signals growing confidence in the experience and expertise of providers to effectively identify and manage toxicities associated with these treatments.⁵ Additionally, this particular policy change reduces administration and inpatient stay requirements, potentially enabling more providers, from major academic hospitals to community settings, to become qualified sites of care. This shift could help free capacity in hospitals and clinics, while also allowing patients to return to their normal routines sooner, supporting both reduced costs and improved patient experiences.

To meet the scale and scope of CGT delivery, all industry stakeholders—including manufacturers, providers, payers, and regulators—must align around a shared operational and financial strategy. Manufacturing innovation must be paired with digital transformation that creates transparent value chains and cost frameworks that reflect more accurate therapy valuations. Collaboration is the key to overcoming persistent logistical and financial challenges as the CGT pipeline expands to address new and broader patient populations. 

Future installments in this series will explore geographic and financial barriers to CGT access, along with emerging solutions that aim to bridge the gap between breakthrough therapies and the patients who need them. 

1. Alliance for Regenerative Medicine. Q2 2025 Sector Snapshot. Published July 2025. Accessed August 25, 2025. https://alliancerm.org/sector-snapshot-q2-2025/ 
2. Ori Biotech. IRO product website. Accessed July 24, 2025. https://oribiotech.com/iro
3. Gilead Sciences, Inc. Kite receives U.S. FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta® CAR T-cell therapy. Press release. Published January 30, 2024. Accessed July 24, 2025. https://www.gilead.com/news/news-details/2024/kite-receives-us-fda-approval-of-manufacturing-process-change-resulting-in-reduced-median-turnaround-time-for-yescarta-car-t-cell-therapy
4. Gupta S. Closed-loop manufacturing is the cell therapy revolution we need. Cell & Gene. Published June 18, 2025. Accessed August 25, 2025. https://www.cellandgene.com/doc/closed-loop-manufacturing-is-the-cell-therapy-revolution-we-need-0001
5. FDA eliminates risk evaluation and mitigation strategies (REMS) for autologous chimeric antigen receptor CAR T cell immunotherapies. Press release. US Food & Drug Administration. Published June 27, 2025. Accessed August 25, 2025. https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor 

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