Lotte Bio Accelerates Business "Starting ADC Production in 2025 and Domestic Manufacturing in 2026"

Investing 100 Billion in Syracuse Factory, USA
Complete ADC Production Facilities

Domestic Factory Planned in Songdo
Construction to Start This Year... Production Targeted for 2026
4 Trillion Investment to Secure 360,000ℓ Production Capacity

Lotte Biologics is accelerating the full-scale launch of its business. Having completed the acquisition of its factory in Syracuse, New York, USA, the company recently announced its goal to complete and start production at a manufacturing facility for antibody-drug conjugate (ADC) contract development and manufacturing organization (CDMO) market entry by 2025, a 'hot item' in the pharmaceutical and bio industries. Earlier, it revealed plans to invest $3 billion (approximately 4 trillion KRW) in a domestic factory, with groundbreaking expected within this year and production commencing by the end of 2026.

Michael Hausladen, head of Lotte Biologics' US branch, is giving a presentation at 'Bio Korea 2023' held on the 12th at COEX in Gangnam-gu, Seoul.
[Photo by Lee Chunhee]

On the 12th, Michael Hausladen, head of Lotte Biologics' U.S. branch, met with reporters at 'Bio Korea 2023' held at COEX in Gangnam-gu, Seoul, and stated that the specific start date for ADC contract manufacturing (CMO) is targeted for 2025. At the event, Hausladen said, "Lotte Biologics is adding capabilities related to ADCs," and "We have already started related investments totaling $80 million (approximately 106.6 billion KRW)." This follows CEO Lee Wonjik's announcement at the January JP Morgan Healthcare Conference (JPMHC) about constructing ADC production facilities at the Syracuse plant, with this occasion providing concrete investment figures and timeline goals.

As the name suggests, ADCs are pharmaceuticals that conjugate antibodies and drugs. By linking antibodies that bind to cancer antigens with cytotoxic drugs (payloads) that can kill cancer cells via a linker, ADCs can deliver toxins effectively only to cancer cells like missiles, earning the nickname 'cruise missiles' for cancer drug bombardment and attracting attention as next-generation anticancer technology. Competition among bio CDMO companies to preempt the CDMO market, expected to grow alongside ADCs, is intensifying. Especially since production capabilities must be secured for all components including antibodies, payloads, and linkers, this industry requires top-tier technology and rapid large-scale investment, according to analyses. Previously, Samsung Biologics also expressed ambitions to establish ADC production capabilities and start CDMO production by the first quarter of next year.

Additionally, the Syracuse plant, which currently has a production capacity of 35,000 liters, is known to be utilizing only about 30% of its total site area, and various further expansions are being considered. Hausladen said, "Since there is a lot of green space, the expansion capacity is large," and "We are adding production capacity." Besides ADCs, plans include investments to expand clinical drug production facilities and establish new drug product (DP) facilities.

Efforts are also underway to secure bases for full-scale contract development organization (CDO) business entry. Hausladen announced, "We are trying to establish new CDO offices in major U.S. regions," and "We are reviewing various locations including Boston and San Francisco." Since Boston and San Francisco, along with San Diego, are considered the three major U.S. bio clusters, it appears they are seeking optimal locations to leverage regional synergy effects.

A bird's-eye view of Lotte Biologics' 'Lotte Bio Campus'
[Photo by Lotte Biologics]

Lotte Biologics also revealed a blueprint for its domestic mega plant, the 'Lotte Bio Campus,' which is the other pillar of its two major strategies of 'acquisition and new construction.' Lotte Biologics plans to secure a total production capacity of 360,000 liters domestically with a total investment of $3 billion (approximately 4 trillion KRW). The site has been selected in Songdo, Incheon, and the company is in discussions with relevant government departments after submitting a letter of intent for the project.

Hausladen stated that the first factory among these will "break ground within this year, be technically completed in 2025, and start Good Manufacturing Practice (GMP) production in the second half of 2026." It will be equipped with eight 15,000-liter bioreactors, enabling a total commercial production capacity of 120,000 liters. The plan is not only to cover clinical product production capacity but also to include DP production. Once the second and third factories, expected to be built at similar scales, are completed, Lotte Biologics will have a total production capacity of 360,000 liters domestically.

Lotte Biologics aims to create a 'bio ecosystem' at the Lotte Bio Campus beyond just a factory. Hausladen said, "What I am most pleased about is the 'Bio Venture Initiative,' planned as the fourth building," describing it as "an incubation center for startups." He added, "Startups will be able to strengthen their expertise near production facilities and receive support to commercialize ideas and concepts," and "We want to build an ecosystem to facilitate smooth transitions."

Hausladen earned his bachelor's, master's, and doctoral degrees in chemical engineering from the University at Buffalo, New York, and has accumulated 21 years of experience in various fields such as technology and process development at Bristol Myers-Squibb (BMS). Notably, he also worked at the Syracuse plant in New York, which Lotte Biologics acquired from BMS.