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 A single delay in scheduling, a missing timestamp, or an outdated SOP can extend a patient’s wait for a therapy they urgently need.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 …
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 …
