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.    

Read the full article:

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