Cell & Gene Therapy: 4 Cross-Industry Lessons for Commercial Success

Ex-vivo cell and gene therapies—where a patient's own cells are collected, modified, and returned to fight and often cure, disease—have the potential to transform healthcare. Unfortunately, commercial scale pharmaceutical models and capabilities weren't built for this level of personalization or operational complexity. 

What if solutions to this problem already exist? While biopharma organizations have focused on scientific innovation, others have discovered innovative methods for delivering high quality products quickly, affordably, and at scale. Lessons from four unexpected industries could provide cell & gene therapy developers with a pathway to address their core operational challenges, ultimately helping bring lifechanging treatments to more patients who need them. Let’s take a closer look. 

4 operational challenges for ex-vivo cell & gene therapies

Commercialization and growing pipelines drive new scope, scale, and complexity to the core challenges of ex-vivo cell therapies.

Bridging the gap between scientific breakthrough and commercial viability requires strategic action early in the cell therapy lifecycle. By tackling core business challenges now, cell therapy organizations are better positioned to deliver life-changing treatments at scale. Those that wait face the risk of commercial failure and an inability to unlock the promise of cell and gene therapies. 

Challenge 1: Vein-to-vein turnaround time 
Unlike traditional biologics, ex-vivo therapies require a make-to-order supply chain. This results in an often-lengthy vein-to-vein turnaround time, from apheresis to therapy infusion, spanning weeks or even months. Patients must sometimes pause other treatments while awaiting infusion—resulting in disease progression or complications from comorbidities—deterring some physicians from prescribing these therapies.

Challenge 2: Unsustainable costs 
The prohibitively high per patient cost of single-use equipment, vector, materials, labor, and logistics—and associated cost to payers—limits reimbursement, profitability, and patient access. 

Challenge 3: Rapidly scaling vs. quality 
Demand for cell therapies is growing rapidly. However, scale-ups necessitate more capacity than traditional biologics—from two to 20 times more staff, sites, and equipment—straining quality systems and operational efficiency. An out-of-spec or non-conforming batch could mean hundreds of thousands to millions in lost revenue and require drawing more cells from already vulnerable patients. 

Challenge 4: Disconnected and reactive operating models 
Many cell therapy supply chains lack mature end-to-end processes or integrated technology. Legacy R&D operating models persist, resulting in disconnected operations and high variability. Moving to a proactive, commercially oriented model and behaviors that elevate focus on speed, cost, quality, and scalability are crucial to support commercial viability. 

Zooming in: 4 cross-industry lessons for cell and gene therapies 

Leading organizations across the following four industries have overcome challenges similar to those currently impeding ex-vivo cell and gene developers. Their solutions offer valuable insights—here are four proven cross-industry approaches that merit consideration: 

Retail & CPG: Creating a transparent collaborative ecosystem 

The retail and CPG industries reveal the power of integrated partnerships, particularly in managing complex, multi-stakeholder supply chains. CPG giants like P&G, J&J (now Kenvue), and Unilever have revolutionized their external operations by creating deep collaborations with retail partners like Walmart and Walgreens. These high scale, high velocity, supply chain partners are leaning into transparent collaboration by sharing everything from business plans and sales forecasts to production schedules.  

The result? Trust, transparency, process/metric alignment, digital integration, and an effective customer-centric approach.  

The opportunity for cell therapy:  

CPFR creates end-to-end visibility and synergy across supply chain partners, optimizing cycle times, reducing stockouts, and unlocking significant cost efficiencies. 

Cell and gene therapies rely on a multitude of partners—hospital networks, contract manufacturers, suppliers, and specialty couriers, to name a few. By collaboratively sharing everything that matters and aligning their strategic and operational plans, they can build a more responsive, integrated, and extended supply chain that continuously improves over time. 

Automotive Services: Orchestrating complex workflows with precision

The automotive services industry shows us what's possible when we apply smart prediction to complex operations. NAPA, for example, has found a way to deliver “all the right parts, in all the right places”. The company has achieved this by using sophisticated analytics to manage more than 100,000 unique parts across thousands of locations, drawing insights from every possible source including vehicle registrations, traffic patterns, and purchase histories. 

Downstream, top Nissan service centers employ AI and automation to synchronize parts, labor, service bay, and loaner car availability with scheduled and forecasted maintenance needs. This streamlines operations, minimizing downtime and optimizing customer experience—a critical lesson for any industry managing complex workflows at scale. 

The opportunity for cell therapy: 

Combining and adapting these practices for cell therapy ensures materials—like vector, raw materials, and finished CAR-T—arrive precisely when and where they’re needed. That is, synchronized with manufacturing slot capacity, hospital bed availability, and patient demand to optimize turnaround time, patient experience, and outcomes while eliminating waste. 

Agriculture: Achieving near-perfect quality assurance

AI is raising the bar for precision, speed, and consistency in quality control. John Deere’s AI and machine vision cameras have been able to detect welding defects with up to 97 percent accuracy. Tractor Supply has similarly leveraged AI and machine vision technology to record, classify, and verify package contents before they leave the warehouse, ensuring quality and accuracy in every step. 

The opportunity for cell therapy: 

The typical benchmark for human visual inspection is about 80 percent of defects caught per batch–machine learning algorithms can outperform visual inspection by identifying defects with 99 percent accuracy. This significantly reduces human error, manual labor and rework costs. 

