5 Questions Every Cell Therapy Organization Should Ask Before Their Next FDA Audit
Preparing for an FDA audit in cell therapy isn’t just about documentation, it’s about readiness across people, processes, and technology. For patients whose treatment depends on precise, time-sensitive coordination, every operational detail matters. A single delay in scheduling, a missing timestamp, or an outdated SOP can extend a patient’s wait for a therapy they urgently need. In recent years, our team at Pragmatrix has observed one pattern across CMOs, CDMOs, and therapy developers: successful audits don’t happen in the audit room. They happen in the months leading up to it – inside workflows, touchpoints, and systems that either support teams …
Manual Processes in Cell Therapy: Small Delays, Real Consequences
In cell therapy, time is not an operational metric, it is a part of patient care. Every hour spent reconciling spreadsheets, coordinating by email, or verifying data manually is an hour a patient waits for treatment that could change their life. Across our work with cell therapy organizations, we’ve seen a recurring pattern: operational delays rarely begin with major breakdowns. They begin with small manual tasks – updating a batch record by hand, searching for a storage location, clarifying a label, confirming a shipment, checking whether all SOP steps were completed. Each task seems manageable in isolation. Together, they create …
Collaborative CGT Supply Chains: Improving Coordination, Compliance, and Visibility
The cell and gene therapy (CGT) industry is moving toward a future where coordination, not just capability, defines success. As therapies scale, organizations across the supply chain are discovering an essential truth: no single stakeholder can operate independently. Manufacturers, clinics, couriers, quality teams, and sponsors all contribute to a treatment journey that must be carefully aligned, compliant, and predictable. Yet despite the industry’s progress, collaboration remains one of the toughest challenges in CGT operations. Variations in scheduling, inconsistent documentation, and manual SOP execution often create administrative delays that limit therapy availability. When each stakeholder works in its own system, even …
Why Modular Software Architecture Is Becoming Essential for Cell Therapy Operations
The cell and gene therapy industry operates under a unique set of pressures. Every organization has distinct workflows, different regulatory requirements across regions, and specific operational processes that have been validated over years. Yet many software solutions on the market today force companies into a difficult choice: adopt a rigid, one-size-fits-all platform, or piece together multiple disconnected systems that create data silos and compliance gaps. Neither option serves the patient-centric mission that drives this industry forward. The Challenge: Complexity Without Flexibility GMP manufacturing environments are inherently complex. A CDMO managing multiple client programs needs different capabilities than a biotech running …
How Cellular Orchestration Platforms Handle the Diversity of Cell & Gene Therapies
The cell and gene therapy landscape in 2025 presents an unprecedented challenge: the pipeline contains over 4,000 candidates, half of them gene therapies – according to the American Society of Gene & Cell Therapy (ASGCT) and Citeline’s Q3 2024 report. Each therapy brings unique requirements for manufacturing, tracking, and delivery. From CAR-T cells requiring precise temperature control to allogeneic NK cells demanding different storage conditions, the diversity is staggering. Yet within this apparent chaos lies an opportunity for organizations that can master the complexity through intelligent software orchestration. The Scale of Diversity Challenges Modern Organizations Cell and gene therapies present …
