Lotte Biologics said it has secured manufacturing capacity on par with the world’s top 10 contract development and manufacturing organizations (CDMOs), anchored by its Syracuse Bio Campus in the United States and its first manufacturing plant in Songdo, South Korea.
CEO James Park spoke at a press briefing held alongside the BIO International Convention 2026 (BIO USA) in San Diego on June 23.
The company recently received occupancy approval for its first manufacturing plant at the Songdo Bio Campus and has entered the final stage of facility installation.
Commissioning and quality management systems are currently being completed, while preparations for commercial production and customer orders are accelerating. Commercial manufacturing, originally scheduled to begin in 2027, has been moved up by about six months to the end of this year. An official completion ceremony is scheduled for November.
Park said the company is also aiming to achieve Good Manufacturing Practice (GMP) certification by the end of this year, about six months ahead of its original target of the second quarter of next year.
“We expect to achieve one or two meaningful milestones by the end of this year,” he said.
Lotte Biologics plans to strengthen its competitiveness in the global CDMO market by transferring the quality capabilities and operational expertise accumulated at its Syracuse facility, acquired from Bristol Myers Squibb (BMS) in 2023, to its Songdo plant.
“We will consider additional capacity expansion or further investment in the United States depending on market demand and customer orders,” Park said. “This is where the real journey begins. We are opening a new era of high-quality, large-scale manufacturing.”