Build a Scalable Digital Foundation for CGT Manufacturing
Scale CGT Manufacturing With Digital Confidence
Cell and gene therapy manufacturing is transforming medicine, but outdated paper-based processes are holding back your potential to scale. Unlike traditional pharmaceuticals, CGT manufacturing demands precision handling of batch-of-one workflows, variable patient materials, and stringent chain-of-identity requirements—all within narrow time windows where delays can cost patients their eligibility for life-saving treatment.
Digital transformation isn't optional anymore; it's essential. This industry brief reveals how leading CGT manufacturers are building scalable digital foundations that control complexity, accelerate batch release, and protect what matters most: getting therapies to patients on time. Discover the practical roadmap from basic digitisation to enterprise-wide integration that's purpose-built for advanced therapies manufacturing.
- Discover the progressive path from basic digital documentation to fully integrated manufacturing ecosystems that grow with your organisation.
- Learn how digital solutions address the unique challenges of CGT manufacturing, from chain-of-custody tracking to rapid batch release.
- Understand the digital prerequisites for patient-proximate production that can dramatically reduce vein-to-vein time.
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Why Digitisation Matters for CGT Manufacturers
In CGT manufacturing, minutes matter. Paper-based reviews consume days, manual data entry introduces costly errors, and siloed systems obscure critical real-time visibility across production. These aren't minor inefficiencies—they're systemic weaknesses that compound under the inherent variability of advanced therapies. When you attempt to scale or decentralise without digital standardisation, sites drift in procedures, training diverges, and process controls weaken. The result? A cascade of quality risks impacting the one stakeholder who cannot afford delays: your patient. Digital traceability and efficient batch release aren't operational conveniences—they're patient-preserving necessities.
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Ready to Scale With Confidence?
Download the brief to discover your roadmap for CGT manufacturing excellence.
Get the Industry BriefYour CGT Manufacturing Questions Answered
What integration benefits does the brief highlight for scaling CGT operations?
The brief details how QMS-EBR-LIMS connectivity reduces manual reconciliation, accelerates batch release, decreases deviations, improves tech transfer, and strengthens cross-functional collaboration.
What digital maturity progression does the brief outline for CGT manufacturers?
The brief details a three-stage journey: establishing the basics, strengthening and connecting systems, and achieving enterprise-wide integration and orchestration as organizations scale.
Does the brief explain how to start building a digital foundation with limited resources?
Yes, it outlines foundational tools for early-phase developers with small teams and budgets, focusing on digital document management, electronic logbooks, and deviation tracking.
Does the brief address decentralised manufacturing challenges for CGT producers?
Yes, it explains how distributed, patient-proximate manufacturing requires harmonised digital processes, consistent data capture, and real-time visibility across all manufacturing locations.
MasterControl: Built for Advanced Therapies Manufacturing
MasterControl Manufacturing Excellence (Mx) connects operators, equipment, and quality processes through intelligent workflows with built-in guardrails. Move beyond basic digitisation to achieve the integrated digital foundation that CGT manufacturing demands: embedding quality directly into execution rather than treating it as a separate afterthought.
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Quality Integration
Embed quality controls directly into manufacturing workflows, preventing deviations through in-line verification steps and real-time exception flagging for immediate intervention.
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Intelligent Workflows
Enforce training requirements at the moment of execution and automatically link equipment qualification status to batch eligibility for seamless compliance.
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Review Efficiency
Leverage electronic batch records and review-by-exception capabilities to accelerate time-sensitive release decisions while maintaining complete traceability and data integrity.
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Scalable Platform
Achieve faster, safer batch releases through cloud-based integration that completely removes paper from operations, reducing waste while getting therapies to patients on time.
