Lotte Biologics, leading the charge in the Contract Development and Manufacturing Organization (CDMO) sector for monoclonal antibody drugs and antibody-drug conjugates (ADC), is set to revolutionize pharmaceutical production by early 2027.

The recent acquisition of Bristol Myers Squibb's biopharmaceutical production facility in Syracuse, New York, on December 31, 2022, catapulted Lotte Biologics into the bio-pharmaceutical CDMO market. The acquisition not only included state-of-the-art production facilities but also saw the retention of 99.2% of the existing BMS employees, including key personnel boasting an average bio-industry experience of over 15 years.

Lotte Biologics strategically plans to establish a South Korean bio plant in Songdo, Incheon, complementing its fully operational Syracuse facility, aiming to position it as a core hub. The company is actively pursuing the expansion of production lines to continuously secure pharmaceutical production capabilities (CAPA) and enhance competitiveness in the CDMO business.

During this year's JP Morgan Healthcare Conference, Lotte Biologics CEO Won-Jik Lee unveiled plans for the Songdo Bio Plant, emphasizing the crucial role of 'design' in creating flexible and sophisticated pharmaceutical production facilities, addressing the demand and supply gap in the CDMO market.

A Lotte Biologics official stated, "We are currently in the process of constructing a monoclonal antibody bio plant in Songdo. By 2030, our goal is to achieve a production capacity of 360,000 liters for monoclonal antibody drugs." The official added, "We are continuously exploring new treatment approaches and considering their integration into either two or three plants."

Simultaneously, Lotte Biologics is aggressively expanding its presence in the ADC CDMO sector. The recent strategic business agreement with NJ BIO, a specialized non-clinical and clinical Contract Research Organization (CRO) in the United States, aims to provide comprehensive ADC services. Both parties plan to attract new ADC clients based on their respective expertise in the core components of the ADC pipeline.

Lotte Biologics and NJ BIO will leverage their specialized technologies in the bio-conjugation process to jointly develop and apply them to the expanding ADC production facility on the Syracuse plant site in the United States. This collaboration aims to manufacture optimized ADC pharmaceuticals. Notably, Lotte Biologics participated as a new strategic investor (SI) in the Series C round of innovative drug development company Kanaph Therapeutics in December 2023, focusing on drug fusion technology-based innovations.

A Lotte Biologics representative stated, "Currently, the production of monoclonal antibody drugs is feasible at the Syracuse plant. We are constructing a facility at the Syracuse site for the conjugation of Payload and Linker with antibodies, aiming for GMP readiness by the first quarter of 2025. The facility is set to provide one-stop services for ADC, extending to filling and finishing (Fill & Finish)."

The representative further added, "Our Syracuse plant, located in New York, holds geographical advantages and employs over 420 staff with extensive industry experience. We are currently receiving inquiries related to ADC services from numerous clients." Lotte Biologics aims to break ground for the Songdo Bio Plant in March, with a target for completion by the end of 2025. The company plans to achieve GMP readiness in the second half of 2026, with commercial production slated to commence in early 2027. The representative emphasized the collaborative efforts of the team to ensure the smooth progress of the plans and mentioned ongoing recruitment initiatives for both new and experienced personnel.