Lotte Biologics sees ADC manufacturing capabilities in New York as key differentiator

At its 90-acre campus in central New York, South Korea’s Lotte Biologics has positioned itself as a U.S.-based single source antibody-drug conjugate (ADC) partner, from cell culture to conjugation. The contract development and manufacturing organization (CDMO) sees its services at Lotte’s Syracuse Bio Campus as an attractive option for customers looking to derisk and regionalize production amid geopolitical uncertainty.  

The company contends that the campus, a former Bristol Myers Squibb (BMS) site, is one of the few ADC conjugation sites on the East Coast and has one of the largest conjugation capabilities for ADC production in the U.S. A year ago, Lotte started full-scale operations at its new 45,000-square-foot ADC manufacturing facility in Syracuse.

“We’ve taglined it as an ADC facility but it’s really more than that — if you can conjugate it, we can do it,” said Ryan Stelick, senior director of manufacturing operations, who noted that the site supports modalities including ADCs, monoclonal antibodies, bispecific/multi-specific antibodies, and recombinant proteins. “We’re seeing a wide range of scale being requested and certainly a wide range of modalities within the conjugation space.”

Last year, Lotte completed a $100 million renovation of an existing building on campus that marked the official launch of its CDMO business. With the new ADC facility, the company is looking to support customers from clinical development through to commercial-scale production, offering end-to-end capabilities including conjugation, purification, in-house quality control testing, and aseptic filling.

The Syracuse Bio Campus provides comprehensive end-to-end clinical and commercial biologic drug substance manufacturing capabilities, including an on-site cell bank facility and cryogenic storage. The site’s infrastructure includes eight 5,000L stainless steel bioreactors, three inoculation suites, and two purification suites.

“We’re stainless [steel] for any mammalian cell production and single use from a conjugation standpoint,” Stelick said.  

Lotte is leveraging single-use systems for bioconjugation to reduce contamination risk while offering flexibility and rapid changeover to its customers, according to Brian Greven, general manager of the Syracuse Bio Campus.    

“We chose single use to be able to have quicker changeovers, simplify processes, and reduce risk with multi-product operations,” Greven added.    

Development and manufacturing

In 2022, Lotte Corporation paid $160 million to BMS for the commercial manufacturing site and Lotte Biologics became a CDMO in 2023, with Syracuse serving as the hub for its North American operations. Currently, Lotte has about 500 full-time employees — retaining 98% of the previous BMS workforce — which the company says are well-versed in current Good Manufacturing Practices (GMP) and have proven expertise in biologics.

Lotte’s Syracuse site in 2024 cleared audits by Japan’s Pharmaceuticals and Medical Devices Agency and the U.S. Food and Drug Administration, with no observations reported by the regulatory agencies.

“We retained a lot of talent, but we’ve also brought in a lot of talent — overall we have over 30 years of experience on site,” said Stephanie Wickham, head of development at the Syracuse site. “We’ve touched about every kind of mammalian cell out there. If a mammalian cell can express it, we can develop a process for it. We’re focused on bioconjugation as a whole — not just ADCs.”

Last year, Lotte signed a memorandum of understanding with Asimov to integrate cell line development technology with GMP manufacturing capabilities. Asimov’s CHO Edge platform uses synthetic biology and AI-driven analysis to optimize Chinese hamster ovary (CHO) cell lines for antibody and protein therapeutic production.

Lotte validated the scalability of the platform at its Syracuse site. Under the agreement with Asimov, the companies will offer end-to-end CDMO services, aiming to streamline the transition from cell line development to commercial-scale production. 

In Syracuse, Wickham said Lotte has “harmonized” the lab-scale and commercial-scale manufacturing, with the site’s development space set up as a miniature version of the production infrastructure to derisk the process and create a seamless transfer.

She noted the company has strategic partners to complement its core competencies, enabling it to offer end-to-end solutions from early development through commercial production.

In 2025, Lotte announced a partnership with SK pharmteco to offer integrated CDMO services spanning antibody drug substance, linker-payload production, and bioconjugation. Lotte will leverage GMP capabilities at its Syracuse site for drug substance manufacturing, while SK pharmteco will oversee linker-payload development and manufacturing. The companies hope to streamline the ADC supply chain and reduce handoff risks between drug substance and product manufacturing.

Last year, Lotte also announced a memorandum of understanding with Axcelead Drug Discovery Partners and Kanaph Therapeutics to co-develop an ADC toolbox platform. The agreement seeks to advance next-generation ADCs by combining each company’s specialized capabilities in payload, linker, and conjugation technologies.

Lotte’s proprietary ADC platform, SoluFlex Link, features a linker technology developed with Kanaph Therapeutics — a biotech venture specializing in drug-conjugation technology — designed for a wide range of antibodies and payloads in development and manufacturing to boost production efficiency and performance.

On the customer side, Lotte in 2025 announced a contract manufacturing agreement with Ottimo Pharma to produce antibody drug substance for its investigational cancer therapy, which will leverage Lotte’s Syracuse Bio Campus. In January 2026, Lotte announced a contract manufacturing agreement with Rakuten Medical to support the production in Syracuse of monoclonal antibody intermediates and conjugates for its oncology programs.

“We’re seeing a lot of appreciation for having a U.S. bioconjugation facility paired with our antibody facility,” Wickham said. “There’s some uptick because of the BIOSECURE Act and tariffs, others want to file in the U.S. We’re seeing multiple benefits of being U.S.-based because of these different levers.”

Dual sites, one quality system

Outside of the U.S., Lotte is investing $1 billion in its Songdo Bio Campus in South Korea, with Plant 1 construction scheduled for completion this year and the site slated for operation in the second quarter of 2027 — bringing online 120,000 liters of biopharmaceutical manufacturing capacity.  

When finished, it will expand the company’s global capacity to 160,000 liters, including 40,000 liters at its Syracuse Bio Campus. The goal is two sites — one in the U.S. and one in South Korea — with a unified quality system to ensure harmonized operations, according to Lotte.

“As a company, we’re investing in the large-scale investment in Songdo to demonstrate our dual-site strategy,” Stelick said. “We’re going to leverage teams at both sites to deliver at scales from early clinical through commercial production.”   

Greven called it an operating model of “two sites and one CDMO” with globally aligned policies and procedures.

“We’re leveraging the expertise from a quality standpoint, specifically as it relates to our regulatory history and our commercial track record to enable that site in South Korea to start up successfully,” he added.

Ultimately, the Songdo Bio Campus will include three production facilities, each with 120,000 liters of capacity. The plan is to build three plants at the Incheon site by 2030 and achieve full operation by 2034. Plant 1 is being built as a smart factory with digital and automation technologies to maximize efficiency, improve quality management, and enable process flexibility to meet the needs of global customers.

Stelick described the Syracuse Bio Campus as a “hybrid” facility when it comes to automation and data collection, which are designed to optimize process efficiency and help with changeovers and multi-client operations.

“With certain things, we have automated control and recipe-driven parameters,” he said. “Other things we keep more manual with automation and data backups. We’re a blend.”