LOTTE BIOLOGICS Signs Strategic Business Agreement with NJ Bio for Providing End-to End Process Development, Clinical, and Commercial Bioconjugation Services for ADCs

■ This Agreement aims to provide end-to-end process development, clinical, and commercial bioconjugation services to ADC clients by synergistically combining the expertise of LOTTE BIOLOGICS in the antibody and late-stage clinical and commercial manufacturing of ADCs space and of NJ Bio in the area of ADC and linker-payloads in process and analytical development, optimization, qualification, validation, and stability. 

■ This Agreement also offers clients a unique benefit; a U.S. based LOTTE site in Syracuse, New York to manufacture ADCs for phase 3 clinical studies and support their production on a commercial scale.

LOTTE BIOLOGICS (CEO Richard Lee) announced on the 22nd that it had recently signed a strategic business agreement with NJ BIO (hereinafter referred to as NJ Bio), a Princeton, NJ US-based Contract Research Organization (CRO) specializing in development and clinical manufacturing of antibody drug conjugates (ADCs) and linker-payloads.

NJ Bio, established in 2018, provides integrated chemistry & biology services for ADCs and linker-payloads. NJ Bio has niche expertise in linker-payloads and ADCs, especially with respect to process development, analytical method development, qualification and validation, and stability studies. NJ Bio is capable of manufacturing clinical supplies for phase 1 and 2 studies at their NJ location. It has a robust record helping accelerate client ADC programs and it’s strong reputation and expertise in this space has won it accolades such as “The Best CRO Award” at the World ADC summit, three times in a row. More information about NJ Bio can be found on its website – www.njbio.com 

Bringing an ADC to market requires capabilities in manufacturing including ▲ADC process development, ▲analytical method development, method qualification and validation, ▲linker-payload development and synthesis, ▲stability studies, ▲preclinical and phase 1-3 clinical manufacturing capabilities, ▲clinical and commercial production of antibodies, and ▲ADC manufacturing on a commercial scale.

NJ Bio will provide LOTTE BIOLOGICS with technologies such as ▲ADC process development, ▲analytical method development, and ▲linker-payload development and synthesis. Utilizing these, LOTTE BIOLOGICS will offer services such as ▲ preclinical studies, ▲clinical and commercial product antibodies, and ADC manufacturing services to its clients. Through this agreement, both NJ Bio and LOTTE plan to bring great value to their clients by providing all these end-to-end manufacturing services for ADCs, including a site that LOTTE has been expanding in the U.S. to support ADC manufacture on a commercial scale.

A company official stated, "We expect to create mutual synergy by combining the strengths of NJ Bio, which excels in bioconjugation and linker-payload synthesis, with LOTTE BIOLOGICS, which is strong in antibody pharmaceutical manufacturing. Based on this strategic business agreement, the Syracuse site in the USA will soon become North America's premier ADC specialized contract manufacturing service center."

Meanwhile, LOTTE BIOLOGICS is engaging in various open innovations to internalize their ADC capabilities. In April, they signed a strategic business partnership with ADC platform specialist PinoBio, securing them as a priority supplier of antibodies and ADC production for their ADC pipeline. Additionally, in July, they announced a joint development with the domestic bio venture Kanaph Therapeutics for the internalization of their ADC technology platform.