Utilizing Small-Scale Downstream Studies Across Biologics Manufacturing

By Donggu Oh and Taekeun Kim, Samsung Biologics

As biologic therapies become more complex and regulatory demands intensify, biopharmaceutical manufacturers must deliver high-quality, safe, and effective products with increasing efficiency. Central to achieving this is a robust tech transfer process, which ensures that product and process knowledge are effectively shared between development and manufacturing units or between manufacturing sites. Small-scale downstream studies, often underestimated, are pivotal to this process, as they provide a cost-effective, flexible way to investigate process behavior, optimize operations, and uncover potential risks well before full-scale production begins.

These studies support tech transfer by generating predictive data, confirming process robustness, and de-risking scale-up activities. Key small-scale studies include verification runs, filter sizing tests, and investigational studies. Verification runs, in particular, serve as a critical bridge between development and commercial manufacturing, helping to confirm that transferred processes perform consistently and meet quality expectations at the receiving site.

When integrated into a structured, collaborative tech transfer workflow, small-scale downstream studies help ensure facility fit, strengthen communication between stakeholders, and reduce the risk of delays or failures during scale-up. This approach accelerates time to market while enhancing regulatory readiness and operational reliability, making it an essential strategy for successful biologic manufacturing in today’s competitive and highly regulated environment.