The global pharmaceutical and biotech industry is undergoing rapid transformation, driven by three key factors: geopolitical dynamics, evolving funding landscapes, and the emergence of cutting-edge technologies. The U.S. Biosecurity Act has elevated ‘onshoring’ from a strategic choice to an imperative requirement.
James Park, Chief Executive Officer (CEO) of Lotte Biologics, addressed reporters on Thursday near the Pacifico Yokohama venue, which is hosting BioJapan 2025. He asserted that amidst this seismic shift, Lotte Biologics is poised to become an innovative partner aligned with changing market trends and demands. It’ll leverage its dual site strategy, bridging the U.S. and South Korea, alongside the proven quality excellence.
This marks Lotte Biologics’ third consecutive participation in BioJapan. CEO Park delivered a seminar titled Redefining Pharma’s Future: Contract Development and Manufacturing Organization (CDMO) Strategies for Next-Gen Antibody-Drug Conjugates (ADCs).
Biosecurity Act Sparks Bio Supply Chain Overhaul
Park identified geopolitical factors as the most significant shift in the CDMO landscape, with the U.S. government’s intensified biosecurity regulations at the forefront.
The Biosecurity Act bars federal funding and contracts for biotech firms linked to designated adversary nations. Park noted that Executive Order 14293, issued in May, has further accelerated domestic production of critical medicines in the U.S.
He emphasized that the message to CDMOs is unequivocal: establishing U.S.-based production facilities is now crucial for survival.
In response, several global pharmaceutical giants are ramping up U.S. investments, with long-term plans to expand domestic manufacturing capabilities.
Park predicts that the presence of local manufacturing hubs will become the decisive factor in CDMO partnerships.
Syracuse, NY and Songdo, Incheon: Dual Sites as Geopolitical Risk Mitigation
Lotte Biologics is championing its dual site strategy as the definitive answer to geopolitical uncertainties. The company aims to forge a resilient and adaptable global supply network through its Syracuse bio campus in New York and the upcoming Songdo bio campus in Incheon.
The Syracuse facility boasts a 40,000-liter (about 10,570 gallons) capacity for antibody drug production. The Songdo campus’s first phase, slated for commercial operations in 2027, is projected to achieve a 120,000-liter (about 31,700 gallons) production capacity.
By securing manufacturing bases across two continents, Lotte Biologics plans to offer clients services insulated from region-specific geopolitical risks. This strategy aligns with their motto: Two Continents, One Standard, Zero Compromise.
The company intends to replicate the quality system of its Syracuse campus— which has garnered over 62 approvals from global regulatory bodies including the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)—at the Songdo facility.
The expertise of core personnel, each averaging over 15 years in biotech, will be seamlessly transferred to both locations.
Lotte Biologics has optimized production efficiency by integrating the entire process—from cell culture to antibody production, conjugation, purification, and packaging—at its Syracuse campus. The company is also enhancing its customized antibody-drug conjugate (ADC) solutions through collaborations with global biotech leaders.
BioJapan Booth Draws Over 400 Visitors
Lotte Biologics’ strategy resonated strongly at BioJapan. Their expanded booth, which is double the size of last year’s, attracted over 400 visitors. Beyond scheduled partnering sessions, numerous impromptu meetings took place on-site.
This year, Lotte Biologics has already announced three contract wins. The company anticipates securing additional deals based on its BioJapan success. Notably, Shin Yoo-yeol, Head of Global Strategy and Future Growth at Lotte Corporation, personally attended key meetings.
Park concluded by stating that driven by its mission to enhance global health, they’re committed to delivering high-quality therapeutics swiftly and reliably worldwide. Through continuous innovation and quality enhancement, they aim to spearhead the global CDMO market.