South Korea, US to build advanced biopharmaceutical measurement standards platform

South Korea and the United States' leading metrology institutions are joining forces to build a cooperative framework through information exchange and networking on advanced biopharmaceutical measurement standards, with the aim of accelerating research and development and disseminating results.

The Korea Research Institute of Standards and Science (KRISS) said Tuesday it held the 3rd Advanced Biopharmaceutical Measurement Standards Symposium and announced plans to work with the US National Institute of Standards and Technology (NIST) to build an advanced biopharmaceutical quality control platform.

The global advanced biopharmaceutical industry is growing rapidly, offering new treatment paradigms in modern medicine. For domestically developed therapeutics to reach global markets, ensuring quality and safety is essential — making the development of internationally recognized measurement standards and close collaboration among industry, academia, research institutes, government and hospitals increasingly critical.

The event also featured the launch of the Strategic Research Project to Build an Advanced Biopharmaceutical Quality Control Platform, which got fully underway this year. The project will receive a total of 39.7 billion won ($25.9 million) through 2030. KRISS plans to use it to accelerate the establishment of quality control standards for advanced biopharmaceuticals and the development and dissemination of new measurement technologies.

KRISS is currently working closely with NIST through the Korea-US Strategic Technology Pre-standardization Joint Research Project to build measurement standards for advanced biopharmaceuticals and precision medicine biomaterials. The two institutions are using that foundation to strengthen the Korea-US science and technology alliance and standards cooperation in the biotech sector.

In the United States, a consortium linking NIST, the Food and Drug Administration and industry is actively conducting research. KRISS plans to model a similar structure domestically — forming a measurement standards-based consortium centered on KRISS that connects the Ministry of Food and Drug Safety and industry. The goal is to establish a domestic cooperation framework spanning quality control standards development, regulatory response and industrial application.

"KRISS will not only deepen its research collaboration with NIST, but also benchmark the NIST-FDA-industry cooperation model in the United States to build a quality control partnership framework among measurement standards institutions, regulatory bodies and industry suited to domestic conditions," KRISS President Lee Ho-seong said. "Through this, we will actively support Korea's biotech industry in securing the quality competitiveness needed to earn trust in global markets."