Precision, consistency, speed, and building trust in processes that cannot afford mistakes is critical for ex-vivo therapies, where the stakes are higher, but the opportunities are even greater. AI-enabled vision systems and data monitoring can: 

• Detect operator errors in real time. 
• Review batch records for inconsistencies.  
• Flag equipment defects before they impact product quality. 
• Verify chain of custody/identity.

AI vision systems have the power to transform quality management in cell therapy by reducing the margin of error to near zero. This means organizations can not only improve quality but also accelerate turnaround and meet stringent regulatory standards with confidence.

Fashion: Scaling personalization through modular manufacturing

The fashion industry's use of modular manufacturing brings unexpected insights for cell therapy production. Zara predefines a core set of fabrics, colors, and patterns that can be used across multiple product lines. This modular approach enables Zara to produce a wide variety of styles by simply mixing and matching standard components. Upon detecting a trending style, Zara can also immediately react. Nike has taken a similar tactic by utilizing standard and preassembled shoe outsoles, midsoles, and uppers for its make-to-order shoes, that can be customized later in the process. This modular approach enables efficiency by focusing on final-stage customization rather than making every shoe from scratch. 

The opportunity for cell therapy: 

These apparel manufacturers demonstrate how modular manufacturing strategies can minimize production cycle times, reduce waste, rapidly pivot product offerings, and enable personalization at scale. 

Ex-vivo therapy manufacturers should be adopting these same principles in two ways: 

1. Standardizing and kitting/pre-assembling components like tailored assemblies of consumables and reagents.  
2. Using scalable and modular manufacturing platforms, especially those capable of supporting multiple cell therapy modalities as pipelines evolve (e.g. Autologous and Allogeneic; CAR-T, TCR, TIL, or Treg). 

This approach reduces vein-to-vein turnaround time, with the added benefit of faster speed to market for therapies when they use common components. It is worth mentioning however, that strict regulatory requirements around manufacturing changes mean companies need to plan this strategy early in the development lifecycle to avoid additional regulatory submissions and costly revalidations.

Art of the possible: Agentic AI enabled supply chain orchestration

The next leap forward in simplifying operational complexity at scale is already emerging: Agentic AI. By combining deep learning with autonomous decision-making capabilities, organizations can create closed-loop feedback systems that adapt in response to changing variables, with balanced decision rights between humans and AI.

These intelligent systems continuously monitor: 

• Real-time data (point-of-sale data, temperature, pH, location). 
• Historical data (forecast accuracy, cycle times, deviations, out-of-spec). 
• Contextual information (chain of identity)

They then predict potential issues and dynamically adjust operational plans—with balanced human-machine decision rights—to meet changing conditions and optimize outcomes. In practice, this could mean: 

• Detecting anomalous changes, patterns, and correlations as they relate to inventory, capacity, metrics, and key batch parameters.  
• Alerting supply chain and technical operations leaders to potential equipment defects, deviations, and capacity constraints before they occur. 
• Dynamically adjusting apheresis, manufacturing, or infusion slots when there is a capacity constraint, expected inventory shortage, or allocated equipment defect detected.  
• Rapidly rerouting cryogenic shipments to different lanes or specialty couriers, based on performance, traffic, or weather patterns. 

The results include faster vein-to-vein turnaround times, fewer out-of-spec batches, and supply chain agility, giving organizations the foundation they need to scale quickly while maintaining product quality and patient safety.  

Zooming Out: The power of a unified vision in cell therapy delivery 

Cross-industry best practices and agentic AI provide powerful tactical solutions, but it’s critical to apply them in a way that is holistic and rooted in the cross-organizational context. Many fall into the trap of chasing individual use cases; implementing isolated technology solutions or process improvements without considering the broader ecosystem. This piecemeal approach often leads to: 

• Technical and operational debt that compounds over time 
• Siloed improvements that create new bottlenecks elsewhere in the value chain 
• Limited ROI as tactical solutions fail to address systemic challenges 
• Change fatigue as teams implement multiple disconnected initiatives 

By zooming out to see the complete picture before zooming in on specific use cases, like quality assurance or modular manufacturing, cell and gene therapy manufacturers can: 

• Develop an integrated end-to-end strategy that considers the entire ecosystem from patient identification to post-treatment monitoring 
• Create a capability roadmap that sequences improvements for maximum impact 
• Establish governance structures that break down silos between technical, clinical, and operational teams 
• Build shared metrics that measure collective success rather than functional excellence 

This zoomed-out, context-driven approach allows for true step-change improvements like accelerating time-to-market, reducing costs, and ultimately, delivering more life-saving treatments. 

Making the promise of ex-vivo cell and gene therapies a reality 

Ex-vivo cell and gene therapies have proven their power to transform patient outcomes, but realizing their full potential requires more than clinical efficacy. Fresh operational strategies are key to unlocking commercial viability. By learning from industries that have mastered complexity at scale—such as through collaborative partnerships, modular manufacturing, and AI-driven orchestration—biopharma organizations can: 

• Accelerate vein-to-vein turnaround time for improved patient outcomes and competitive advantage. 
• Improve operational consistency and quality, to reduce quality bottlenecks, deviations, out-of-spec and non-conforming batches. 
• Lower COGS to increase patient access, price competitively, and ensure favorable reimbursement. 
• Scale rapidly to meet rising demand without compromising quality. 

The next few years will reveal which organizations can turn cell & gene therapy’s promise into reality. Those with the greatest impact will be the ones who can combine breakthrough clinical success with supply chain and operational mastery, to deliver life-changing treatments faster, more affordably, and at scale.