Samsung Biologics will begin providing antibody-drug conjugate (ADC) contract development and manufacturing organization (CDMO) services starting in the first quarter of this year. The company noted that contracts for ADC new drug contract manufacturing (CMO) with various corporations are imminent, and it aims to offer services that complete the process from development to production within 12 months.
The ADC that Samsung Biologics has adopted as a new growth driver is a next-generation core technology for anticancer drugs, often referred to as a "guided missile" targeting cancer cells. By attaching drugs to antibodies and delivering them precisely to cancer cells, it achieves higher therapeutic efficacy than conventional anticancer agents while preventing damage to normal cells.
Jeong Sang-mu, executive director of the ADC development team at Samsung Biologics, said at a briefing during the JP Morgan Healthcare Conference in San Francisco on the 15th (local time), "There are currently only 15 ADC therapeutics approved by the U.S. Food and Drug Administration (FDA), but over 500 ADC candidate drugs are undergoing clinical trials," adding that contracts with various firms, including LigaChem Biosciences, are imminent.
Jeong served as a professor at the University of Southern California (USC), the University of Wisconsin, and the Seoul National University College of Veterinary Medicine before leading ADC research at LigaChem Biosciences. He joined Samsung Biologics in February last year.
Samsung Biologics is focusing on projects to win contracts at the JPM event. From the 16th, it plans to conduct ADC meetings across four cities in the United States. It is reported that the company will meet with over 80 corporations in the ADC field.
The key to ADC development and production lies in the consolidation of antibodies and linker-payload conjugation, purification and scale-up of target substances, and the development of analysis methods specific to ADC substances and formulations. Antibodies bind to specific antigen proteins on the surface of cancer cells. The payload is the active component that attaches to the antibody via a chemical linker. The linker connects the antibody and payload, reducing the amount of payload reaching non-tumor tissues.
Samsung Biologics' ADC business consists mainly of contract development organization (CDO), conjugation CMO, and quality analysis services. Through the company's research antibodies and linkers and payloads used in ADC drugs approved by the FDA, it has internalized process development technology.
Last month, Samsung Biologics constructed a dedicated production facility for ADC drugs in Songdo, Incheon. According to the company, this facility has a total of four floors, including two production lines with 500-liter conjugation reactors and one purification line. It is expected to be capable of producing up to 100 batches annually.
Jeong said, "We will provide services within 12 months, from the first cell line development to the completion of Good Manufacturing Practice (GMP) for the final drug at CDO client companies," noting that the goal is to accumulate know-how to shorten service times further.
The unsung hero of Samsung Biologics' ADC business is LigaChem Biosciences, a leading ADC player in Korea. The two companies signed a CDO contract in February last year and began collaborating on antibody development for ADC therapeutics. In June of that year, they proceeded with a material transfer agreement (MTA) for ADC development, and earlier this year, they commenced a business cooperation agreement for ADC projects, totaling three projects ongoing. Samsung Biologics intends to handle ADC new drug CMO, while LigaChem Biosciences will take charge of development as part of their strategy to complete the ADC business.
To strengthen ADC competitiveness, the company has been investing in ADC technology-holding corporations through the "Samsung Life Sciences Fund." In 2023, it invested in Araris Biotech in Switzerland and AimedBio, a domestic biotech company, and last year, it invested in BrickBio in the United States.
Jeong stated, "The ADC production process, which involves conjugating drugs to antibodies, is straightforward, but each corporation has different technologies, so monitoring and quickly understanding and implementing them are crucial for succeeding in the ADC business," adding, "When Samsung Biologics first started its antibody CDMO business, there were some concerns in the market, but just as it became a leading company in this field after 10 years, I am confident that the ADC business will also yield good results."