Lotte Biologics opens Songdo Plant 1 two years after breaking ground, eyes big pharma deals by year-end

Lotte Biologics is moving to accelerate its push into the global contract development and manufacturing organization (CDMO) market following the completion of Plant 1 at its Songdo Bio Campus. The company aims to complete a dual-site production system linking its factory in Syracuse, New York, with the new Songdo facility in South Korea — and to achieve both Good Manufacturing Practice (GMP)-ready status and its first commercial production contract by the end of this year.

James Park, chief executive of Lotte Biologics, held a press briefing Tuesday (local time) on the sidelines of the 2026 BIO International Convention (BIO USA) in San Diego. "This is the journey that truly opens the Songdo era for Lotte Biologics — and the real start begins now," he said.

Songdo Plant 1 received its occupancy approval exactly two years after breaking ground. Biopharmaceutical production facilities typically take three and a half to four or more years to build, making the two-year compression a significant achievement. Park said the result reflected a relentless focus on speed, quality and safety in building a highly complex production infrastructure — one that must meet sterile-environment, cleanroom, ultrapure water and global current GMP requirements. "This is not simply about finishing construction quickly," he said. "It means we are ready to welcome customers faster than anyone expected."

Lotte Biologics also moved up its GMP-ready timeline by six months in response to market demand. The company had originally targeted the second quarter of next year but now plans to achieve GMP-ready status by the end of this year. Park said inquiries from global clients about when the factory would be operational had been coming in steadily, prompting the company to revise its internal schedule. "Starting in the second half of the year, we will move sequentially into commissioning and process and equipment qualification, and we plan to hold a completion ceremony in November," he said.

Songdo Plant 1 is designed to serve as a hub for large-scale commercial production rather than clinical-stage manufacturing. Under the dual-site model, drug candidates begin their clinical phase at the Syracuse campus, and once a product receives regulatory approval and commercial volumes grow, production transfers to Songdo for mass manufacturing. To support the transition, the company has launched a cross-rotation training program pairing Syracuse staff with newly hired Songdo personnel.

Park expressed confidence in securing concrete contracts before the year is out. "We are concentrating all our capabilities on making one or two major contracts visible by the end of this year," he said, adding that the clients currently in discussions are likely to be global big pharma companies.

Lotte Biologics is positioning production flexibility and a strong track record as its core competitive advantages. While leading global CDMO firms are operating near full capacity, Lotte says its available headroom in new capacity allows it to respond nimbly to sudden schedule changes from clients. The company also points to the quality systems at its Syracuse facility — which has a history of US Food and Drug Administration inspections — as a differentiator, noting that those proven systems are being replicated directly at Songdo.

Jang Jun-young, executive vice president and head of global business development at Lotte Biologics, said inquiries from multinational pharmaceutical companies seeking US-based production have been rising amid the push for a Biosecure Act. "Having a production site that US regulatory inspectors are already familiar with gives us a distinct advantage," he said.

The company's current modality focus centers on antibody therapeutics, while two to three new project discussions are also taking shape at the Syracuse facility's dedicated antibody-drug conjugate (ADC) plant. Lotte Biologics, which has announced four new contracts this year, has set a mid-to-long-term goal of breaking into the top 10 in the global CDMO market. Park said the company would build on the quality competitiveness already proven in Syracuse and successfully replicate it at Songdo to usher in an era of high-quality, large-scale production. "We will also review the sequential construction of Songdo Plants 2 and 3 as market demand and contract momentum develop," he said.