Building Quality at the Source: Overcoming CGT-Specific GMP Challenges

Quality testing and batch release consumes up to 70% of manufacturing lead time.¹ For cell and gene therapies (CGT) where a child's morning blood draw transforms into a life-saving cell therapy by nightfall, there's no room for quality as an afterthought.

When Every Batch Matters: The Unique Quality Landscape of CGT

Unlike traditional pharmaceuticals with their million-tablet production runs, CGT manufacturing often means creating individualized "batch-of-one" therapies that cannot fail. And that changes everything.

What makes CGT quality management so uniquely challenging?

• Personalized production models where each patient equals one batch.
• Starting material variability that changes with every donor or patient.
• Rapid turnaround requirements where hours, not days, matter.
• Multiple manual touchpoints, each creating opportunities for error.
• Complex chains of identity that must remain unbroken.

Industry research featured in "The Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing" reveals the stark reality behind these challenges — manual processes, disconnected instruments, and non-standardized paper documentation create bottlenecks throughout the quality process.

Transform your quality timelines: Download the Ultimate Guide to learn how leading CGT manufacturers cut review times by 75%.

Navigating the Regulatory Maze Without Getting Lost

The regulatory landscape for CGT products isn't just complex—it's evolving in real-time alongside the science. Since 2017, both FDA and EMA have released waves of new guidance documents specifically for cell and gene therapies.

The Compliance Conundrum

The hard truth? Regulatory expectations don't scale down for batch-of-one production. Whether you're making one dose or thousands, CGT companies must satisfy the same GMP certification requirements by maintaining:

1. Meticulous record keeping.
2. Qualified personnel documentation.
3. Stringent sanitation protocols.
4. Equipment verification.
5. Process validation.
6. Complaint handling.

For emerging CGT innovators, especially those transitioning from breakthrough science to commercial manufacturing, this regulatory gauntlet can feel overwhelming.

When Quality Falls Through the Cracks: A Wake-Up Call

Need proof of what happens when quality becomes secondary? In 2023, a global pharmaceutical company received an FDA Form 483 citing "significant" production problems with its flagship CAR-T therapy.² Some of the issues cited included:

• Inadequate contamination prevention procedures.
• Insufficient production controls.
• Failing systems to prevent mix-ups.
• Substandard laboratory controls.

Even more concerning? Nearly 100 possible contamination instances over four years in their production area. For patients depending on these therapies, these aren't just compliance issues—they're potential life-altering failures.

Don't become a cautionary tale: Download the Ultimate Guide to see how digital solutions reduce deviations by 25%.

Quality at the Source: Reimagining CGT Manufacturing

Building quality at the source isn't about more inspections—it's about preventing errors before they happen. For CGT manufacturers, this means fundamentally rethinking how quality integrates with production by undertaking four key initiatives.

1. Breaking Free from the Documentation Burden

Did you know? Nearly one-third of CGT staff time disappears into documentation. Paper-based batch records—often thousands of pages long—create a perfect storm with inefficiencies like:

• Teams relying on potentially outdated standard operating procedures (SOPs).
• No real-time visibility into changes or quality events.
• Document reviews becoming dragged-out logistical nightmares.
• Missing or incorrect batch information causing release delays.

Modern cell and gene therapy software eliminates these bottlenecks, generating and checking records automatically. Right first time, right on time.

2. Creating Real-Time Quality Intelligence

Imagine connecting every aspect of your production environment—operators, equipment, materials, and processes—into a single source of truth. Digital connectivity within a unified platform makes this possible by:

• Capturing data directly at the source.
• Integrating seamlessly with enterprise systems.
• Managing deviations in real-time.
• Automating training verification.
• Ensuring equipment compliance.
• Connecting stakeholders across sites.

When quality data flows freely throughout your organization, decisions about nonconformances and corrective actions/preventive actions (CAPAs) happen faster and are backed by up-to-date data.

3. Deploying Manufacturing Systems Built for CGT

Traditional manufacturing execution systems weren't designed for the unique realities of cell and gene therapy production. Purpose-built solutions deliver:

• Flexibility for batch-of-one workflows.
• Support for operator-centric processes.
• Unbreakable chain-of-identity tracking.
• Seamless quality management integration.
• Real-time monitoring capabilities.

Industry leaders implementing these modern MES systems report batch review and release times accelerated by 75%-80%.³ That directly translates to patients getting treatment faster with products that maintain the highest quality standards.

4. Connecting the Dots for GMP Compliance

Digital connectivity doesn't just streamline operations—it transforms good manufacturing practice (GMP) compliance from a burden into a competitive advantage through:

• Continuous monitoring and real-time feedback.
• Digitalized documentation that eliminates paper-based errors.
• End-to-end traceability across the production lifecycle.
• Proactive deviation management.
• Virtual audit readiness.
• Secure data sharing across collaborators.
• Greater visibility into complex supply chains.

See how digital technologies reduced data integrity errors by 90% in CGT manufacturing: Download the Ultimate Guide.

Data-Driven Quality: The New Competitive Edge

In an industry where quality directly impacts patient outcomes, data-driven insights aren't just nice to have—they're essential. Modern CGT quality management systems deliver:

• Complete visibility into manufacturing processes.
• Accelerated release through review-by-exception.
• Standardized processes that scale across sites.
• Advanced analytics that fuel continuous improvement.
• Simplified validation using risk-based approaches.
• Flexible templates for diverse product specifications.
• Unified data that drives better decision-making.

From Quality Control to Quality by Design

For cell and gene therapy manufacturers, the shift from quality as inspection to quality by design represents more than compliance—it's the path to commercial success. By embedding quality into every step through digital transformation, CGT innovators:

• Speed therapies to patients without safety compromises.
• Drive down cost of goods sold (COGS) through right-first-time execution.
• Create digital data integrity that satisfies regulators.
• Scale operations while maintaining consistent quality.
• Adapt quickly as regulations evolve.

The journey from promising CGT science to commercial therapy requires more than groundbreaking biology—it demands quality systems as innovative as the treatments themselves.

Ready to revolutionize your approach to CGT quality? Download The Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing today.

References:

1. "Dare to be Different: It's Time to Revamp Collaboration in Life Sciences Contract Manufacturing," Accenture Life Sciences.
2. "Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls," Fraiser Kansteiner, Fierce Pharma, Dec. 7, 2023.
3. "The Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing," MasterControl, 2025.