Strategic Foundation: Why Commercial Ready Manufacturing Should Be Considered from Day One

Cell therapy manufacturing is defined by biological variability, sensitive unit operations, evolving analytical methods, and fragile supply chains-factors that collectively introduce profound risk into programs. Regulators have taken notice and continue to enhance guidance that early-phase programs must demonstrate meaningful process understanding even before human trials begin. These expectations reflect a broader shift across the industry: manufacturability is no longer something to address “when the time comes”-it must be built into the therapy from day one.