Lotte Biologics Unveils Dual CDMO Strategy in U.S. and Korea
At JPM 2025, James Park, CEO of Lotte Biologics, outlined the company’s dual CDMO strategy. The company will focus on small- to medium-scale drug production - including ADCs - at their Syracuse, New York facility, while large-scale drug production will be handled at the planned Songdo bio-campus in Korea.
Park also highlighted how Lotte Biologics will differentiate itself by using a dual strategy instead of centralizing large-scale production - like competitors such as Samsung Biologics. The company’s Syracuse plant has met U.S. FDA standards, completed a 100 bn won (USD 69 mn) ADC production facility, and will begin GMP operations in Q1 2025, while its Songdo facility is set to start GMP operations in Q1 2027.
The following article originally appeared in Korea Biomedical Review.
Lotte Biologics has unveiled its contract development manufacturing (CDMO) ordering strategy centered on its Syracuse, New York, and Songdo bio-campuses at the 43rd J.P. Morgan Healthcare Conference (JPM 2025).
Lotte Biologics CEO James Park made the announcement last Thursday (local time) at the Asia-Pacific (APAC) track of JPM 2025 at the Westin St. Francis Hotel in San Francisco, Calif.
Lotte Biologics, Hugel, and Classys were among three Korean companies to present at the APAC track. The event drew the industry’s interest as Park, who worked at Merck, BMS, Samsung Biologics, and GC Cell, made his first official appearance as Lotte Biologics’ CEO since taking office last month.
“We want to redefine success in the CDMO space,” Park said. “We will focus on small- and medium-scale drug products, ADC production in the U.S., and large-scale drug production in Korea.
According to the announcement, Lotte Biologics’ Syracuse facility is fully operational and has demonstrated operational excellence by passing the U.S. Food and Drug Administration (FDA) due diligence with flying colors and shipping batches in an average of 40 days.
Notably, the 100 billion won ($68.8 million) antibody-drug conjugate (ADC) production facility has been completed. It is undergoing validation to prepare for GMP operation in the first quarter of this year.
“I will be visiting the Syracuse facility next week, and I am looking forward to seeing this wonderful facility,” Park said.
Park said the Syracuse facility will make antibody and ADC products, and the company’s North American pharmaceutical partners, who are finished-drug producers, will provide filling services, including liquid and lyophilized formulations, to the U.S. West, Midwest, and East regions.
Park also unveiled SoluFlex Link, an ADC platform co-developed with Korean biotech KANAPH Therapeutics.
“The platform is compatible with cleavable and non-cleavable linkers and enables the production of ADCs with high drug-to-antibody ratios,” Park said. “It shows improved performance in key areas, such as in vivo performance, pharmacokinetics, and therapeutic index.
“We completed the patent application last week and will provide additional information at the World ADC Conference in November,” he added.
Regarding the Songdo plant, the company is targeting the GMP operation of the first plant in the first quarter of 2027. The facility is equipped with 3,000-liter and 15,000-liter bioreactors. It has introduced advanced automation facilities, including a four-story automated warehouse, automated guided vehicles (AGVs), and cleaning systems.
“ESG principles, such as solar panels, district heating, and rainwater recycling, are at the core of our operations, along with manufacturing excellence,” Park emphasized.
During the Q&A after Mr. Park's presentation, a participant asked, “It's impressive to see such a bold strategy when there is a big competitor like Samsung Biologics, which has significant capacity and is expanding. How do you plan to differentiate from Samsung?”
“We are not competing in capacity, but rather pursuing a differentiated approach,” Park said. “Unlike Samsung, which has a large-scale production facility in one location, we are pursuing a dualized strategy of focusing on small- and medium-scale production in the U.S. and large-scale production in Korea, and we will continue to expand in the U.S.”
“Lotte Biologics may still be an unknown name in the CDMO industry, and the challenges ahead are great, but we also have great opportunities to create new possibilities in both the U.S. and Korea,” Park stressed.
“Our vision is to deliver therapeutics for a healthier world through advanced technology, flexible production, and a commitment to quality,” he said. “We will be a trusted partner in the efficient and reliable delivery of life-saving medicines.”
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