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Transferring an API manufacturing process to a contract manufacturing organization (CMO/CDMO) is one of the most critical steps in scaling a drug development program. Yet too often, tech transfers are treated like a simple handoff—when in reality, they require careful preparation, cross-functional collaboration, and technical rigor. A poorly executed tech […]

Drug development has never been more scientifically ambitious—or more operationally constrained. Sponsors today face heightened regulatory expectations, globalization of supply chains, accelerated clinical designs, and increasing pressure to ensure manufacturing robustness from the earliest stages. Chemistry, Manufacturing, and Controls (CMC), once viewed as a technical backend function, is now a […]