Navigating GMP Certification in Cell and Gene Therapy Manufacturing: The Digital Advantage

A child's blood draw in the morning can become a lifesaving cell therapy by nightfall—but only if manufacturing can keep pace. With the cell and gene therapy (CGT) market projected to expand from \$21.28 billion to \$177.46 billion by 2034 at an 18.7% compound annual growth rate¹, your manufacturing processes need to evolve just as rapidly as your science.

Breaking Through the Regulatory Maze

CGT and advanced therapy medicinal product (ATMP) regulatory frameworks aren't just complex—they're constantly evolving. Since 2017, both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have released a flurry of new guidelines, creating a regulatory landscape that's shifting beneath our feet.

"With hundreds more (cell and gene therapies) in the clinical pipeline, a need for better process automation arises to enable scalable manufacturing, as well as cost and complexity reduction," says Rohin Krishnan Iyer, senior director of cell and gene operations at Marken.²

This complexity isn't just about paperwork. It's about patients. When you're manufacturing autologous therapies where each patient's cells serve as the foundation, you're not just managing batch records—you're managing lives.

Download our Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing to see how innovators are conquering compliance challenges.

GMP in the Age of Personalized Medicine

Your traditional GMP playbook? It needs a rewrite. The core requirements remain:

• Record keeping.
• Personnel qualifications.
• Sanitation.
• Equipment verification.
• Process validation.
• Complaint handling.

But CGT manufacturing brings unique twists that alter how these standards apply. Consider the following four unique attributes of CGT:

1. Every Batch Is Personal

Working with living cells means inherent batch-to-batch variability. Your documentation systems need flexibility without sacrificing compliance.

2. Speed Equals Success

When you're working with autologous therapies, time isn't just money—it's efficacy. Documentation errors that delay release don't just affect the bottom line. They directly impact treatment windows.

3. Identity Is Everything

Mix-ups aren't just quality events—they're potential tragedies. Manual tracking creates opportunities for errors your patients can't afford.

4. Scaling Is Survival

According to research highlighted in our CGT guide, 40% of advanced therapy executives aren't confident they can meet demand over the next three years.³ That confirms that your manufacturing approach needs to grow with your pipeline.

Paper: The Hidden Compliance Killer

Let's be honest: paper-based processes are holding you back. Consider these realities:

• Manual documentation tasks achieve only 91% accuracy.
• Quality testing and batch release consume up to 70% of manufacturing lead time.
• Nearly one-third of staff time gets swallowed by documentation.⁴

When your batch records span hundreds or thousands of pages, is it any wonder compliance feels like climbing a mountain?

Cut batch review time by 75% with modern digital systems—learn how in our Ultimate Guide.

Digital Transformation: Quality From the Start

Rather than just implementing digital systems, smart CGT and ATMP manufacturers are reinventing how quality happens.

Electronic Batch Records That Work for You

Modern electronic batch records (EBRs) don't just replace paper. They optimize your approach production and catch errors in real-time, not during post-production reviews when it's too late to prevent issues.

"Quality at the Source" isn't just a catchphrase. It's the central tenet of EBRs' ability to embed compliance directly into workflows, eliminating the quality bottlenecks that slow patient treatment.

Connected Systems, Connected People

Your data shouldn't be trapped in silos. Modern CGT software connects your people, systems, and equipment to create a single source of truth. This means:

• Real-time production intelligence at everyone's fingertips.
• Immediate deviation management when things go off track.
• End-to-end traceability from donation to administration.
• Automated validation that keeps equipment ready when you need it.

It's true that digital connectivity facilitates regulators' satisfaction, but it also transforms how your entire team approaches quality.

Real-World Consequences of Paper Dependence

The stakes couldn't be higher in today's highly technical, fast-paced, and ultra-competitive CGT market. In 2023, the FDA issued a Form 483 to a global pharmaceutical company for "significant" problems with its flagship CAR-T therapy.⁵ The observations included:

• Inadequate contamination prevention procedures.
• Insufficient production controls.
• Failure to establish proper laboratory standards.

Over four years, the company also logged approximately 100 possible contamination instances in the production area. These types of compliance issues have the potential to alter the lives and well-being of patients waiting for treatment.

Measurable Results That Matter

When CGT manufacturers implement comprehensive digital platforms, the improvements aren't theoretical—they're transformative:

• 75% reduction in batch review time means therapies reach patients faster.
• 90% decrease in data integrity errors strengthens confidence in every batch.
• 25% fewer deviations means more predictable manufacturing outcomes.

These are more than just metrics. They're the difference between treatments that arrive on time and those that don't.

Discover the exact methods leading CGT manufacturers use to achieve these results.

Building Your Digital Compliance Strategy

Ready to transform your approach to GMP? Here's are five key elements to prioritize:

1. Connected Systems

Siloed data creates siloed thinking. Choose solutions that seamlessly link with your learning information management systems (LIMS), enterprise resource planning (ERP) systems, and other manufacturing systems in your existing tech stack.

2. Flexibility for Small-Batch Excellence

Your system should handle one-patient batches with the same rigor as larger runs—without excess complexity.

3. Cloud-First Architecture

Enable your teams to collaborate seamlessly across sites and share data instantly where it's needed most.

4. Streamlined Validation

Look for solutions that minimize validation overhead without cutting corners on compliance.

5. Intelligence, Not Just Automation

Smart systems should help you identify exceptions, not force you to review every detail of every record.

Changing Everything

The cell and gene therapy revolution isn't just happening in labs—it's happening in manufacturing suites. As your therapies grow more sophisticated, your approach to GMP compliance needs to keep pace.

Digital transformation is about more than efficiency. It's about fulfilling the promise your therapies offer to patients who are waiting. By connecting systems, automating documentation, and building quality directly into processes, you're not just improving compliance—you're accelerating innovation.

As noted in The Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing, "By autopopulating reports with relevant information, generative AI can streamline documentation and provide consistency and compliance with quality standards."

Ready to transform your CGT manufacturing? Download our Ultimate Guide today.

References:

1. "Cell and Gene Therapy market Size, Share and Trends 2025 to 2034," Precedence Research, July 14, 2025.
2. "2025 cell and gene challenges: Scalability, supply chain and manufacturing," Karen Langhauser, Cell & Gene Therapy Review, Feb. 3, 2025.
3. "2024 advanced therapy industry report," Deloitte.
4. "The Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing," MasterControl, 2025.
5. "Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls," Fraiser Kansteiner, Fierce Pharma, Dec. 7, 2023.