5 Digital Strategies That Reduce CGT Batch Review Time by 75%

Every minute spent on batch reviews is a minute a patient waits for their life-saving therapy. With quality testing and batch release consuming up to 70% of manufacturing lead time in the cell and gene therapy (CGT) industry¹, organizations can't afford outdated processes.

In the fast-paced world of cell and gene therapy, transforming groundbreaking research into commercial production isn't just challenging—it's a race against time. With the CGT market set to skyrocket from \$21.28 billion to \$177.46 billion by 2034 (that's an impressive 18.7% CAGR)², organizations face a critical reality: our current manufacturing capacity covers only 5%-10% of what we'll need for commercial scale in the next decade.

For CGT pioneers, one mantra matters above all: "Right First Time. Right On Time." When a child's morning blood draw must become a life-saving therapy by nightfall, there's no room for error or delay.

The CGT Manufacturing Challenge

The numbers tell the story about the obstacles CGT companies face. Despite hundreds of Investigational New Drug Applications flooding the FDA, just over 30 CGT products have crossed the finish line to approval.³ Looking deeper, 40% of advanced therapy executives aren't confident they can meet demand over the next three years.⁴ Need outsourced manufacturing? Get in line—most organizations face an 18-24 month wait for CDMO capacity.

These bottlenecks stem from unique CGT manufacturing challenges:

• Production Inconsistencies: Manual processes introduce variability when precision matters most.
• Documentation Burden: Batch records often stretch to hundreds of pages.
• Regulatory Complexity: Evolving frameworks add weeks or months to timelines.
• Quality Control Delays: Testing and batch release consume up to 70% of manufacturing lead time.

Manufacturing bottlenecks slowing your CGT production? Download our Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing and discover how to accelerate while maintaining compliance.

5 Digital Strategies for Faster Batch Reviews

Let's explore the five digital transformation strategies that leading CGT organizations are using to reduce batch review time by 75% while scaling operations.

1. Implement Digital Batch Records

Paper batch records can span hundreds—even thousands—of pages for CGT processes. By implementing digital batch records, organizations eliminate the documentation burden that consumes nearly one-third of staff time.

Digital records provide:

• Real-time data capture at the source.
• Automated calculations and verifications.
• Structured workflows that prevent missing information.
• Visibility throughout the batch production process.

As one manufacturing director from Dendreon shared after implementing cell and gene therapy quality manufacturing software, "We've really been able to cut [batch management, issuance review, and closure processes] down by almost 50%."⁵

2. Enable Review by Exception

Traditional batch review requires examining every entry on every page, regardless of whether issues exist. Modern cell and gene therapy management solutions enable "review by exception," allowing quality teams to focus only on deviations from expected parameters.

This approach:

• Highlights only the entries that require attention.
• Eliminates line-by-line review of compliant entries.
• Provides real-time notification of potential issues.
• Reduces review cycles by focusing expert attention.

Organizations implementing review-by-exception capabilities typically reduce their GMP record review staff requirements by 30%-40% while accelerating reviews.

Ready to cut batch review time in half? Explore our Ultimate Guide to learn how digital solutions can transform your CGT manufacturing processes.

3. Automate Data Integrity Checks

Manual documentation reaches only 91% accuracy⁶—an unacceptable margin when patient lives hang in the balance. Modern cell therapy quality management software dramatically improves this through automated data integrity checks.

These systems:

• Validate data against predefined parameters in real-time.
• Prevent out-of-specification entries before they happen.
• Create audit trails of all data changes.
• Ensure consistent formatting of critical information.

The impact is measurable: organizations that implement automated data integrity checks experience 90% fewer data integrity errors and a 25% reduction in deviations.

4. Connect Quality and Manufacturing Systems

As previously mentioned, quality testing and batch release consume up to 70% of manufacturing lead time in CGT production. By connecting quality and manufacturing systems, organizations can build "Quality at the Source," embedding compliance into every production step.

Connected systems enable:

• Seamless launch of quality processes from production records.
• Real-time visibility of quality events affecting production.
• Immediate access to test results and quality data.
• Automated compliance checks throughout manufacturing.

This integration transforms quality from a post-production bottleneck into an in-line enabler of faster batch releases.

5. Deploy Cloud-Based Solutions for Multi-Site Scaling

As CGT organizations grow across multiple facilities, maintaining consistent processes becomes increasingly complex. Cloud-based cell and gene therapy software solutions create a digital backbone connecting your entire operation.

These platforms provide:

• Standardized processes across all manufacturing sites.
• Consistent review procedures everywhere.
• Real-time visibility into global operations.
• Secure chain of identity tracking across facilities.
• Efficient knowledge transfer between teams.

Don't let multi-site complexities slow your batch reviews. Download our Ultimate Guide to discover how cloud solutions standardize processes while accelerating reviews.

The Measurable Impact of Digital Transformation

Purpose-built digital systems designed specifically for cell and gene therapy manufacturing deliver transformative improvements to batch review cycles. MasterControl research has found that organizations implementing modern solutions experience:

• 75% faster batch reviews.
• 90% fewer data integrity errors.
• 25% reduction in deviations.
• 30%-40% fewer people dedicated to GMP record review.

These are much more than incremental improvements—they're transformational shifts that help organizations focus on what matters most: getting life-changing therapies to patients faster without compromising quality.

Preparing Your Digital Foundation for Growth

With over 2,800 companies actively developing CGT therapeutics worldwide, the industry shows no signs of slowing. Digital systems implemented early provide a scalable foundation that grows with your organization, from initial clinical trials through global commercial production.

Modern cell and gene therapy software solutions enable you to:

• Replace hundred-page batch records with streamlined digital workflows.
• Cut review time through exception-based processes.
• Break down data silos between systems.
• Scale seamlessly across multiple sites.
• Leverage AI for process optimization.
• Adapt quickly to regulatory changes.
• Make better decisions through unified data.

Ready to accelerate batch reviews by 75%? Download the Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing today and transform your operations for sustainable growth.

Conclusion

For CGT organizations navigating the path from research to commercial production, digital transformation is a proven path to efficiency. But it's also about possibility. By implementing these five digital strategies, you can dramatically reduce batch review times while scaling production to meet growing demand.

The future of cell and gene therapy manufacturing isn't just digital—it's connected, data-driven, and designed for rapid scaling. Organizations that embrace this reality today will lead tomorrow's breakthroughs, bringing hope to patients faster than ever before.

References:

1. "Dare to be Different: It's Time to Revamp Collaboration in Life Sciences Contract Manufacturing," Accenture Life Sciences.
2. "Cell and Gene Therapy market Size, Share and Trends 2025 to 2034," Precedence Research, July 14, 2025.
3. "Paying for Cures: Approved cell and gene therapy (CGT) products," Center for Biomedical System Design, Tufts Medical Center, accessed Sept. 16, 2025.
4. "2024 advanced therapy industry report", Deloitte.
5. MasterControl Case Study: Dendreon.
6. "Operations can launch the next blockbuster in pharma," Ulf Schrader, McKinsey & Company, Feb. 16, 2021.