Lotte Biologics Racing Toward ADC, Technical Collaboration with NJ Bio

Lotte Biologics recently announced on the 22nd that it has signed a strategic business agreement with NJ Bio, a U.S.-based contract research organization (CRO) specializing in nonclinical and clinical studies, to provide a 'one-stop' antibody-drug conjugate (ADC) service.

Exterior view of Lotte Biologics' Syracuse plant in the United States [Photo by Lotte Biologics]

ADC is a technology that links antibodies that bind to cancer cells with cytotoxic drugs (payloads) that kill cancer, through a linker. Often referred to as a 'cruise missile' that precisely targets cancer, the breast cancer treatment 'Enhertu,' jointly developed by AZ and Daiichi Sankyo, has significantly extended patients' progression-free survival (PFS), intensifying competition in this technology field.

Lotte Biologics is also constructing an ADC production facility at its Syracuse plant in the U.S., aiming for completion in the first quarter of next year. Additionally, to internalize ADC capabilities, it signed a strategic partnership with Pinobio, an ADC platform specialist company, in April last year, and in July announced a joint development with the domestic bio venture Canap Therapeutics, demonstrating various open innovation efforts.

Founded in 2018, NJ Bio provides integrated chemical and biological services for ADCs, including linkers and payloads. It is said to possess specialized expertise in process development, analytical method development and validation, and stability studies. NJ Bio has pharmaceutical production facilities for clinical phases 1 and 2 in New Jersey, USA, and has won the top CRO award three consecutive times at the 'ADC World Summit,' the largest conference in the ADC field.

NJ Bio Company Logo
Photo by NJ Bio

Through this agreement, both companies plan to attract various new ADC clients based on their specialized technologies in the core components of ADC pipelines: payloads, linkers, antibodies, and conjugation. Producing ADC drugs requires manufacturing capabilities such as ▲ADC process development ▲analytical method development and validation ▲linker-payload development and synthesis ▲stability studies ▲preclinical and clinical phase 1 to 3 production capacity ▲clinical and commercial antibody drug production ▲commercial-scale ADC production.

NJ Bio will provide Lotte Biologics with technologies including ▲ADC process development ▲analytical method development ▲linker-payload development and synthesis, and Lotte Biologics plans to utilize these to offer ▲preclinical research ▲clinical and commercial antibody and ADC manufacturing services to clients. The jointly developed bio-conjugation process will be applied at the upcoming Syracuse ADC production facility.

A Lotte Biologics official stated, “We expect to generate mutual synergy by combining NJ Bio’s strengths in conjugation and linker-payload synthesis with Lotte Biologics’ expertise in antibody drug manufacturing,” adding, “Based on this business agreement, the Syracuse site in the U.S. will soon establish itself as the premier ADC specialized contract manufacturing service center in North America.”

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