LOTTE BIOLOGICS announced on April 24 that it has signed its first manufacturing agreement for a clinical-stage antibody-drug conjugate (ADC) candidate with an undisclosed Asia-based biotech company, marking the official launch of its ADC contract development and manufacturing organization (CDMO) business.
The agreement represents the first client contract for LOTTE's dedicated ADC manufacturing facility at the Syracuse Bio Campus in New York, which has been under expansion since 2023 following the company's acquisition of the former Bristol-Myers Squibb site in May 2022.
Strategic Expansion into ADC Manufacturing
The newly operational ADC facility, built with an investment of approximately $100 million, is designed to provide end-to-end services for ADC development and manufacturing. The cGMP-compliant site features an integrated production and purification line, including a conjugation reactor with a capacity of up to 1,000 liters.
"The ADC market is rapidly growing. In response, we have officially launched our dedicated ADC facility and one-stop service," a LOTTE spokesperson stated. The facility is equipped with a single-use system supporting the entire process from antibody preprocessing to automated aseptic filling of drug substances, enabling flexible responses to diverse client requirements.
James Park, CEO of LOTTE BIOLOGICS, emphasized the strategic importance of this development: "With this contract as a starting point, we will ensure a stable supply of high-quality ADC therapeutics and solidify our position in the global market, not only as an antibody manufacturer but also as a CDMO specializing in ADCs."
Comprehensive Service Capabilities
The Syracuse facility offers comprehensive capabilities including in-house quality control testing and advanced characterization services. This expansion complements LOTTE BIOLOGICS' existing biologics manufacturing capacity of 40,000L through eight 5,000L stainless steel bioreactors at the same campus.
The strategic location in New York provides significant advantages for serving the North American market. "The US accounts for a significant portion of global ADC clinical trials. Local production in Syracuse enables rapid supply, logistical efficiency, and strong regulatory compliance for North American biotechs and pharma companies," according to a company spokesperson.
The integration of antibody production capabilities with dedicated ADC lines enhances LOTTE's ability to provide seamless end-to-end services, a key differentiator in the competitive CDMO landscape.
Global Expansion Plans
While specific details regarding the contract duration, financial terms, and manufacturing schedule remain confidential, LOTTE BIOLOGICS has indicated plans to pursue additional client acquisition opportunities and expand partnerships to offer comprehensive one-stop services for ADC development and manufacturing.
This ADC facility launch is part of LOTTE BIOLOGICS' broader global expansion strategy. The company is currently constructing three advanced bio plants in Songdo, South Korea, with a combined manufacturing capacity exceeding 360,000L. The first plant is expected to be operational by 2027.
Each of the Songdo facilities will feature eight 15,000L stainless steel bioreactors for large-scale commercial production, along with multiple 2,000L single-use bioreactors to meet clinical production needs.
ADC Market Significance
Antibody-drug conjugates represent one of the fastest-growing segments in the biopharmaceutical industry, combining the targeting precision of monoclonal antibodies with the potent cell-killing capabilities of cytotoxic payloads. This modality has gained significant traction in oncology and other therapeutic areas.
By establishing dedicated ADC manufacturing capabilities, LOTTE BIOLOGICS is positioning itself to capitalize on the increasing demand for specialized production of these complex therapeutics. The company's integrated approach allows it to leverage synergies between its extensive experience in regulatory inspections, state-of-the-art equipment, and existing monoclonal antibody expertise.
The Syracuse Bio Campus, which has received approval from over 62 regulatory agencies worldwide, provides LOTTE BIOLOGICS with a strong foundation for its ambitious expansion into the ADC space as it works to become a global leader in integrated support for ADC development, clinical trials, and commercial production.
