5 Signs Your Lab Has Outgrown Spreadsheet-Based Sample Tracking (and What to Do Next)
Spreadsheets have supported life sciences teams for decades. They’re familiar, flexible, and quick to set up. But as labs scale, especially in regulated environments like cell therapy, biobanking, and advanced biologics – what once worked can quietly become a source of risk. Over the years, our team at Pragmatrix has had the opportunity to work alongside CDMOs, CMOs, and biotech organizations navigating this exact transition. A consistent pattern emerges: spreadsheets don’t usually “fail” overnight. They simply stop keeping pace with operational and regulatory realities. Here are five signs your lab may have outgrown spreadsheet-based sample tracking and key considerations for …
Scaling CAR-T Operations: The 7 Handoffs That Require End-to-End Traceability
Personalized cell therapies don’t fail at a single point. They strain at the transitions. Across the CAR-T journey, patient material moves through multiple teams, locations, and systems – each governed by strict FDA regulations, GMP requirements, and SOPs. What has been observed over years of supporting cell therapy organizations is that handoffs, not core science, are where complexity quietly accumulates. Each transition introduces a moment where visibility can narrow, documentation can fragment, and coordination becomes harder than expected. Understanding these handoffs and what they require to remain compliant is increasingly important for CMOs, CDMOs, and biobanks scaling advanced therapy programs. …
Apheresis Scheduling in Cell Therapy: How It Works and Where Alignment Breaks Down
Apheresis scheduling is one of the most time-sensitive steps in the cell and gene therapy (CGT) lifecycle. On paper, the process appears linear: schedule the patient, collect cells, move to manufacturing. In real-world GMP environments, apheresis scheduling is rarely that simple. It sits at the intersection of patient readiness, collection site capacity, manufacturing availability, and regulated logistics. When these elements are not aligned, small scheduling changes can cascade across the supply chain – often without immediate visibility. Across CMOs, CDMOs, and therapy developers, a consistent pattern emerges: scheduling itself is not the problem – disconnected processes are. This article explains …
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 …
Supply Chain Integration with PragLife: Orchestrating Seamless Connectivity Across the Cell & Gene Therapy Ecosystem
In cell and gene therapy manufacturing, the difference between a life-saving treatment reaching a patient on time and a critical delay often comes down to one factor: supply chain integration. The complexity is staggering. A single CAR-T therapy journey involves coordinating patient enrollment, apheresis scheduling, cryopreservation, transportation across multiple time zones, GMP manufacturing, quality control, final product delivery, and patient infusion, all while maintaining perfect Chain of Identity (COI) and Chain of Custody (COC) at every touchpoint. Manual coordination across these stakeholders is not just inefficient. It’s a patient safety risk. The Integration Imperative in Personalized Therapies Cell and gene …
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 …
