Scaling CGT Manufacturing With Confidence: A Digital Foundation Blueprint

Why Your Breakthrough Therapy Deserves Better Than Paper-Based Manufacturing

Cell and gene therapies (CGTs) are rewriting the rules of modern medicine. Treatments once deemed impossible are now saving lives, offering hope to patients with genetic disorders, cancers, and chronic diseases that traditional pharmaceuticals couldn't touch. These therapies represent the cutting edge of biomedical innovation.

Yet here's the paradox: while CGT manufacturing pushes the boundaries of what's scientifically possible, the processes supporting this work are often stuck in the past, relegated to paper-based workflows and manual solutions that simply can't scale.

If that sounds familiar, you're not alone. Many developers of CGTs and advanced therapy medicinal products (ATMPs) find themselves caught between groundbreaking science and outdated operational systems. But here's the good news: digital transformation for CGT manufacturing offers a clear path forward, and it's more accessible than you might think.

The Unique Complexity of CGT Manufacturing

Before we dive into solutions, let's acknowledge what makes CGT/ATMP manufacturing fundamentally different from traditional pharmaceutical production.

Unlike conventional drug manufacturing—where materials are uniform, processes are standardized, and production runs are repeatable—CGT manufacturers face a uniquely challenging landscape:

• Batch-of-one or ultra-low-volume workflows that demand precision at every step.
• High variability in raw materials, including donor and patient cells that differ batch to batch.
• Narrow stability windows and complex logistics that leave little room for error.
• Stringent chain-of-identity (COI) and chain-of-custody (COC) requirements where a single tracking mistake could compromise patient safety.
• Rapidly evolving regulatory expectations that require constant adaptation.

These aren't just operational inconveniences. They're fundamental challenges in CGT manufacturing that paper-based systems and siloed technologies weren't designed to handle. The result? Paper-based reviews that consume days in processes where minutes matter, manual data entry that introduces costly errors and rework, and disconnected systems that obscure visibility exactly when real-time oversight is most critical.

Want to understand how leading CGT manufacturers are overcoming these challenges? Download our industry brief: "Building a Scalable Digital Foundation to Support CGT Manufacturing."

Digital Transformation Is No Longer Optional

Building a digital foundation for CGT manufacturing isn't just about staying competitive or streamlining operations. It's about fundamentally enabling your ability to scale life-saving therapies.

A strong digital foundation doesn't eliminate the inherent complexity of advanced therapies, but it controls what can be controlled. It creates the infrastructure needed to scale confidently—from early clinical batches to commercial production and beyond.

For CGT and ATMP manufacturing, digital transformation at scale has moved from "nice to have" to absolutely essential. Organizations that delay this transition risk falling behind not just operationally, but in their ability to bring therapies to the patients who need them.

Discover the practical roadmap for digital maturity in our comprehensive industry brief.

There's a Roadmap (And It Meets You Where You Are)

Here's what many CGT/ATMP developers don't realize: enterprise digital transformation doesn't require ripping out your entire operational infrastructure and starting from scratch.

The path to digital maturity follows a predictable progression—from establishing the basics to achieving full end-to-end orchestration. The key is understanding where you are in that digitization journey and taking the right next step, not trying to leap to the finish line.

Whether you're an early-phase developer working with small teams and limited budgets, or a commercial-scale manufacturer managing global operations, there's a practical approach designed for your current reality.

Early-Phase: Building the Foundation

Early-stage CGT developers don't need to implement everything at once. The goal is to put the right structures in place so:

• Operators work from a single source of truth.
• Data is captured cleanly at the point of execution.
• Processes can accommodate inevitable variation.

This foundation becomes critical as you scale.

Growth-Phase: Scaling Without Breaking

As programs expand—more batches, shifts, production partners, etc.—the limitations of early digital decisions become visible. This is where manufacturers need to evolve from basic digitization to connected systems that support growth without constant rework.

Commercial-Scale: Full Orchestration

Commercial production operates under intense pressure: compressed timelines, global operations, expanding teams, and increased regulatory oversight. At this stage, large scale digital transformation means evolving from isolated integrations to a fully connected ecosystem where data flows seamlessly and insights drive real-time decisions.

Our industry brief provides a detailed framework for navigating each of these phases, complete with practical considerations for technology selection, implementation strategy, and change management.

The Business Case: Measurable Benefits That Matter

Digital transformation in CGT manufacturing isn't just about modernization—it delivers concrete, measurable outcomes that impact your bottom line and your ability to serve patients.

Organizations that successfully build mature, connected systems can expect:

1. Faster Batch Review and Release

When data is captured at the time of execution and quality teams have real-time visibility, CGT batch review cycles shrink dramatically.

2. Fewer Deviations

Enforced standard operating procedures (SOPs), in-line quality checks, and elimination of manual data entry reduce errors and the costly investigations that follow.

3. Improved Tech Transfer Readiness

Structured, standardized data makes it exponentially easier to transfer CGT processes across facilities or to contract development and manufacturing organizations (CDMOs).

4. Stronger Cross-Functional Collaboration

Shared visibility across manufacturing, quality control (QC), quality assurance (QA), and supply chain teams eliminates silos and enables more informed decision-making.

5. Increased Audit Readiness

Unified, traceable data across your entire process means you're always inspection-ready rather than scrambling to compile documentation when auditors arrive.

These aren't theoretical benefits. They're the outcomes that advanced therapy manufacturers are achieving right now by following a structured approach to digital maturity.

Learn the specific strategies for achieving these outcomes—download the full industry brief.

Looking Ahead: The Decentralized Manufacturing Future

As if the current challenges weren't enough, the advanced therapies sector is rapidly moving toward its next frontier: decentralized, patient-proximate manufacturing.

This evolution promises to transform treatment delivery by reducing vein-to-vein time and expanding access beyond major academic medical centers. It removes geographical barriers that currently limit who can receive potentially life-saving therapies.

The reality, however, is that decentralized manufacturing will only work at scale if your digital foundation is already solid. You can't distribute your manufacturing footprint if your systems are siloed, your data is trapped in paper, and your visibility is limited to a single facility.

The organizations that are building robust digital foundations today aren't just solving current operational challenges—they're positioning themselves for the future of advanced therapies delivery.

Your Next Step Forward

Building a scalable digital foundation for CGT manufacturing is a journey, not a destination. It requires careful planning, the right technology partners, and a clear understanding of where you are and where you need to go.

The good news? You don't have to figure it out alone.

Our industry brief, "Building a Scalable Digital Foundation to Support CGT Manufacturing," provides:

• A detailed, phase-by-phase roadmap for digital maturity.
• Practical guidance on technology selection and implementation.
• Real-world considerations for organizations at every stage.
• Strategic insights to help you avoid common pitfalls.
• A framework for building systems that scale with your growth.

Whether you're just beginning your digital transformation or looking to mature your existing systems, this guide offers actionable strategies designed specifically for the unique challenges of CGT and ATMP manufacturing.

Download the complete industry brief now and discover how to build the digital foundation your breakthrough therapy deserves.