Lotte Biologics has announced the signing of its first official contract manufacturing agreement at its newly expanded antibody-drug conjugate (ADC) production facility in the United States. This milestone agreement, established with an Asia-based biopharmaceutical company, signifies the commencement of full-scale operations at Lotte Biologics’ ADC site within its Syracuse Bio Campus in New York.

While the identity of the partner company and specific details of the agreement remain confidential due to contractual obligations, the collaboration represents a pivotal step in Lotte Biologics’ strategy to establish itself as a global leader in ADC contract development and manufacturing organisation (CDMO) services.

The contract marks the company’s entry into the ADC manufacturing arena, following significant expansion of its Syracuse site, which has been underway since 2023. The facility, supported by an investment of approximately $100 million, is designed to meet current Good Manufacturing Practice (cGMP) standards and features a fully integrated, single-use system to ensure streamlined and flexible production of ADC therapies.

The state-of-the-art site boasts conjugation reactors with capacities of up to 1,000 litres, an in-house quality control (QC) laboratory, and advanced analytical capabilities. The facility enables a seamless process flow from antibody preprocessing to automated sterile filling of drug substances, positioning Lotte Biologics to support its clients across the full ADC lifecycle—from clinical development through to commercial manufacturing.

James Park, Chief Executive Officer of Lotte Biologics, commented:
“With this agreement, we are laying the foundation to reliably supply high-quality ADC medicines to the global market. This achievement underscores our commitment to becoming a trusted CDMO partner not only for antibodies but also for ADCs. We remain focused on building strategic partnerships that will further enhance our competitiveness and presence in the ADC modality sector.”

The ribbon-cutting ceremony at the Syracuse plant, marking the opening of the new ADC facility, was attended by key executives including James Park, and Shin Yu-yeol, Head of the Global Strategy Division at Lotte Biologics and the eldest son of Lotte Group Chairman Shin Dong-bin, along with other employees and guests.

Lotte Biologics plans to leverage this agreement to expand its global client base and foster new collaborations in the ADC space, reinforcing its role as a global CDMO player and contributing to the advancement of innovative biopharmaceutical therapies worldwide.