Why Cell Therapy Visibility Must Start at Patient Enrollment – Not Manufacturing
In many cell therapy programs, visibility is often viewed as a manufacturing responsibility. Where is the batch? Which step is currently active? Has quality review been completed? These are valid and necessary questions. Manufacturing visibility remains a foundational requirement for maintaining FDA compliance, supporting GMP environments, and aligning with validated Standard Operating Procedures (SOPs). But over time, many organizations have begun to notice something important: Manufacturing visibility alone does not provide the full picture. Cell therapy is fundamentally different from traditional pharmaceutical manufacturing. It is not batch-first manufacturing. It is patient-first manufacturing. And the patient journey begins long before the …


