Innovative Solutions For Bioprocessing Challenges: How MSAT Drives Efficient Tech Transfer

By Youngsun Kim, Byungsun Lee, Busol Park, Jihyeon Oh, and Lalit Saxena, MSAT, Samsung Biologics

Complex biomanufacturing processes and a shifting regulatory landscape necessitate effective tech transfer for timely delivery of life-saving treatments. Contract development and manufacturing organizations (CDMOs) with robust Manufacturing Science and Technology (MSAT) expertise play a central role, harnessing flexibility, late-stage process optimization, and continued process verification (CPV) to meet the needs of the modern healthcare landscape.

Samsung Biologics has optimized its tech transfer workflow, integrating more automated, digitalized workflows to its processes to achieve seamless tech transfer and scale up for its customers. These efforts also encompass standardization and simplification efforts for small-scale verification and satellite run operation in the tech transfer process, with ongoing efforts aimed at improving efficiency and reducing transfer timelines. By focusing on establishing process control strategies (PCS) and authoring master batch records (MBR), Samsung Biologics’ MSAT aims to seamlessly scale up or down customer processes across various sizes of its manufacturing facilities from the initial request for proposal (RFP) stage. This proactive approach aligns with Samsung Biologics’ overarching goal of supporting manufacturing activities by understanding client processes and ensuring the best facility fit during tech transfer.