[Interview] Hugel executive: 'Goal is global No. 1 toxin with cutting-edge automation to speed territorial expansion'

Seol Hee-soo (49), executive managing director of Hugel's Production and Quality Business Division, expressed this strong ambition while explaining the company's vision for the global market. Seol, who has worked at major domestic biotech companies including Green Cross and Kolon Life Science, is a field expert who currently oversees all processes at Hugel from botulinum toxin bulk manufacturing to finished product shipment, including production, facility operation and quality control.

Meeting with Seol at the Chuncheon Geodu factory on Thursday, he presented specific details about the advanced achievements of Building B, which began full commercial production in April 2025, and the global territorial expansion strategy being pursued based on this foundation.

Seol said the recently launched Geodu factory Building B is a key outpost in the global supply chain. "As demand for Hugel toxin continues to increase in the global market, we began commercial production at Geodu factory Building B," he said. "We currently have secured annual production capacity of up to 13 million vials based on freeze-dried products, establishing a mass production system that is about 2.3 times larger than our past production scale."

The cutting-edge automation line introduced in Building B is achieving innovative results in process efficiency beyond simple volume expansion. "Building B has actively introduced the latest automation equipment and has about 1.6 times the production capacity compared to the existing Building A," Seol said. "Based on this automation system, we are continuing process improvements and expect to dramatically reduce finished product production time by about 40 percent compared to existing methods."

However, he made clear that mechanical automation does not automatically guarantee global quality standards (GMP). His philosophy is that to satisfy strict cGMP (US current Good Manufacturing Practice), clear standard operating procedures must be established and a system that verifies the "people" who perform them must be perfectly supported. "We are focusing most on balancing maximizing the benefits of automation systems that minimize human intervention to prevent contamination while rigorously verifying both the system and operating personnel," Seol added.

Based on this thorough quality control system, Hugel is accelerating its entry into global major markets. Building B at Geodu factory completed domestic manufacturing approval last year and is currently going through licensing change procedures sequentially in major overseas countries.

"In April this year, we submitted a PAS (Prior Approval Supplement) to the US FDA for adding Building B as a manufacturing facility," Seol said. "Starting with this, from next year we will pursue sequential licensing changes targeting major countries worldwide to fully expand our global supply system."

The unique technical strength of Hugel's botulinum toxin that he highlights is its "narrow diffusion" characteristic. Because the range of drug spread around the treatment area is narrow, precise and predictable treatment effects can be expected at target sites. "The uniform quality and safety accumulated through more than 15 years of use in actual clinical settings is the secret to gaining the trust of global doctors," Seol said.

Hugel's Production and Quality Business Division is also preparing additional process evolution to maximize production efficiency in the future. Around the end of this year, it plans to apply to the Ministry of Food and Drug Safety for permission to change to a "reduced pressure drying" process that can dramatically reduce process time by improving the existing freeze-drying method. Validation (quality verification) work for this is currently underway. The company also plans to steadily obtain domestic and overseas approvals for the new bulk drug substance facility being built within Building B after thorough quality verification.

Seol suggested a medium- to long-term facility investment roadmap for leaping to become a global No. 1 company. "At this point, we have sufficient capacity to stably respond to global demand," he said, "but given that the global toxin market continues to grow and Hugel is also continuing steep growth, additional factory expansion is a matter of timing."

"We will comprehensively review future global demand trends and market changes to determine the optimal expansion timing from a medium- to long-term perspective," he said, expressing his determination to complete a global No. 1 production base that flawlessly supports the world market.