With inspections always on the table, LOTTE Biologics is pushing a proactive, quality first culture across its dual hubs in Syracuse and Songdo, backing its new single‑use ADC facility with rigorous training, self‑audits and real‑time regulatory surveillance.
LOTTE Biologics has big plans for 2026. Top priorities include expanding its strong quality culture across the organization to ensure a harmonized, global system, and nurturing the build-out of its new Bio Campus in Songdo, South Korea.
“We’re really excited about the future of LOTTE Biologics and 2026 is shaping up to be very exciting year,” said Emily Yourd, LOTTE Biologics’ associate director, Quality Assurance Compliance, in an interview with BioSpace.
The continuous improvement in its quality culture slated for this year ties into the Syracuse Bio Campus, and working closely with Korean colleagues to prepare the Songdo, South Korea Bio Campus for operations, she added.
In terms of its quality philosophy, LOTTE Biologics has laid out a proactive and systematic approach in its contamination control strategy, Yourd explained. This is a comprehensive document that centralizes its principles in terms of facility and equipment design. For example, LOTTE Biologics uses closed and functionally closed systems wherever possible, and there are validated cleaning procedures associated with these systems to prevent any exposure or potential ingress. In the new ADC facility, leverage single-use technology is employed as well.
In addition to the engineering controls to prevent contamination, LOTTE Biologics employs a combination of operational controls and monitoring. This involves robust cleaning and product changeover procedures, as well as gowning and material flow protocols, Yourd said. This is all supported with a strong personnel training program.
“Through all these various factors, we ensure that our risks are identified, properly mitigated, where possible, and controlled,” Yourd said. “The goal is to control these risks before they can actually have any impact on our product quality or patient safety.”
Inspection Ready At All Times
The result is that LOTTE Biologics is ready for inspections, either planned or unplanned, by regulatory authorities at any time, Yourd said. “Our personnel take a lot of pride in the sites, and that leads to a sense of ownership at every level,” she explained. “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.”
As part of this robust, internal self-inspection auditing process, LOTTE Biologics has management conducting floor doing walk-throughs, actively looking to make sure that the area is in a controlled state, Yourd added. The internal auditing also includes cross-functional team members, to allow fresh perspectives to ensure there is no complacency.
In addition to strong quality processes to support consistent global compliance, LOTTE Biologics has robust regulatory and compendium surveillance, Yourd said. This is a group of scientists, quality assurance employees, and other departments that track global regulatory trends and upcoming revisions to regulatory guidances, as well as compendial updates for aspects like material testing, she added.
“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,” she said. LOTTE Biologics’ products are distributed across more than 60 countries.
Clients are also welcome to have plant visits. “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,” Yourd said.
This article was written in partnership with LOTTE Biologics.
