November 25, 2024

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Lotte Biologics CEO Richard Lee speaks to reporters at a press conference held at the JW Marriott San Francisco Union Square, in San Francisco, Monday. (Lotte Biologics)

SAN FRANCISCO -- Lotte Biologics will begin production of its antibody-drug conjugates at its US plant by the first quarter of 2025, according to its CEO Richard Lee, who spoke at a meeting with reporters on Monday, held on the sidelines of the J.P. Morgan Healthcare Conference.

As ADCs have emerged as a promising class of treatments, the Korean contract drug manufacturer has received a myriad of requests from potential clients to offer a full line of ADC services at its production site in Syracuse, New York. The company acquired the site from US drug firm Bristol Myers Squibb.

“We are preparing to become the largest hub for ADC conjugation technology in the US,” Lee said.

The Syracuse site, fully operational under Good Manufacturing Practice standards, provides drug substance manufacturing services with a total bioreactor production capacity of 40,000 liters. The site has received over 60 approvals worldwide from regulatory bodies such as the Food and Drug Administration, the European Medicines Agency, the Pharmaceuticals and Medical Devices Agency and Korea's Ministry of Food and Drug Safety.

“We have created a space for ADC production in the plant, but we are considering whether there will be synergies when making additional investments into a product finishing service,” he said.

In Korea, Lotte Biologics' production complex project is underway with a plan to construct three new bio plants in Incheon's Songdo by 2030. The combined bioreactor capacity of the three plants is expected to exceed 360,000 liters.

"Lotte Biologics' Bio Plant 1 in Songdo, which will break ground during the first quarter of this year, is set to be completed by April 2025. The plant will function as a mammalian cell culture facility, boasting a production capacity of 120,000 liters." Lee said.

The facility will incorporate the firm's "TiterFlex Quad Bioreactor System," featuring 3,000-liter stainless steel bioreactors for high-titer pharmaceutical manufacturing, in addition to serving current titer needs.

Lee highlighted the pivotal role of "design" in the contract development and manufacturing organizations within the bio sector, emphasizing its effectiveness in bridging the gap between market demand and supply capabilities.

"Many believe that the concept of 'designing' is exclusive to the realm of fashion and others, but it is equally applicable in the biopharmaceutical sector," Lee said. "Lotte Biologics will gradually transcend from being a production facility, to embodying innovative solutions that contribute to an enhanced quality of human life."

The company plans to actively undertake various design responsibilities, from the strategic allocation of human resources with management skills to the development of a robust IT system, according to Lee. This system is aimed at ensuring the consistent quality of essential pharmaceuticals, which are delivered on time to patients.

The CEO also prioritized talent management as a crucial factor in enhancing the overall system. In addition to partnerships established with institutions like Syracuse University and Korea Polytechnic University, the company launched an open innovation internship program to proactively secure top talent.

Since August 2023, more than 2,000 applicants have expressed interest in the program, with some 20 individuals among those having been selected as interns. The firm aims to leverage their potential, hoping they will contribute to and eventually become members of Lotte Biologics, according to Lee.

By Kim Hae-yeon (hykim@heraldcorp.com)