Workflow Orchestration: Why Executing Steps in the Right Sequence Matters for GMP Compliance
In cell therapy manufacturing, progress isn’t just about moving faster. It’s about …
How MES Helps Ensure GMP Compliance in Manufacturing
In regulated manufacturing, compliance is often treated as a checklist. A set of SOPs to follow. A …
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 …
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. …
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) …
Autologous vs. Allogeneic Cell Therapies: Supply Chain Differences That Impact Scale and Compliance
Autologous and allogeneic cell therapies are often compared from a scientific or clinical …
How to Digitize Your SOPs Without Disrupting FDA-Validated Processes
In the fast-evolving world of cell and gene therapy, operational efficiency is more than a business …
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 …
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 …
