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 A single delay in scheduling, a missing timestamp, or an outdated SOP can extend a patient’s wait for a therapy they urgently need.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 …
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 …
Cell and Gene Therapy Trends for 2026: Navigating the Evolution of Advanced Therapeutics
By the end of 2026, the way we manufacture cell and gene therapies will look fundamentally different than it does today. Not because of scientific breakthroughs alone, but because operational realities are forcing a transformation that’s long overdue. The cell and gene therapy (CGT) landscape stands at a pivotal moment. With over 3,700 therapies in clinical and preclinical development and 76 products already launched globally, 2026 promises to be a defining year where innovation meets operational reality. For patient-centric organizations, CMOs, and CDMOs, understanding these emerging trends is not just about staying current, it’s about positioning your operations for sustainable …
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 …
Why Cell Therapy Supply Chains Need Cellular Orchestration Platforms
The cell and gene therapy (CGT) landscape has evolved dramatically over the past decade. With over 3,000 clinical trials worldwide and commercial therapies reaching patients at unprecedented speed, the industry faces a critical challenge orchestrating increasingly complex supply chains that span continents and involve multiple stakeholders. Unlike traditional pharmaceuticals manufactured in standardized batches, cell therapies follow a personalized model where each treatment is unique to one patient. This fundamental difference creates cellular orchestration challenges that traditional supply chain management approaches simply cannot address. The Complexity Challenge in Cell Therapy Supply Chains Cell therapy supply chains operate fundamentally differently from conventional …
