"We expect the antibody-drug conjugate (ADC) market to grow significantly, which is why we are investing $80 million in an ADC capacity expansion at our Syracuse Plant in New York City. Upon completion in the fourth quarter of 2024, we will be able to start GMP production in the first quarter of 2025."

Lotte Biologics CEO Richard Lee said so in Barcelona, Spain, last Friday, showing confidence in the company’s order receipts for its contract development and manufacturing organization (CDMO) business.

Lotte Biologics participated in the World Pharmaceutical and Biotechnology Exhibition (CPHI Worldwide 2023) from last Wednesday to Friday, operating an independent exclusive booth to introduce its CDMO production capacity at its Syracuse plant in the U.S. and Songdo Bio Plant in Incheon, along with its plans to create an ADC technology platform.

Lee explained that the Syracuse plant is operating stably, and the company has signed a contract with BMS, which transferred the Syracuse plant to the Korean company, to produce similar volumes next year as this year.

"There are many attempts to develop ADC, including those in China. However, considering various geopolitical factors, including de-risking from China, we expect our plant in the U.S. to benefit from the recent trend," Lee said. "Many companies, including Japanese ones, have offered to collaborate, and there are many discussions going on."

Lee went on to say, "I think what's important in ADC is the technology to conjugate the antibody, the payload (drug), and the linker. There are many types of payloads and linkers already available, and they are special technologies by themselves. Our job is to produce various combinations through quality control."

Lotte Biologics recently signed a land purchase agreement with the Incheon Free Economic Zone (IFEZ) to build a bioprocessing plant. The company will build three bio-plants in Block KI20, Songdo District 11, with a combined production capacity of 360,000 liters of antibody medicines by 2030.

According to Lotte Biologics, each plant can produce 120,000 liters of antibody medicines. The company plans to differentiate itself by installing eight 3,000-liter stainless steel bioreactors to meet high-titer drug demand at Plant No. 1 in Korea.

"We are pleased that Lotte Biologics has purchased the last remaining site in Songdo," Lee said. "The purchase was delayed a bit longer than expected, so we expect to break ground around March next year, complete construction in the fourth quarter of 2024, and start GMP production in late 2026 or early 2027 after a one-year validation period."

Asked about the reason for installing stainless steel bioreactors instead of single-use bags, Lee said, "Single-use systems are too dependent on the equipment supplier. Although they are environmentally friendly, the plastic waste generated by single-use is also high."

Regarding concerns that there will be insufficient electricity to run the factory due to delays in the construction of transmission lines in Songdo International City, he said, "It is true that the KEPCO project is being delayed. It will affect not only us but also many other companies. For Plant 1, however, there is no problem in building infrastructure."

Regarding the difference in business strategy from Samsung Biologics, which is running an active CDMO business in Songdo, he said, "The main difference is that we have a plant in the US. There is nothing more dangerous in the U.S. market than (drugs) having to travel back and forth on a plane. We are best optimized in that regard."

As if he were conscious of competition with Samsung Biologics to recruit talents and resultant legal battles, including business encroachment, Lee said, “Korea is a country where you have the freedom to change jobs. A lawsuit was dismissed, so the decisions are going in our favor. I think the same will happen with the other cases."

On the sales volume after 10 years, Kang Joo-eon, head of strategic planning at Lotte Biologics, said, "We are targeting 1.5 trillion won ($1.1 billion) in sales and 35 percent operating profit. Most of it is expected to come from antibody drugs. We have no plans to start a CDMO business for cellular gene therapy (CGT) yet."