Lotte Biologics, the contract drug-manufacturing arm of South Korea’s Lotte Group, is sharpening its focus on antibody-drug conjugates, or ADCs, as it seeks to carve out a stronger position in the crowded global market for biologics manufacturing.
The company is accelerating what it calls a “global quality integration” strategy, linking its manufacturing operations in the United States and South Korea under a single quality framework. Executives say the effort reflects a view that in advanced biologics, operational scale alone is no longer enough to compete.
Lotte Biologics said Jan. 23 that it is building a unified global quality system spanning its biomanufacturing campus in Syracuse, N.Y., and its facility in Songdo, South Korea. The initiative is anchored by a single-use ADC manufacturing plant in Syracuse that is scheduled to begin full-scale operations later this year.
ADCs, which combine monoclonal antibodies with potent cytotoxic drugs, are among the most technically demanding biologic therapies to produce. Product quality can be affected by even minor contamination or process deviations, making quality control and regulatory readiness decisive factors in CDMO contract awards, industry executives say.
To address those risks, Lotte Biologics has made preemptive contamination control central to its quality strategy. Closed and functionally closed systems were incorporated from the facility and equipment design stage, while extensive cleaning validation protocols have been paired with single-use technologies to limit external exposure and reduce cross-contamination risk.
Operational discipline has been tightened across sites. The company has standardized cleaning and product changeover procedures, introduced strict gowning and material-flow controls, and installed real-time environmental monitoring systems. Training programs emphasize prevention over remediation, aiming to identify and mitigate risks before quality deviations emerge.
The quality framework is closely aligned with the company’s regulatory compliance approach. Rather than preparing only for scheduled audits, Lotte Biologics operates on a constant inspection-readiness model. Senior management participates directly in on-site inspections, and cross-functional internal audits are used to reinforce oversight and accountability.
A dedicated regulatory team continuously tracks changes in international guidelines and pharmacopeias, assessing their impact on internal quality systems and incorporating updates proactively. With products supplied to more than 60 countries, the company says adherence to global standards—rather than country-specific benchmarks—is essential to its business model.
Industry specialists say the emphasis on quality-system maturity could help differentiate Lotte Biologics in the ADC CDMO market, where expanding capacity alone has become a less reliable competitive advantage. In this segment, a demonstrable track record in quality management and regulatory compliance often carries significant weight in customer decisions.
“Our goal is to identify potential risks early and control or mitigate them as much as possible,” said Emily Yourd, associate director of quality-assurance compliance at Lotte Biologics. “We are building systems that manage risk before it can affect product quality or patient safety.”
Lotte Biologics plans to position Syracuse as its North American hub for ADC manufacturing, while Songdo will serve as a core biomanufacturing base in Asia. By integrating the two sites under a single global quality standard, the company aims to move beyond basic production services and establish itself as a high-value CDMO partner in advanced biologics.
