[2024 JPMHC] Lotte Bio "Songdo and ADC Factories to Be Prepared with Quality-First Principle"

Iwonjik's Presentation at JP Morgan Healthcare Conference
Announces 'Songdo Bio Plant Construction Plan' Participating in APAC Track for 2 Consecutive Years

"We started construction of the Songdo Bio Plant earlier this year, and we plan to complete the antibody-drug conjugate (ADC) factory in Syracuse in the first quarter of next year. From the early stages of factory construction, we will establish a 'design' principle that prioritizes quality." (Wonjik Lee, CEO of Lotte Biologics)

Lee Won-jik, CEO of Lotte Biologics, is presenting at the JP Morgan Healthcare Conference (JPMHC) held in San Francisco, USA, on the 9th (local time).
[Photo by Lotte Biologics]

Wonjik Lee, CEO of Lotte Biologics, announced these plans on the 9th (local time) during his presentation and press briefing at the JP Morgan Healthcare Conference (JPMHC) held in San Francisco, California, USA. Lotte Biologics participated as a presenting company in the Asia-Pacific & Latin America track for the second consecutive year following last year.

At this JPMHC, Lotte Biologics focused on delivering more detailed plans for the Incheon Songdo production facility, which was unveiled last year. The company plans to build three factories with a total production capacity of 360,000 liters by 2030 on a 200,000㎡ site in Songdo District 11. Including the Syracuse factory in the United States, acquired from Bristol Myers-Squibb (BMS) last year, the total production capacity will reach 395,000 liters.

The start of the Songdo Bio Plant is the first factory, targeted for completion in 2026. In addition to a large-scale bioreactor (cell culture device) with a capacity of 15,000 liters, the plan includes systems to meet the demand for 'high potency' pharmaceuticals. Potency is a concept similar to the 'concentration' of antibodies. The idea is to produce high-concentration drugs to enhance drug efficacy and cost efficiency. CEO Lee said, "High-potency drugs are expected to take considerable time before actual commercialization," but added, "Once commercialized, large bioreactors will not be necessary, so we aim to have a flexible system that can operate with different sizes."

A bird's-eye view of Lotte Biologics' bio plant in Songdo, Incheon.
[Photo by Lotte Biologics]

Regarding the lack of significant external orders aside from BMS's Syracuse volume, he emphasized that he is not anxious. CEO Lee said, "We are continuing meetings and negotiations for orders," and lamented, "Since we cannot show the actual Songdo factory, securing sudden orders is difficult." However, he added, "When we first appeared on the global stage, no one knew what kind of company we were, but now we are being contacted first for collaboration. BMS volumes for Syracuse are somewhat secured until the year after next, and actual orders for Songdo will only be placed a year before completion, so for now, we are focusing more on promotion than orders."

In terms of business areas, the antibody-drug conjugate (ADC) production facility to be established in Syracuse in the first quarter of next year was highlighted as a core focus. The facility will include antibody production, toxic drug production, and the 'conjugation' facility that links these two components into one pharmaceutical product. CEO Lee said, "There is a strong market preference for finished product production (DP), so we are considering requests to handle DP as well," and added, "We are contemplating making this the only facility in North America capable of both conjugation and DP." He also mentioned that they are monitoring other areas such as cell and gene therapies, viral vectors, and messenger RNA (mRNA).

CEO Lee presented 'design' as the core management policy of the company, encompassing quality-focused system construction, workforce development, and corporate culture improvement. The plan includes experience-based system design by specialized personnel, internalization of quality systems, strengthening of both experienced and newly hired staff, and building an open innovation ecosystem. This approach aims to strengthen company management while continuing social contributions. The company plans to carry out the best design to maintain quality while operating efficiently and conveniently, and to directly train excellent Good Manufacturing Practice (GMP) professionals in collaboration with educational institutions. Regarding this, CEO Lee emphasized, "GMP is not achieved just by obtaining certification," and stated, "Since the entire culture, including company leadership, must be established, we prioritize this and are committed to a paradigm shift emphasizing quality from the early stages of factory construction."

Shin Yu-yeol, Head of Future Growth Office at Lotte Holdings and Head of Global Strategy Office at Lotte Biologics
[Photo by Lotte Holdings]

The open innovation ecosystem, including creating spaces to support the entire pharmaceutical and bio ecosystem, is led in part by Yoo-yeol Shin, head of global strategy at Lotte Biologics and eldest son of Lotte Group Chairman Shin Dong-bin. CEO Lee explained, "When ventures lack research equipment or facilities, we plan to collaborate, accelerate progress, and co-produce through investments," and added, "Yoo-yeol Shin is responsible for these tasks and cooperation through global networks."

This content was produced with the assistance of AI translation services.