Lotte Biologics is set to officially enter the Songdo era, positioning itself at the center of the domestic contract development and manufacturing organization (CDMO) competition.
According to industry sources on July 14, Lotte Biologics has recently completed the usage approval for its Songdo Bio Campus Phase 1 facility and aims to finalize preparations for Good Manufacturing Practice (GMP) compliance about six months ahead of schedule by the end of this year.
The Songdo Phase 1 facility is equipped to produce 120,000 liters of antibody drugs. Combined with its Syracuse, New York plant, which has a capacity of 40,000 liters, Lotte Biologics' total production capacity will expand to 160,000 liters.
Market attention is focused on the company's contract achievements. Lotte Biologics secured four contracts in the first half of the year, including a contract manufacturing organization (CMO) agreement with the UK-based Otimopharma, although specific financial details have not been disclosed. An industry insider noted, "Securing long-term trust from clients to convert into large-scale commercial production contracts is ultimately more challenging and important than building the factory. We need to see substantial contract announcements that can be publicly disclosed."
Previously, CEO Park James stated at the BioUSA conference in San Diego last month that discussions for contracts with U.S. and European pharmaceutical companies are in the final stages, raising expectations for contract achievements in the second half of the year.
With the usage approval for the Songdo Phase 1 facility, the company is set to intensify its operational testing and validation procedures in the second half of the year, aiming to achieve 'GMP Ready' status and secure its first commercial production contract simultaneously. The second half of this year is expected to serve as a critical test for Lotte Biologics to demonstrate its capabilities through stable plant operations and contract acquisitions.
Lotte Biologics is targeting major clients in the U.S. and Europe. The company emphasizes its dual-site system connecting the Syracuse and Songdo plants to enhance its global customer response capabilities. However, large clients prioritize supply stability, quality, and long-term partnerships over pricing. This highlights the need for contract achievements that can demonstrate trust, beyond merely expanding production capacity.
In the bio industry, the interest of the group’s chairman holds significant symbolic value. Shin Dong-bin, chairman of Lotte Group, visited the Songdo Phase 1 facility on July 3, stating, "Biotechnology is a core industry that will lead the group's new leap forward," and urged the team to ensure that scheduled activities proceed without delays.
Lotte Group is investing heavily in its bio business. Earlier this month, Lotte Biologics decided to conduct a rights offering worth 255.3 billion won for existing shareholders. If this capital increase proceeds as planned, the total funds injected by Lotte Group into Lotte Biologics since its establishment in 2022 will approach 1.5 trillion won.
Lotte Biologics stated, "We will leverage the customer response experience gained at the Syracuse plant to develop the Songdo Phase 1 facility into a hub for large-scale commercial production contracts."
* This article has been translated by AI.
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