Samsung Biologics Cuts Seed Culture Time in Half

Samsung Biologics has introduced the next-generation continuous processing technology known as N-1 perfusion culture, shortening the seed culture period, a key step in biopharmaceutical production, from 28 days to as few as 12 days. The reduction of approximately 50%, or 16 days, is drawing attention in the global contract development and manufacturing organization (CDMO) market, where lower production costs and shorter delivery times determine competitiveness in winning contracts.

N-1 perfusion culture uses an alternating tangential flow (ATF) device to filter waste during the culture process while continuously supplying fresh media. This enables the company to maintain cell viability above 98% and increase cell density by up to 10-fold.

When the high-density cultured cells are transferred to a 15,000 L commercial production bioreactor, the total production time can be reduced by up to an additional 30%. Innovation in the seed culture stage translates into efficiency across subsequent commercial production.

■ Combined with automated quality control

Samsung Biologics has gone beyond shortening the process by introducing the Growth Direct platform from U.S. life sciences technology company Rapid Micro Biosystems to fully automate microbial quality control.

Converting predominantly manual microbial testing to an automated system reduces human error and improves data integrity. The company has achieved both compliance with the stringent standards of global regulatory agencies, including the U.S. FDA, and shorter processing times.

Robert Spignesi, CEO of Rapid Micro Biosystems, said, "The expansion of our partnership with Samsung Biologics demonstrates the importance of automated quality control solutions in large-scale biopharmaceutical manufacturing." He added, "The platform delivers faster results and improved data integrity to production sites, maximizing global regulatory compliance and operational efficiency."

■ Synergy with the world's largest production capacity

Process innovation takes on greater significance when combined with Samsung Biologics' dominant production scale. Including Plant 5, which recently began operations, Samsung Biologics currently has production capacity of approximately 784,000 to 845,000 L, placing it among the world's largest.

Upon completion of the second Bio Campus in 2032, total capacity is expected to expand to 1,324,000 L. Production capacity is already at the highest level, but improving process efficiency will enable the company to handle more batches with the same facilities.

As global pharmaceutical companies increase their outsourcing of complex antibody drugs, shorter production times serve as a key competitive advantage in ensuring the timely market launch of new drugs. Industry experts believe that combining N-1 perfusion culture with automated quality control is highly likely to become a new industry standard in the global CDMO sector.

Samsung Biologics' manufacturing science and technology (MSAT) expert group said, "The global biopharmaceutical industry is facing pressure to reduce drug prices and market uncertainty." The group added, "Hybrid continuous manufacturing technologies such as N-1 perfusion culture are the most powerful alternative for overcoming the limitations of conventional batch processes, lowering production costs and rapidly supplying high-quality medicines."

This process innovation also provides a foundation for expanding the business beyond a portfolio centered on monoclonal antibodies into next-generation biopharmaceuticals, including antibody-drug conjugates (ADCs), peptides for GLP-1 obesity treatments and mRNA. The production efficiency and available capacity secured through the innovation are practical prerequisites for attracting contracts for new modalities.