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Strategic Foundation: Why Commercial Ready Manufacturing Should Be Considered from Day One
Автор: Phacilitate TV
Загружено: 2026-02-10
Просмотров: 19
Описание: 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.
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