LOTTE Biologics is focusing on expanding its quality standards across its global operations in 2026. The company aims to strengthen its organizational quality culture and prepare for the launch of its new Bio Campus in Songdo, South Korea.
Emily Yourd, associate director of Quality Assurance Compliance at LOTTE Biologics, told BioSpace, “We’re really excited about the future of LOTTE Biologics and 2026 is shaping up to be very exciting year.” She explained that continuous improvement efforts are being coordinated between the Syracuse Bio Campus and colleagues in Korea as they ready the Songdo facility for operations.
Yourd described a proactive contamination control strategy at LOTTE Biologics. The company centralizes its principles through a comprehensive document guiding facility and equipment design. It uses closed and functionally closed systems when possible, with validated cleaning procedures to prevent exposure or contamination. Single-use technology will also be implemented at the new ADC facility.
Operational controls include robust cleaning routines, product changeover procedures, gowning protocols, and material flow processes. These measures are supported by personnel training programs. According to Yourd, “Through all these various factors, we ensure that our risks are identified, properly mitigated, where possible, and controlled. The goal is to control these risks before they can actually have any impact on our product quality or patient safety.”
The company maintains readiness for regulatory inspections at all times. “Our personnel take a lot of pride in the sites, and that leads to a sense of ownership at every level,” Yourd said. “This leads to an environment where all team members across the site are empowered to identify and escalate any potential concerns before they turn into problems.”
Internal self-inspection includes management walk-throughs and audits by cross-functional teams for diverse perspectives and prevention of complacency.
To support global compliance efforts, LOTTE Biologics tracks regulatory trends through a dedicated group monitoring updates from authorities worldwide regarding guidance revisions or compendial changes related to material testing. “This process lets us be proactive in assessing any impact that these changes may have to our systems and allows us to make any adjustments in a timely fashion,” Yourd said.
LOTTE Biologics distributes products in over 60 countries. Clients are encouraged to visit facilities and participate in regular meetings for status updates and timely decision-making. As Yourd noted: “We have regularly scheduled meetings with our clients to ensure that they’re kept up to speed on the status, and so that we can make any timely decisions that are needed.”
This article was written in partnership with LOTTE Biologics.
