How Modular Software Enables 4-6 Month Implementation in Cell & Gene Therapy
In cell and gene therapy (CGT), speed matters. Not just for operational efficiency. But for patients waiting at the end of the supply chain. Yet many organizations still face 12–24 month software implementations before they see meaningful value. In an industry governed by FDA regulations, GMP requirements, validated SOPs, and 21 CFR Part 11 compliance, digital transformation often feels slow, expensive, and risky. The question isn’t whether digital systems are necessary. It’s how they’re implemented. The Problem: “All-or-Nothing” Systems Traditional CGT software platforms typically require organizations to deploy everything at once: For CMOs, CDMOs, and biotech manufacturers operating in regulated …
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 …
