Accelerating Biomanufacturing Facility Readiness: A Scalable Validation Model For Multiproduct Facilities

By Jevon Hsiao, Senior Director of Validation; Dongsun Park, Director of Validation Oversight; and Donghyuk Park, Associate Director of Validation Operations

Validating multiproduct biologics manufacturing facilities is not only a regulatory obligation but also a foundational component in safeguarding product quality and patient safety. As the biopharmaceutical landscape evolves—with increasing molecular diversity, emerging technologies, varying production scales, and heightened regulatory scrutiny—the process of validation has become significantly more intricate.

To navigate this complexity, a modern validation strategy must go beyond mere compliance. It must be both comprehensive and agile, ensuring that critical facility systems and manufacturing equipment are rigorously tested under conditions that closely mirror real-world operations. This enables organizations to mitigate risks early, streamline processes, and maintain consistent quality across diverse product pipelines.

Leveraging its deep expertise in large-scale biologics manufacturing, Samsung Biologics has pioneered an innovative and scalable validation framework. Developed through the successful commissioning of four major biologics plants, this methodology is engineered to accelerate facility readiness without compromising on regulatory compliance or product integrity.

This forward-thinking approach is now being implemented at Plant 5 on Samsung Biologics’ second Bio Campus — demonstrating its adaptability to new and expanding facilities. The framework provides a valuable model for contract development and manufacturing organizations (CDMOs) aiming to refine their validation protocols, reduce time to market, and uphold the highest standards of operational excellence.