Seamless Technology Transfer: Accelerating Biologics From Drug Substance To Drug Product

By Sangkyu Hwang, Senior Director of MSAT Technical Excellence; and Brian Heo, Director of Project Management

As biologics pipelines continue to evolve, technology transfer (tech transfer) has become increasingly complex, requiring strategies that can adapt to more sophisticated molecules, evolving manufacturing platforms, and heightened regulatory scrutiny. The growing adoption of process intensification, digital manufacturing technologies, and standardized single-use and stainless-steel production systems has further elevated the need for efficient, well-executed transfers that preserve process knowledge, maintain product quality, and support development timelines.

To meet these demands, Samsung Biologics has developed a Manufacturing Science and Technology (MSAT)-led tech transfer framework designed to drive consistency, reduce risk, and enable successful scale-up from clinical to commercial manufacturing. By combining structured risk assessments, standardized workflows, robust knowledge management, and expertise across multiple scales of development and production, the framework helps ensure seamless execution and reproducible outcomes throughout the transfer process.

This integrated approach enables reliable, right-first-time technology transfers, minimizing delays, reducing operational complexity, and supporting faster progression to market while maintaining the quality, compliance, and process robustness required for long-term commercial success.