Sartorius
Korea Biotech LLC
Sponsor Interview (2026)
Q. Which product, technology, or solution would you most like visitors to pay attention to at BIX 2026? What differentiates your solution from others in the market?
A. At BIX 2026, we would like to highlight not a specific Sartorius product, but the regulatory-validated raw material and quality control services provided by the Sartorius Korea Corporate Research Institute.
Two of the biggest risks in biopharmaceutical development are unstable raw material supply and delays in regulatory approval. In March 2025, our institute became the first in Korea to obtain GMP certification from the Ministry of Food and Drug Safety (MFDS) for a biopharmaceutical raw material manufacturing facility, officially validating the reliability of its cell bank manufacturing and cell line characterization testing capabilities.
In May 2026, the institute also achieved EU GMP compliance for quality control testing of Unprocessed Bulk Harvest (UBH) and was officially registered in EudraGMDP, the European regulatory database.
Based on these capabilities, Sartorius Korea supports not only CRO services, but also cell banking CMO services covering both manufacturing and testing, with plans to expand into microbial and viral banking services.
Once connected with the Songdo manufacturing facility scheduled for completion in early 2027, this will establish an integrated structure spanning research and validation through to commercial manufacturing.
Our key differentiator is that these services are provided locally in Korea, helping customers reduce both supply chain risks and regulatory delays.
Q. The use of digital technologies such as AI, data analytics, and digital twins is rapidly expanding in biopharmaceutical manufacturing. What technology trends is Sartorius paying the closest attention to, and what new value can these innovations bring to customers?
A. One of the key technology trends Sartorius is currently focusing on is Physical AI-based closed-loop control, which enables autonomous control of actual bioprocessing hardware, supported by hybrid digital twins.
Biopharmaceutical manufacturing involves living cells, which can respond to even subtle environmental changes with complex, nonlinear variations. To address this, Sartorius is developing a Physical AI architecture that integrates BioPAT® sensors—including Raman spectroscopy platforms and capacitance-based biomass monitoring—with the Biobrain® platform, which manages and controls the bioreactor environment. This integrated approach enables processes to maintain optimal conditions with minimal human intervention.
To ensure reliable Physical AI control, Sartorius also applies hybrid modeling, combining mechanistic models based on cell growth dynamics with data-driven machine learning. Since bioprocess data is costly to generate and often limited in volume, this approach can achieve highly accurate growth-curve predictions even with relatively small datasets.
Ultimately, these technologies can help reduce batch failure rates, shorten process development timelines and time-to-market, and mitigate risks associated with scale-up and technology transfer.
